Back to resultsImpact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery.
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multimodal conservative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion:
- Have been diagnosed with Carpal Tunnel Syndrome (CTS) after the electrophysiological test at the neurophysiology service of the Miguel Servet Hospital in Zaragoza and be on the waiting list for CTS surgery.
- Have experienced symptoms for more than two months.
- Have sufficient comprehension and communication skills to communicate their symptoms and to fill in the questionnaires.
- Ability to maintain supine and lateral decubitus without causing symptoms or altering the patient's condition.
- Accept and give consent to participate voluntarily in the study.
Exclusion:
- Previous carpal tunnel surgery on the same limb.
- History of trauma on the upper limb which CTS may be associated, other musculoskeletal or neurological pathologies affecting the upper limb (e.g., cervical radiculopathy).
- Pregnancy, due to the influence of fluid retention in the cause of CTS, remitting spontaneously after childbirth, breastfeeding or up to 3 years after these episodes.
- Present physical contraindications (red flags) in general that contraindicate physical treatment such as: trauma, malignancy, inflammation, infection, fever... or psychological contraindications (yellow flags) that may have a marked effect on the results of treatment.
- Present specific physical contraindications that contraindicate diacutaneous fibrolysis treatment, such as ulcerations and skin alterations.
- Have specific contraindications that contraindicate surgical intervention such as taking anticoagulants or antiplatelet agents.
- Having received a steroid injection in the previous 6 months or interventions on the CTS in the previous 3 months.
- Pending trial or litigation related to CTS.
Sites / Locations
- Faculty of Health of Science, University of Zaragoza
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Multimodal Conservative Treatment
Standard healthcare.
Arm Description
Outcomes
Primary Outcome Measures
Change in nocturnal symptoms intensity (VAS)
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (nocturnal symptoms) orientated from the left (worst) to the right (best). Nocturnal sumptoms were measured in the last 3 days.
Change in pain intensity (VAS)
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best). Pain was measured in the last 3 days and currently.
Change in paresthesia intensity (VAS)
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (paresthesia) orientated from the left (worst) to the right (best). Paresthesia was measured in the last 3 days and currently.
Change in BCTQ
The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome.
Change in DASH questionnaire
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Secondary Outcome Measures
Change in NRS
Change between baseline, post-treatment, 3 months after, 6 months after
Change in Katz's Diagram
Katz hand diagram is a drawing made by a patient of symptoms such as numbness, tingling, or pain affecting the hand and fingers. The drawing is a useful means of eliciting symptoms that suggest carpal tunnel syndrome.
Change in MOS Sleep Scale
The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache.
Change in SF-36
The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health.
Change in TSK
The Tampa Scale of Kinesiophobia (TSK) is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
Change in ULTT
The Upper Limb Tension Test is performed to assess mechanosensitivity of median nerve. Range of movement, symptom's location, symptoms response and structural differentiation were assessed.
Change in Strength
Pinch and grip strength were assessed by a manual dynamometer to evaluate forearm, hand and fingers muscle strength.
Change in SWMT
The Semmes-Weinstein monofilament test (SWMT) is a clinical widely used test to quantify the sensibility in patients with Carpal Tunnel Syndrome (CTS).
Change in Neuropen
The Neuropen combines an interchangeable 10 g monofilament for cutaneous pressure assessment, and a calibrated sterile Neurotip for assessing pain sensation.
Change in PGI-I
The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05130931
Brief Title
Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery.
Official Title
Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery: Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
November 3, 2022 (Actual)
Study Completion Date
February 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
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
STC is considered one of the most prevalent peripheral neuropathy of the upper quadrant. Systematic review shows that conservative treatment is effective for treatment of CTS. In Spain, most patients diagnosed by CTS are included in surgery list without considering conservative treatment as first option or providing drugs or night splint . However, surgical treatment is not always necessary for these patients, and waiting list delays can lead to aggravation of patients' symptoms.
Researches believe that performing a conservative treatment including diacutaneous fibrolysis on carpal tunnel syndrome patients, could reduce waiting surgery list, reduce the cost-effectiveness rate of the surgical process and improve patient's satisfaction and clinical findings. In addition, patients of any level of severity and with systemic pathology will be included to define which patients would benefit from surgical treatment and which from physiotherapeutic treatment.
The aim is to find out the impact of a multimodal physiotherapy treatment in patients with Carpal Tunnel Syndrome (CTS) on the patient and the Aragonese Health System.
A randomized controlled clinical trial will be performed. First a pilot study will be carried out. Patients with carpal tunnel syndrome included on waiting surgery list of Miguel Servet Hospital will be recruited. They will be randomized into a control group (staying in waiting list and performing healthcare standard) and into an experimental group (3 sessions of 45 min of diacutaneous fibrolysis and homebased treatment). Different outcomes will be assessed at pre-treatment, at the end of treatment, 3 and 6 months later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multimodal Conservative Treatment
Arm Type
Experimental
Arm Title
Standard healthcare.
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Multimodal conservative treatment
Intervention Description
15 min of Pain education + 20 min of Specific mobilization of the forearm musculature, pronator teres, tendons of the palmar flexors of the wrist and fingers, transverse carpal ligament and palmar fascia through manual mobilization assisted by Diacutaneous Fibrolysis technique + 10min of self-management and explanation of home-based exercise.
3 sessions of 45 minutes will be taken to perform this protocol and the patient will be shown a self-treatment to be performed 3-5 times a day. The protocol will be carried out over 3 weeks (1 session per week).
Primary Outcome Measure Information:
Title
Change in nocturnal symptoms intensity (VAS)
Description
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (nocturnal symptoms) orientated from the left (worst) to the right (best). Nocturnal sumptoms were measured in the last 3 days.
Time Frame
Change between baseline, post-treatment, 3 months after, 6 months after
Title
Change in pain intensity (VAS)
Description
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best). Pain was measured in the last 3 days and currently.
Time Frame
Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Title
Change in paresthesia intensity (VAS)
Description
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (paresthesia) orientated from the left (worst) to the right (best). Paresthesia was measured in the last 3 days and currently.
Time Frame
Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Title
Change in BCTQ
Description
The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome.
Time Frame
Change between baseline, post-treatment, 3 months after, 6 months after
Title
Change in DASH questionnaire
Description
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Time Frame
Change between baseline, post-treatment, 3 months after, 6 months after
Secondary Outcome Measure Information:
Title
Change in NRS
Description
Change between baseline, post-treatment, 3 months after, 6 months after
Time Frame
The Numeric Rating Scale is a one-dimensional measure of symptoms intensity in adults. In our study, it was used to quantify the intensity of other symptoms present. It is a segmented numeric version of the visual analog scale (VAS) in which a respondent
Title
Change in Katz's Diagram
Description
Katz hand diagram is a drawing made by a patient of symptoms such as numbness, tingling, or pain affecting the hand and fingers. The drawing is a useful means of eliciting symptoms that suggest carpal tunnel syndrome.
Time Frame
Change between baseline, post-treatment, 3 months after, 6 months after
Title
Change in MOS Sleep Scale
Description
The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache.
Time Frame
Change between baseline, post-treatment, 3 months after, 6 months after
Title
Change in SF-36
Description
The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health.
Time Frame
Change between baseline, post-treatment, 3 months after, 6 months after
Title
Change in TSK
Description
The Tampa Scale of Kinesiophobia (TSK) is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
Time Frame
Change between baseline, post-treatment, 3 months after, 6 months after
Title
Change in ULTT
Description
The Upper Limb Tension Test is performed to assess mechanosensitivity of median nerve. Range of movement, symptom's location, symptoms response and structural differentiation were assessed.
Time Frame
Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Title
Change in Strength
Description
Pinch and grip strength were assessed by a manual dynamometer to evaluate forearm, hand and fingers muscle strength.
Time Frame
Change between baseline, post-treatment, 3 months after, 6 months after
Title
Change in SWMT
Description
The Semmes-Weinstein monofilament test (SWMT) is a clinical widely used test to quantify the sensibility in patients with Carpal Tunnel Syndrome (CTS).
Time Frame
Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Title
Change in Neuropen
Description
The Neuropen combines an interchangeable 10 g monofilament for cutaneous pressure assessment, and a calibrated sterile Neurotip for assessing pain sensation.
Time Frame
Change between baseline, post-treatment, 3 months after, 6 months after
Title
Change in PGI-I
Description
The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale).
Time Frame
Change between post-treatment, 3 months after, 6 months after
Other Pre-specified Outcome Measures:
Title
NCV
Description
Neural conduction velocity (NCV) test is used to assess nerve damage and dysfunction. It allows classification of the severity of the patient's dysfunction on mild, moderate or severe.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
Have been diagnosed with Carpal Tunnel Syndrome (CTS) after the electrophysiological test at the neurophysiology service of the Miguel Servet Hospital in Zaragoza and be on the waiting list for CTS surgery.
Have experienced symptoms for more than two months.
Have sufficient comprehension and communication skills to communicate their symptoms and to fill in the questionnaires.
Ability to maintain supine and lateral decubitus without causing symptoms or altering the patient's condition.
Accept and give consent to participate voluntarily in the study.
Exclusion:
Previous carpal tunnel surgery on the same limb.
History of trauma on the upper limb which CTS may be associated, other musculoskeletal or neurological pathologies affecting the upper limb (e.g., cervical radiculopathy).
Pregnancy, due to the influence of fluid retention in the cause of CTS, remitting spontaneously after childbirth, breastfeeding or up to 3 years after these episodes.
Present physical contraindications (red flags) in general that contraindicate physical treatment such as: trauma, malignancy, inflammation, infection, fever... or psychological contraindications (yellow flags) that may have a marked effect on the results of treatment.
Present specific physical contraindications that contraindicate diacutaneous fibrolysis treatment, such as ulcerations and skin alterations.
Have specific contraindications that contraindicate surgical intervention such as taking anticoagulants or antiplatelet agents.
Having received a steroid injection in the previous 6 months or interventions on the CTS in the previous 3 months.
Pending trial or litigation related to CTS.
Facility Information:
Facility Name
Faculty of Health of Science, University of Zaragoza
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
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Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery.
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