Carpal Tunnel Syndrome, Susceptibility to
Conditions
Keywords
carpal tunnel syndrome, pain, numbness, kinesio tape
Brief 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.
Detailed 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.
Interventions
DEVICEKinesio 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.
DEVICEKinesio 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.
DEVICECock 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.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants do not know which group they will be randomly assigned
Intervention model description
prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale (NRS Pain) | change between baseline and 3 weeks | 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. |
| Visual Analog Scale for Pain (VAS Pain) | 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength and Pinch Strength | change between baseline and 3 weeks | 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. |
| Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS) | change between baseline and 3 weeks | 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. |
| Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS) | 3-weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Forty-four (44) participants and sixty-eight (68) wrists were enrolled in the study. Some participants had bilateral involvement whereas other participants only had one wrist that was involved.
Participants by arm
| Arm | Count |
|---|---|
| Kinesio Tape 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.
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. | 15 |
| Kinesio Tape 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.
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. | 25 |
| Standard of Care 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.
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. | 15 |
| Standard of Care 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.
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. | 19 |
| Control Group 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.
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. | 12 |
| Control Group 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.
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. | 22 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Kinesio Tape | Standard of Care | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 28 years | 28 years | 45 years | 29.5 years |
| Race/Ethnicity, Customized African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 3 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized Caucasian or White | 7 Participants | 8 Participants | 7 Participants | 22 Participants |
| Race/Ethnicity, Customized Latino/Hispanic | 4 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized Mixed | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 12 participants | 42 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 11 Participants | 38 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 12 |
| other Total, other adverse events | 0 / 15 | 0 / 12 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 12 |
Outcome results
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.
Time frame: change between baseline and 3 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kinesio Tape | Numerical Pain Rating Scale (NRS Pain) | Forearm | 0.01 score on a scale |
| Kinesio Tape | Numerical Pain Rating Scale (NRS Pain) | Wrist | .005 score on a scale |
| Standard of Care | Numerical Pain Rating Scale (NRS Pain) | Forearm | .17 score on a scale |
| Standard of Care | Numerical Pain Rating Scale (NRS Pain) | Wrist | .11 score on a scale |
| Control Group | Numerical Pain Rating Scale (NRS Pain) | Forearm | .30 score on a scale |
| Control Group | Numerical Pain Rating Scale (NRS Pain) | Wrist | .43 score on a scale |
Comparison: statistical analysis for wristp-value: 0.48Wilcoxan signed Rank
Comparison: statistical analysis for forearmp-value: 0.99Wilcoxan Signed Rank
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.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kinesio Tape | Visual Analog Scale for Pain (VAS Pain) | Forearm | 18.64 score on a scale | Standard Error 3.88 |
| Kinesio Tape | Visual Analog Scale for Pain (VAS Pain) | Wrist | 21.4 score on a scale | Standard Error 4.65 |
| Standard of Care | Visual Analog Scale for Pain (VAS Pain) | Forearm | 12.8 score on a scale | Standard Error 4.12 |
| Standard of Care | Visual Analog Scale for Pain (VAS Pain) | Wrist | 32.6 score on a scale | Standard Error 4.96 |
| Control Group | Visual Analog Scale for Pain (VAS Pain) | Forearm | 15.2 score on a scale | Standard Error 4.45 |
| Control Group | Visual Analog Scale for Pain (VAS Pain) | Wrist | 24.2 score on a scale | Standard Error 5.3 |
Comparison: statistical analysis for forearmp-value: 0.001ANOVA
Comparison: statistical analysis for wristp-value: 0.001ANOVA
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.
Time frame: 3-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kinesio Tape | Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS) | 1.5 score on a scale | Standard Error 0.12 |
| Standard of Care | Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS) | 1.8 score on a scale | Standard Error 0.13 |
| Control Group | Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS) | 1.7 score on a scale | Standard Error 0.14 |
p-value: 0.001Kruskal-Wallis
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.
Time frame: change between baseline and 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kinesio Tape | Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS) | 1.9 score on a scale | Standard Error 0.04 |
| Standard of Care | Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS) | 2.0 score on a scale | Standard Error 0.04 |
| Control Group | Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS) | 2.0 score on a scale | Standard Error 0.04 |
p-value: 0.01ANCOVA
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.
Time frame: change between baseline and 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kinesio Tape | Grip Strength and Pinch Strength | Grip | 55.47 lbs | Standard Error 3.7 |
| Kinesio Tape | Grip Strength and Pinch Strength | pinch | 12.2 lbs | Standard Error 0.95 |
| Standard of Care | Grip Strength and Pinch Strength | Grip | 64.8 lbs | Standard Error 4 |
| Standard of Care | Grip Strength and Pinch Strength | pinch | 12.4 lbs | Standard Error 0.95 |
| Control Group | Grip Strength and Pinch Strength | Grip | 52.7 lbs | Standard Error 4.3 |
| Control Group | Grip Strength and Pinch Strength | pinch | 11.8 lbs | Standard Error 1.1 |
p-value: 0.06Wilcoxon (Mann-Whitney)