Non-surgical Intervention for Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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This randomized controlled trial graduate student research study will explore the effect of non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel syndrome, and forearm wrist hand pain.

Detailed Description
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This randomized controlled trial graduate student research study will explore the effect of non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel syndrome, and forearm wrist hand pain. Little evidence exists for an effective non-surgical intervention. Semi-structured interviews will be conducted to explore changes in occupational performance and compliance in order to understand if Kinesio Tape contributed to results and if so, how the participants perceived the interventions.

Official Title
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Effects on Occupational Performance Through Dorsal Application of Kinesio Tape for Musculoskeletal Disorder - Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome, Susceptibility to

Intervention / Treatment
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* Device: Kinesio 12 inch Tape
* Device: Kinesio 4 inch Tape
* Device: Cock up Splint and Lumbrical exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults > 18 years of age Fluent in English Report signs and symptoms of carpal tunnel syndrome Pain, numbness, and tingling of the forearm, wrist, or hand, which worsen at night Demonstrate positive Phalen's Test or Tinel's Test of the affected extremity Exclusion Criteria: Currently receiving treatment for carpal tunnel syndrome History of surgical carpal tunnel release Pregnant Diabetes not controlled by medication Radiculopathy ie: cervical radiculopathy, diabetic radiculopathy Thoracic outlet syndrome Allergy to adhesives or compromised skin integrity Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesio Tape<br>Dorsal application of Kinesio Tape to the affected extremity: Approximately 12 inches of Kinesio tape will be applied from the musculotendinous junction of the participant's forearm over digits 1 and 5. Two - 2 inch strips of Kinesio Tape will be applied to the participant's wrists over the volar and dorsal aspects. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application by the researchers four times during the course of the study. A tape removal form will be provided should the participants want to remove it prior to the next visit. | Device: Kinesio 12 inch Tape<br>* Kinesio Tape approximately 12-inch strip will be applied to the dorsal surface of the forearm of the affected side for three-day increments over three weeks of the study.<br>|
| Sham Comparator: Control group<br>Approximately 4 inch strip of Kinesio Tape will be applied to the scapular spine of the same side as the affected extremity. The Kinesio Tape will remain in place for three days, with the participants returning for skin check by the researchers and re-application four times during the course of the study by the researcher. A tape removal form will be provided should the participants want to remove it prior to the next visit. | Device: Kinesio 4 inch Tape<br>* Kinesio Tape for the control group will be a 4 inch Kinesio Tape applied to the scapular spine for three day increments over three weeks of the study.<br>|
| Active Comparator: Standard of Care<br>Currently, the standard of care is a general cock-up splint and lumbrical exercises. A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants. | Device: Cock up Splint and Lumbrical exercises<br>* A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Pain Rating Scale (NRS Pain) | Numerical Pain Rating Scale (NRS Pain) involves patient circling a number from 0-10 with 0 meaning no pain and 5 moderate pain, and 10 is worst possible pain. The NRS is a segmented numeric scale, which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. Higher scores indicate greater pain intensity. | change between baseline and 3 weeks | 
| Visual Analog Scale for Pain (VAS Pain) | The Visual Analogue Scale (VAS) is unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The VAS measures participants perception of pain on a continuous scale. Individuals place a mark on a 10cm-long line. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. These are measured every 3 days for 3 weeks from baseline in the forearm, wrist and fingers. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip Strength and Pinch Strength | Grip strength is measured by Jamar Dynamometer hydraulic gauge following standard protocol. A Jamar hydraulic pinch meter gauge is used to measure finger strength in the following positions: Lateral pinch, pad to pad, and 3 Jaw-chuck pinch positions are used. Grip and pinch strength will be measured every 3 days for 3 weeks from baseline. | change between baseline and 3 weeks | 
| Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS) | The Boston Carpal Tunnel Questionnaire (BCTQ SS) is a standardised, patient-based outcome measure of symptom severity in patients with carpal tunnel syndrome. The questionnaire has 11 questions and uses a five-point rating scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. It is measured every 3 days for 3 weeks from baseline. | change between baseline and 3 weeks | 
| Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS) | The Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS) is self report 8-item questionnarie on functional activities for individuals with carpal tunnel, which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. It is measured every 3 days for 3 weeks from baseline. | 3-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carpal tunnel syndrome, pain, numbness, kinesio tape