search
Back to results

Telerehabilitation in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Multimodal treatment
Unimodal treatment
Sponsored by
Hospital Clínico La Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring pain, disability, education, exercise

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 20 years of age, severe CTS medical diagnosis, duration of symptoms for more than three months, access to a smartphone with internet, and acceptance to participate in the study.

Exclusion Criteria:

  • Inability to understand instructions, non-controlled mental health pathology, cognitive problems and previous surgery in the upper limb.

Sites / Locations

  • Hospital la Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal treatment

Unimodal treatment

Arm Description

Therapeutic Exercise plus Pain Neuroscience Education

Therapeutic Exercise

Outcomes

Primary Outcome Measures

Change from Baseline Pain Catastrophizing Scale (PCS) at 6 and 12 weeks
To assess catastrophic thinking as a response to pain through 13 statements with 4 possible options from 1 "not at all" to 4 "all the time". a higher score indicates a higher catastrophic thinking
Change from Baseline Tampa Scale for Kinesiophobia-11 (TSK-11) at 6 and 12 weeks
Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
Change from Baseline Numerical rating scale (NRS) at 6 and 12 weeks
The patient must rate his or her pain on a defined scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Secondary Outcome Measures

Change from Baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 and 12 weeks
The BCTQ measures self-reported functional status (BCTQ-F) and severity (BCTQ-S). The BCTQ-S consists of 11 questions, each question provides 5 response choices, from 1 (no symptoms) to 5 (most severe/often). The BCTQ-F includes 8 questions assessing difficulty with daily tasks. These responses are also scored on a 5-point scale (1-5).
Change from Baseline Hospital Anxiety and Depression Scale (HAD) at 6 and 12 weeks
Patient's emotional state will be evaluated by Hospital Anxiety and Depression Scale (HAD), which assess the level of anxiety and depression. Subscales and score range are Anxiety (0-21) and Depression (0-21). Scoring: items of each subscale are summed, indicating: 0-7 normality, 8-10 probably case, 11-21 anxiety or depression clinical case. Higher values represent a worse outcome.
Change from Baseline EQ-5D at 6 and 12 weeks
The EQ-5D is a self-assessed health-related quality of life questionnaire. The EQ-5D consists essentially of 2 pages: the EQ-5D description system and the visual analog scale (EQ VAS).
Hand diagrams
To define total area marked for pain and numbness. The areas of the hand are marked by the patient and the marked area is quantified in square centimeters.
Change from Baseline Muscular endurance at 6 and 12 weeks
Maximum number of repetitions of rapid opening and closing of the hand until fatigue.
Patient Global Impression of Change Scale (PGICS)
The PGICS consists of two subscales, one categorical and one quantitative. The categorical scale is a 7-point verbal scale with the options "I have improved a lot" = 7, "I have improved a lot" = 6, "I have improved a little" = 5, "I am the same" = 4, "I have gotten a little worse" = 3, "I have gotten a lot worse" = 2, "I have gotten a lot worse" = 1.205-207 And, the quantitative scale consists of a line from 0 to 10, where 0 = much better and 10 = much worse.
Patient Global Impression of Change Scale (PGICS)
The PGICS consists of two subscales, one categorical and one quantitative. The categorical scale is a 7-point verbal scale with the options "I have improved a lot" = 7, "I have improved a lot" = 6, "I have improved a little" = 5, "I am the same" = 4, "I have gotten a little worse" = 3, "I have gotten a lot worse" = 2, "I have gotten a lot worse" = 1.205-207 And, the quantitative scale consists of a line from 0 to 10, where 0 = much better and 10 = much worse.

Full Information

First Posted
November 27, 2021
Last Updated
August 2, 2022
Sponsor
Hospital Clínico La Florida
Collaborators
University of Chile, University of Valencia, Hospital San José, Hospital Provincia Cordillera
search

1. Study Identification

Unique Protocol Identification Number
NCT05184413
Brief Title
Telerehabilitation in Carpal Tunnel Syndrome
Official Title
Effectiveness of a Multimodal Telerehabilitation Program Combining Pain Neuroscience Education and Therapeutic Exercise for Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
July 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clínico La Florida
Collaborators
University of Chile, University of Valencia, Hospital San José, Hospital Provincia Cordillera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy characterized by pain, tingling sensation and paresthesia in the territory of the median nerve. These symptoms cause significant functional impairment that affects patients' quality of life. Pain neuroscience education (PNE) combined with therapeutic exercise (TE) has shown good results in patients with chronic pain, but the effects of this multimodal treatment via telerehabilitation have not been studied in patients with CTS. Telerehabilitation has demonstrated clinical and functional outcomes as effective as face-to-face interventions, being a good alternative to improve accessibility to rehabilitation care in a context of pandemic and social distancing. The purpose of this study is to provide coordinated, patient-centered care by implementing a Telerehabilitation model for patients with severe CTS. The objective of this study was to compare the effectiveness of a multimodal therapy program (TE plus PNE) versus a unimodal treatment (TE) in patients with CTS. A Randomized Controlled Trial, simple-blind and multicenter study will be conducted. Patients will be randomly assigned to the multimodal treatment group (TE plus PNE) or to the unimodal treatment group (TE). At admission, an investigator blinded to treatment assignment will conduct data collection. The measurements will be the following outcomes: a) Pain Catastrophizing Scale; b) Tampa Scale for Kinesiophobia-11; c) Numerical Rating Scale (NRS); d) Boston Carpal Tunnel Questionnaire; e) Hospital Anxiety and Depression Scale; f) Quality of Life, using the EQ-5D instrument; g) Patient's global impression of change; h) Katz Diagram; These evaluations will be performed again at week 6 and 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
pain, disability, education, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The investigator at each center responsible for conducting the study evaluations will be blinded to group assignment. A second investigator will be responsible for generating randomization, sequencing, enrolling participants, and assigning participants to treatment. Patients will be blinded to the assigned group
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimodal treatment
Arm Type
Experimental
Arm Description
Therapeutic Exercise plus Pain Neuroscience Education
Arm Title
Unimodal treatment
Arm Type
Active Comparator
Arm Description
Therapeutic Exercise
Intervention Type
Other
Intervention Name(s)
Multimodal treatment
Intervention Description
A multimodal telerehabilitation intervention will be conducted through Whatsapp video calls. The combined treatment includes: 1) One 30-minute session of education in neurosciences of pain, using audiovisual material with examples and metaphors to improve the patient's understanding. In addition, two sessions of reinforcement of key contents will be held every 15 days; 2) Therapeutic exercise program: active wrist and finger exercises, stretching, mobilization exercises of the median nerve, and aerobic exercise (brisk walking). Each exercise will be dosed on a personalized basis, with a perceived exertion of 4-5 on the Borg scale. Therapeutic exercise will be self-administered, 3 sessions per week for 6 weeks. Telerehabilitation sessions will be performed every 15 days to monitor adherence and adjust the exercise dose.
Intervention Type
Other
Intervention Name(s)
Unimodal treatment
Intervention Description
An unimodal telerehabilitation intervention will be performed through Whatsapp video calls. The treatment will include only a therapeutic exercise program: active wrist and finger exercises, stretching, mobilization exercises of the median nerve, and aerobic exercise (brisk walking). Each exercise will be dosed on a personalized basis, with a perceived exertion of 4-5 on the Borg scale. Therapeutic exercise will be self-administered, 3 sessions per week for 6 weeks. Telerehabilitation sessions will be performed every 15 days to monitor adherence and adjust the exercise dose.
Primary Outcome Measure Information:
Title
Change from Baseline Pain Catastrophizing Scale (PCS) at 6 and 12 weeks
Description
To assess catastrophic thinking as a response to pain through 13 statements with 4 possible options from 1 "not at all" to 4 "all the time". a higher score indicates a higher catastrophic thinking
Time Frame
Baseline (0 weeks), 6 weeks and 12 week
Title
Change from Baseline Tampa Scale for Kinesiophobia-11 (TSK-11) at 6 and 12 weeks
Description
Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
Time Frame
Baseline (0 weeks), 6 weeks and 12 week
Title
Change from Baseline Numerical rating scale (NRS) at 6 and 12 weeks
Description
The patient must rate his or her pain on a defined scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Time Frame
Baseline (0 weeks), 6 weeks and 12 week
Secondary Outcome Measure Information:
Title
Change from Baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 and 12 weeks
Description
The BCTQ measures self-reported functional status (BCTQ-F) and severity (BCTQ-S). The BCTQ-S consists of 11 questions, each question provides 5 response choices, from 1 (no symptoms) to 5 (most severe/often). The BCTQ-F includes 8 questions assessing difficulty with daily tasks. These responses are also scored on a 5-point scale (1-5).
Time Frame
Baseline (0 weeks), 6 weeks and 12 week
Title
Change from Baseline Hospital Anxiety and Depression Scale (HAD) at 6 and 12 weeks
Description
Patient's emotional state will be evaluated by Hospital Anxiety and Depression Scale (HAD), which assess the level of anxiety and depression. Subscales and score range are Anxiety (0-21) and Depression (0-21). Scoring: items of each subscale are summed, indicating: 0-7 normality, 8-10 probably case, 11-21 anxiety or depression clinical case. Higher values represent a worse outcome.
Time Frame
Baseline (0 weeks), 6 weeks and 12 week
Title
Change from Baseline EQ-5D at 6 and 12 weeks
Description
The EQ-5D is a self-assessed health-related quality of life questionnaire. The EQ-5D consists essentially of 2 pages: the EQ-5D description system and the visual analog scale (EQ VAS).
Time Frame
Baseline (0 weeks), 6 weeks and 12 week
Title
Hand diagrams
Description
To define total area marked for pain and numbness. The areas of the hand are marked by the patient and the marked area is quantified in square centimeters.
Time Frame
Baseline (0 weeks)
Title
Change from Baseline Muscular endurance at 6 and 12 weeks
Description
Maximum number of repetitions of rapid opening and closing of the hand until fatigue.
Time Frame
Baseline (0 weeks), 6 weeks and 12 week
Title
Patient Global Impression of Change Scale (PGICS)
Description
The PGICS consists of two subscales, one categorical and one quantitative. The categorical scale is a 7-point verbal scale with the options "I have improved a lot" = 7, "I have improved a lot" = 6, "I have improved a little" = 5, "I am the same" = 4, "I have gotten a little worse" = 3, "I have gotten a lot worse" = 2, "I have gotten a lot worse" = 1.205-207 And, the quantitative scale consists of a line from 0 to 10, where 0 = much better and 10 = much worse.
Time Frame
6 weeks
Title
Patient Global Impression of Change Scale (PGICS)
Description
The PGICS consists of two subscales, one categorical and one quantitative. The categorical scale is a 7-point verbal scale with the options "I have improved a lot" = 7, "I have improved a lot" = 6, "I have improved a little" = 5, "I am the same" = 4, "I have gotten a little worse" = 3, "I have gotten a lot worse" = 2, "I have gotten a lot worse" = 1.205-207 And, the quantitative scale consists of a line from 0 to 10, where 0 = much better and 10 = much worse.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 20 years of age, severe CTS medical diagnosis, duration of symptoms for more than three months, access to a smartphone with internet, and acceptance to participate in the study. Exclusion Criteria: Inability to understand instructions, non-controlled mental health pathology, cognitive problems and previous surgery in the upper limb.
Facility Information:
Facility Name
Hospital la Florida
City
Santiago
Country
Chile

12. IPD Sharing Statement

Learn more about this trial

Telerehabilitation in Carpal Tunnel Syndrome

We'll reach out to this number within 24 hrs