An interventional study of Kinesio 12 inch Tape and Kinesio 4 inch Tape in Carpal Tunnel Syndrome, Susceptibility to, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Loma Linda University · Not applicable, Interventional, and Other
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.
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.
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's enrollment of 44 is below the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
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Exclusion Criteria:
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
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
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
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 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.
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.
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.
Time frame: 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.
Time frame: 3 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 3-weeks
| Milestone | Kinesio Tape | Standard of Care | Control Group |
|---|---|---|---|
| Started | 15 | 16 | 13 |
| Completed | 15 | 15 | 12 |
| Not completed | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 |
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.
| score on a scale | Kinesio Tape | Standard of Care | Control Group |
|---|---|---|---|
| Forearm | 0.01 (0 to 7) | .17 (0 to 7) | .30 (0 to 7) |
| Wrist | .005 (0 to 8) | .11 (0 to 8) | .43 (0 to 9) |
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.
| score on a scale | Kinesio Tape | Standard of Care | Control Group |
|---|---|---|---|
| Forearm | 18.64 ± 3.88 | 12.8 ± 4.12 | 15.2 ± 4.45 |
| Wrist | 21.4 ± 4.65 | 32.6 ± 4.96 | 24.2 ± 5.3 |
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.
| lbs | Kinesio Tape | Standard of Care | Control Group |
|---|---|---|---|
| Grip | 55.47 ± 3.7 | 64.8 ± 4.0 | 52.7 ± 4.3 |
| pinch | 12.2 ± .95 | 12.4 ± .95 | 11.8 ± 1.1 |
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.
| score on a scale | Kinesio Tape | Standard of Care | Control Group |
|---|---|---|---|
| Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS) | 1.9 ± .04 | 2.0 ± .04 | 2.0 ± .04 |
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.
| score on a scale | Kinesio Tape | Standard of Care | Control Group |
|---|---|---|---|
| Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS) | 1.5 ± .12 | 1.8 ± .13 | 1.7 ± .14 |
Collected over 3-weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kinesio Tape | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Control Group | 0/15 (0%) | 0/15 (0%) | 0/12 (0%) |
| Standard of Care | 0/12 (0%) | 0/12 (0%) | 0/15 (0%) |
Baseline randomized participants (n = 44) and baseline wrists as the unit of measure was (n = 68). A percentage of participants had bi-lateral symptomatic wrists. Analyzed randomized participants (n = 42) and analyzed wrists (n = 66). Two (2) participants voluntarily withdrew.
| Age, Continuous(years) | Kinesio Tape | Standard of Care | Control Group | Total |
|---|---|---|---|---|
| Median | 28 (23 to 67) | 28 (21 to 57) | 45 (23 to 76) | 29.5 (21 to 76) |
| Sex: Female, Male(Participants) | Kinesio Tape | Standard of Care | Control Group | Total |
|---|---|---|---|---|
| Female | 13 | 14 | 11 | 38 |
| Male | 2 | 1 | 1 | 4 |
| Race/Ethnicity, Customized(Participants) | Kinesio Tape | Standard of Care | Control Group | Total |
|---|---|---|---|---|
| African American | 0 | 0 | 1 | 1 |
| Asian | 4 | 3 | 2 | 9 |
| Caucasian or White | 7 | 8 | 7 | 22 |
| Latino/Hispanic | 4 | 2 | 1 | 7 |
| Non-Hispanic | 0 | 0 | 1 | 1 |
| Mixed | 0 | 2 | 0 | 2 |
| Region of Enrollment(participants) | Kinesio Tape | Standard of Care | Control Group | Total |
|---|---|---|---|---|
| United States | 15 | 15 | 12 | 42 |
PDFs hosted by the registry, ClinicalTrials.gov.
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