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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03360344
Other study ID # 5170437
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2018
Est. completion date October 23, 2018

Study information

Verified date September 2020
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date October 23, 2018
Est. primary completion date October 23, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Kinesio 12 inch Tape
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.
Kinesio 4 inch Tape
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.
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.

Locations

Country Name City State
United States Loma Linda University Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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