search
Back to results

Injection Versus Splinting in Carpal Tunnel Syndrome (INSTinCTS)

Primary Purpose

Carpal Tunnel Syndrome (CTS)

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Depo-Medrone
Wrist Splint
Sponsored by
Keele University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome (CTS) focused on measuring hand, wrist, carpal, tunnel, syndrome, pragmatic, randomised, steroid, splint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged ≥ 18 years
  • A clinical diagnosis of unilateral or bilateral CTS as made by a GP or trained clinician according to the diagnostic criteria
  • Mild (e.g. intermittent paraesthesia) or moderate (e.g. constant paraesthesia, reversible numbness and / or pain) severity CTS of idiopathic nature
  • Symptom duration of episode of at least 6 weeks
  • Written informed consent provided by the patient, prior to any trial specific procedures

Exclusion Criteria:

  • Steroid injection or night splints for CTS in the affected wrist within preceding 6 months
  • Any previous surgery on the affected wrist
  • Severe CTS exhibiting constant numbness or pain, constant sensory loss, severe thenar muscle atrophy or symptom severity which requires the patient to be referred for a surgical opinion
  • Clinical suspicion of local or systemic sepsis or infection
  • Current or previous infection of the affected wrist
  • Trauma to the affected hand requiring surgery or immobilisation in the previous 12 months
  • Unable to tolerate the study interventions
  • Unable to understand and complete self-report questionnaires written in English

  • Inter-current illness including, but not limited to:

    • poorly controlled thyroid disease
    • poorly controlled diabetes mellitus
    • vibration-induced neuropathy
    • inflammatory joint disease
    • suspected complex neurological conditions
    • any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation
  • Pregnant or lactating females
  • Receiving anticoagulants
  • Any history of hypersensitivity to Depo-Medrone or any of its excipients
  • Allergy to any of the splint materials
  • Known abuse of drugs or alcohol
  • Involved in on-going litigation cases for their condition

Sites / Locations

  • Staffordshire and Stoke on Trent Partnership NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Steroid Injection

Wrist Splint

Arm Description

Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)

Wrist splint to be worn at night

Outcomes

Primary Outcome Measures

Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire

Secondary Outcome Measures

BCTQ Symptom Severity Subscale 6 Weeks
Comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Functional Limitations Subscale 6 Weeks
Comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (1-5 scale, higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Hand-wrist Pain Intensity 6 Weeks
Comparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain).
Insomnia Due to Hand-wrist Problems 6 Weeks
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia.
Referral for Surgery 6 Weeks
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 weeks. Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Surgery 6 Weeks
Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 weeks. Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
BCTQ Symptom Severity and Functional Limitations 6 Months
Comparison of overall BCTQ between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Symptom Severity Subscale 6 Months
Comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Functional Limitations Subscale 6 Months
Comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Hand-wrist Pain Intensity 6 Months
Comparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain.
Insomnia Due to Hand-wrist Problems 6 Months
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia.
Referral to Surgery 6 Months
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months.
Surgery 6 Months
Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months.
Herbal Remedies and Vitamin Use 6 Months
Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months
Over the Counter Pain Medication 6 Months
Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months.
Prescribed Pain Medication 6 Months
Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months.
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up. Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire.
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire.
Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire
Hand-wrist Pain Intensity Over 24 Months: 6 Weeks
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 weeks.
Hand-wrist Pain Intensity Over 24 Months: 6 Months
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 months.
Hand-wrist Pain Intensity Over 24 Months: 12 Months
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 12 months.
Hand-wrist Pain Intensity Over 24 Months: 24 Months
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 24 months.
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))
Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Symptom Severity Subscale 6 Weeks (CC)
Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Functional Limitations Subscale 6 Weeks (CC)
Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Hand-wrist Pain Intensity 6 Weeks (CC)
Sensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Insomnia Due to Hand-wrist Problems 6 Weeks (CC)
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.
BCTQ Symptom Severity and Functional Limitations 6 Months (CC)
Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Symptom Severity Subscale 6 Months (CC)
Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Functional Limitations Subscale 6 Months (CC)
Sensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Hand-wrist Pain Intensity 6 Months (CC)
Sensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Insomnia Due to Hand-wrist Problems 6 Months (CC)
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
Referral to Surgery 6 Months (CC)
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
Herbal Remedies and Vitamin Use 6 Months (CC)
Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months. Sensitivity analysis for comparison of the odds of herbal remedies and vitamin use between treatment groups at 6 months follow-up on participants with complete data. Complete case analysis as a sensitivity analysis was planned. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Over the Counter Pain Medication 6 Months (CC)
Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months. Sensitivity analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.
Prescribed Pain Medication 6 Months (CC)
Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months. Sensitivity analysis for comparison of the odds of pain medication use between treatment groups at 6 months follow-up on participants with complete data.
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))
Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Symptom Severity Subscale 6 Weeks (PP)
Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Functional Limitations Subscale 6 Weeks (PP)
Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Hand-wrist Pain Intensity 6 Weeks (PP)
Per protocol analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain) on participants with complete data.
Insomnia Due to Hand-wrist Problems 6 Weeks (PP)
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.
BCTQ Symptom Severity and Functional Limitations 6 Months (PP)
Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Symptom Severity Subscale 6 Months (PP)
Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Functional Limitations Subscale 6 Months (PP)
Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Hand-wrist Pain Intensity 6 Months (PP)
Per protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Insomnia Due to Hand-wrist Problems 6 Months (PP)
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
Referral to Surgery at 6 Months (PP)
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. Per protocol analysis for comparison of the odds of surgery between treatment groups at 6 months follow-up on participants with complete data.
Herbal Remedies and Vitamin Use 6 Months (PP)
Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months. Per protocol analysis for comparison of the odds of herbal remedies and vitamin use between treatment groups at 6 months follow-up on participants with complete data. Per protocol analysis on complete date was planned. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Over the Counter Pain Medication 6 Months (PP)
Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data
Prescribed Pain Medication 6 Months (PP)
Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)
Subgroup analysis was performed in patients who were allocated the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)
Subgroup analysis was performed in patients who did not receive the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)
Subgroup analysis was performed in patients who did not state a preference of intervention. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)
Subgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)
Subgroup analysis was performed in patients who preferred splint. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
NHS Cost Differences at 6 Months
Cost of interventions at 6 months
NHS Cost Differences at 6 Months (CC)
Complete case analysis on the cost of interventions at 6 months
NHS Cost Differences at 12 Months
Cost of interventions at 12 months
NHS Cost Differences at 24 Months
Cost of interventions at 24 months
QALYS at 6 Months (Cross-walk Tariff)
The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
QALYS at 12 Months (Cross-walk Tariff)
The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
QALYS at 24 Months (Cross-walk Tariff)
The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.

Full Information

First Posted
January 9, 2014
Last Updated
March 16, 2023
Sponsor
Keele University
Collaborators
Arthritis Research UK
search

1. Study Identification

Unique Protocol Identification Number
NCT02038452
Brief Title
Injection Versus Splinting in Carpal Tunnel Syndrome
Acronym
INSTinCTS
Official Title
Randomised, Multicentre, Open Label, Parallel Group Pragmatic Clinical Trial of Local Steroid Injection Versus Night Splinting in Mild to Moderate Carpal Tunnel Syndrome (CTS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
February 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keele University
Collaborators
Arthritis Research UK

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Carpal Tunnel Syndrome (CTS) is a common condition in which a nerve (known as the median nerve) is squeezed where it passes through the wrist. It can cause pain or aching, tingling or numbness in the affected hand. It may disturb sleep, or affect ability to do day to day things. There have been several studies into the best treatment of patients with severe symptoms of CTS who are referred to a hospital for treatment. However, little is known about the best treatments for patients with mild to moderate symptoms who visit their GP but do not require hospital treatment. The study will investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the short term (6 weeks) compared to a night splint in people consulting with mild to moderate CTS in primary care.We will study the effects of these 2 treatments over 6 weeks and at 6 months. Subject to further funding, the Study will also look at whether these 6 weeks of treatment are effective 1 year and 2 years later. The study will take place in up to 50 GP practices and hospital clinics across the UK. Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been present for at least 6 weeks will be eligible for inclusion. The steroid is a drug called "DepoMedrone." This drug is already widely used to treat CTS. In this study, one injection will be given. The splint is made of elastic and has an aluminium bar which sits on the palm of the hand. In this study, the splint will be worn at night for 6 weeks. Each participant will receive either a single steroid injection or a splint, and will be asked to complete up to 5 questionnaires over 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome (CTS)
Keywords
hand, wrist, carpal, tunnel, syndrome, pragmatic, randomised, steroid, splint

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Steroid Injection
Arm Type
Active Comparator
Arm Description
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Arm Title
Wrist Splint
Arm Type
Active Comparator
Arm Description
Wrist splint to be worn at night
Intervention Type
Drug
Intervention Name(s)
Depo-Medrone
Intervention Description
Steroid Injection
Intervention Type
Device
Intervention Name(s)
Wrist Splint
Other Intervention Name(s)
Generic wrist splint
Intervention Description
Simple wrist splint
Primary Outcome Measure Information:
Title
Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
Description
Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
BCTQ Symptom Severity Subscale 6 Weeks
Description
Comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
BCTQ Functional Limitations Subscale 6 Weeks
Description
Comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (1-5 scale, higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
Hand-wrist Pain Intensity 6 Weeks
Description
Comparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain).
Time Frame
6 weeks
Title
Insomnia Due to Hand-wrist Problems 6 Weeks
Description
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia.
Time Frame
6 weeks
Title
Referral for Surgery 6 Weeks
Description
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 weeks. Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Time Frame
6 weeks
Title
Surgery 6 Weeks
Description
Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 weeks. Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Time Frame
6 weeks
Title
BCTQ Symptom Severity and Functional Limitations 6 Months
Description
Comparison of overall BCTQ between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 months
Title
BCTQ Symptom Severity Subscale 6 Months
Description
Comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 months
Title
BCTQ Functional Limitations Subscale 6 Months
Description
Comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 months
Title
Hand-wrist Pain Intensity 6 Months
Description
Comparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain.
Time Frame
6 months
Title
Insomnia Due to Hand-wrist Problems 6 Months
Description
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia.
Time Frame
6 months
Title
Referral to Surgery 6 Months
Description
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months.
Time Frame
6 months
Title
Surgery 6 Months
Description
Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months.
Time Frame
6 months
Title
Herbal Remedies and Vitamin Use 6 Months
Description
Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months
Time Frame
6 months
Title
Over the Counter Pain Medication 6 Months
Description
Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months.
Time Frame
6 months
Title
Prescribed Pain Medication 6 Months
Description
Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months.
Time Frame
6 months
Title
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks
Description
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months
Description
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up. Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire.
Time Frame
6 months
Title
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months
Description
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire.
Time Frame
12 months
Title
Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months
Description
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
24 months
Title
Hand-wrist Pain Intensity Over 24 Months: 6 Weeks
Description
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 weeks.
Time Frame
6 weeks
Title
Hand-wrist Pain Intensity Over 24 Months: 6 Months
Description
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 months.
Time Frame
6 months
Title
Hand-wrist Pain Intensity Over 24 Months: 12 Months
Description
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 12 months.
Time Frame
12 months
Title
Hand-wrist Pain Intensity Over 24 Months: 24 Months
Description
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 24 months.
Time Frame
24 months
Title
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))
Description
Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
BCTQ Symptom Severity Subscale 6 Weeks (CC)
Description
Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
BCTQ Functional Limitations Subscale 6 Weeks (CC)
Description
Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
Hand-wrist Pain Intensity 6 Weeks (CC)
Description
Sensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Time Frame
6 weeks
Title
Insomnia Due to Hand-wrist Problems 6 Weeks (CC)
Description
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.
Time Frame
6 weeks
Title
BCTQ Symptom Severity and Functional Limitations 6 Months (CC)
Description
Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 months
Title
BCTQ Symptom Severity Subscale 6 Months (CC)
Description
Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 months
Title
BCTQ Functional Limitations Subscale 6 Months (CC)
Description
Sensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 months
Title
Hand-wrist Pain Intensity 6 Months (CC)
Description
Sensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Time Frame
6 months
Title
Insomnia Due to Hand-wrist Problems 6 Months (CC)
Description
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
Time Frame
6 months
Title
Referral to Surgery 6 Months (CC)
Description
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
Time Frame
6 months
Title
Herbal Remedies and Vitamin Use 6 Months (CC)
Description
Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months. Sensitivity analysis for comparison of the odds of herbal remedies and vitamin use between treatment groups at 6 months follow-up on participants with complete data. Complete case analysis as a sensitivity analysis was planned. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Time Frame
6 months
Title
Over the Counter Pain Medication 6 Months (CC)
Description
Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months. Sensitivity analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.
Time Frame
6 months
Title
Prescribed Pain Medication 6 Months (CC)
Description
Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months. Sensitivity analysis for comparison of the odds of pain medication use between treatment groups at 6 months follow-up on participants with complete data.
Time Frame
6 months
Title
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))
Description
Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
BCTQ Symptom Severity Subscale 6 Weeks (PP)
Description
Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
BCTQ Functional Limitations Subscale 6 Weeks (PP)
Description
Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
Hand-wrist Pain Intensity 6 Weeks (PP)
Description
Per protocol analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain) on participants with complete data.
Time Frame
6 weeks
Title
Insomnia Due to Hand-wrist Problems 6 Weeks (PP)
Description
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.
Time Frame
6 weeks
Title
BCTQ Symptom Severity and Functional Limitations 6 Months (PP)
Description
Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 months
Title
BCTQ Symptom Severity Subscale 6 Months (PP)
Description
Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 months
Title
BCTQ Functional Limitations Subscale 6 Months (PP)
Description
Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 months
Title
Hand-wrist Pain Intensity 6 Months (PP)
Description
Per protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Time Frame
6 months
Title
Insomnia Due to Hand-wrist Problems 6 Months (PP)
Description
Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
Time Frame
6 months
Title
Referral to Surgery at 6 Months (PP)
Description
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. Per protocol analysis for comparison of the odds of surgery between treatment groups at 6 months follow-up on participants with complete data.
Time Frame
6 months
Title
Herbal Remedies and Vitamin Use 6 Months (PP)
Description
Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months. Per protocol analysis for comparison of the odds of herbal remedies and vitamin use between treatment groups at 6 months follow-up on participants with complete data. Per protocol analysis on complete date was planned. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
Time Frame
6 months
Title
Over the Counter Pain Medication 6 Months (PP)
Description
Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data
Time Frame
6 months
Title
Prescribed Pain Medication 6 Months (PP)
Description
Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.
Time Frame
6 months
Title
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)
Description
Subgroup analysis was performed in patients who were allocated the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)
Description
Subgroup analysis was performed in patients who did not receive the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)
Description
Subgroup analysis was performed in patients who did not state a preference of intervention. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)
Description
Subgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)
Description
Subgroup analysis was performed in patients who preferred splint. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time Frame
6 weeks
Title
NHS Cost Differences at 6 Months
Description
Cost of interventions at 6 months
Time Frame
6 months
Title
NHS Cost Differences at 6 Months (CC)
Description
Complete case analysis on the cost of interventions at 6 months
Time Frame
6 months
Title
NHS Cost Differences at 12 Months
Description
Cost of interventions at 12 months
Time Frame
12 months
Title
NHS Cost Differences at 24 Months
Description
Cost of interventions at 24 months
Time Frame
24 months
Title
QALYS at 6 Months (Cross-walk Tariff)
Description
The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
Time Frame
6 months
Title
QALYS at 12 Months (Cross-walk Tariff)
Description
The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
Time Frame
12 months
Title
QALYS at 24 Months (Cross-walk Tariff)
Description
The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged ≥ 18 years A clinical diagnosis of unilateral or bilateral CTS as made by a GP or trained clinician according to the diagnostic criteria Mild (e.g. intermittent paraesthesia) or moderate (e.g. constant paraesthesia, reversible numbness and / or pain) severity CTS of idiopathic nature Symptom duration of episode of at least 6 weeks Written informed consent provided by the patient, prior to any trial specific procedures Exclusion Criteria: Steroid injection or night splints for CTS in the affected wrist within preceding 6 months Any previous surgery on the affected wrist Severe CTS exhibiting constant numbness or pain, constant sensory loss, severe thenar muscle atrophy or symptom severity which requires the patient to be referred for a surgical opinion Clinical suspicion of local or systemic sepsis or infection Current or previous infection of the affected wrist Trauma to the affected hand requiring surgery or immobilisation in the previous 12 months Unable to tolerate the study interventions Unable to understand and complete self-report questionnaires written in English Inter-current illness including, but not limited to: poorly controlled thyroid disease poorly controlled diabetes mellitus vibration-induced neuropathy inflammatory joint disease suspected complex neurological conditions any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation Pregnant or lactating females Receiving anticoagulants Any history of hypersensitivity to Depo-Medrone or any of its excipients Allergy to any of the splint materials Known abuse of drugs or alcohol Involved in on-going litigation cases for their condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Roddy, Fellow RCP
Organizational Affiliation
Keele University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Staffordshire and Stoke on Trent Partnership NHS Trust
City
Newcastle under Lyme
State/Province
Staffordshire
ZIP/Postal Code
ST5 1QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Keele University is a member of the UK Reproducibility Network and committed to the principles of the UK Concordat on Open Research Data. The School of Medicine and Keele Clinical Trials Unit have a longstanding commitment to sharing data from our studies to improve research reproducibility and to maximise benefits for patients, the wider public, and the health and care system. We encourage collaboration with those who collected the data, to recognise and credit their contributions. The School of Medicine and Keele Clinical Trials Unit make data available to bona-fide researchers upon reasonable request via open or restricted access through a strict controlled access procedure. The release of data may be subject to a data use agreement (DUA) between the Sponsor and the third party requesting the data. In the first instance, data requests and enquiries should be directed to medicine.datasharing@keele.ac.uk.
Citations:
PubMed Identifier
27716159
Citation
Chesterton LS, Dziedzic KS, van der Windt DA, Davenport G, Myers HL, Rathod T, Blagojevic-Bucknall M, Jowet SM, Burton C, Roddy E, Hay EM. The clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol. BMC Musculoskelet Disord. 2016 Oct 6;17(1):415. doi: 10.1186/s12891-016-1264-8.
Results Reference
background
PubMed Identifier
30343858
Citation
Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1.
Results Reference
result

Learn more about this trial

Injection Versus Splinting in Carpal Tunnel Syndrome

We'll reach out to this number within 24 hrs