Trial Outcomes & Findings for Non-surgical Intervention for Carpal Tunnel Syndrome (NCT NCT03360344)
NCT ID: NCT03360344
Last Updated: 2020-10-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
change between baseline and 3 weeks
Results posted on
2020-10-08
Participant Flow
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.
Unit of analysis: wrist
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15 25
|
16 20
|
13 23
|
|
Overall Study
COMPLETED
|
15 25
|
15 19
|
12 22
|
|
Overall Study
NOT COMPLETED
|
0 0
|
1 1
|
1 1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Kinesio Tape
n=25 wrists
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.
|
Standard of Care
n=19 wrists
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.
|
Control Group
n=22 wrists
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.
|
Total
n=66 wrists
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28 years
n=5 Participants • 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
|
28 years
n=7 Participants • 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
|
45 years
n=5 Participants • 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
|
29.5 years
n=4 Participants • 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
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants • Baseline randomized participants (n = 44) with baseline wrists as the unit of measure represented was (n = 68). Analyzed randomized participants (n = 42) and analyzed wrists as units of measure were (n = 66).
|
14 Participants
n=7 Participants • Baseline randomized participants (n = 44) with baseline wrists as the unit of measure represented was (n = 68). Analyzed randomized participants (n = 42) and analyzed wrists as units of measure were (n = 66).
|
11 Participants
n=5 Participants • Baseline randomized participants (n = 44) with baseline wrists as the unit of measure represented was (n = 68). Analyzed randomized participants (n = 42) and analyzed wrists as units of measure were (n = 66).
|
38 Participants
n=4 Participants • Baseline randomized participants (n = 44) with baseline wrists as the unit of measure represented was (n = 68). Analyzed randomized participants (n = 42) and analyzed wrists as units of measure were (n = 66).
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants • Baseline randomized participants (n = 44) with baseline wrists as the unit of measure represented was (n = 68). Analyzed randomized participants (n = 42) and analyzed wrists as units of measure were (n = 66).
|
1 Participants
n=7 Participants • Baseline randomized participants (n = 44) with baseline wrists as the unit of measure represented was (n = 68). Analyzed randomized participants (n = 42) and analyzed wrists as units of measure were (n = 66).
|
1 Participants
n=5 Participants • Baseline randomized participants (n = 44) with baseline wrists as the unit of measure represented was (n = 68). Analyzed randomized participants (n = 42) and analyzed wrists as units of measure were (n = 66).
|
4 Participants
n=4 Participants • Baseline randomized participants (n = 44) with baseline wrists as the unit of measure represented was (n = 68). Analyzed randomized participants (n = 42) and analyzed wrists as units of measure were (n = 66).
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
0 Participants
n=7 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
1 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
1 Participants
n=4 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
3 Participants
n=7 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
2 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
9 Participants
n=4 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
|
Race/Ethnicity, Customized
Caucasian or White
|
7 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
8 Participants
n=7 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
7 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
22 Participants
n=4 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
|
Race/Ethnicity, Customized
Latino/Hispanic
|
4 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
2 Participants
n=7 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
1 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
7 Participants
n=4 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
0 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
0 Participants
n=7 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
1 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
1 Participants
n=4 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
|
Race/Ethnicity, Customized
Mixed
|
0 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
2 Participants
n=7 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
0 Participants
n=5 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
2 Participants
n=4 Participants • Randomized participants at baseline (n = 44) with wrists as the unit of measure was (n = 68). Analyzed participants was (n = 42) and analyzed wrists (n = 66)
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants • Two participants voluntarily withdrew from the study, One from the "Standard Care" group and one from the "Control Group"
|
15 participants
n=7 Participants • Two participants voluntarily withdrew from the study, One from the "Standard Care" group and one from the "Control Group"
|
12 participants
n=5 Participants • Two participants voluntarily withdrew from the study, One from the "Standard Care" group and one from the "Control Group"
|
42 participants
n=4 Participants • Two participants voluntarily withdrew from the study, One from the "Standard Care" group and one from the "Control Group"
|
PRIMARY outcome
Timeframe: change between baseline and 3 weeksNumerical 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.
Outcome measures
| Measure |
Standard of Care
n=19 Wrists
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.
|
Control Group
n=22 Wrists
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.
|
Kinesio Tape
n=25 Wrists
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.
|
|---|---|---|---|
|
Numerical Pain Rating Scale (NRS Pain)
Forearm
|
.17 score on a scale
Interval 0.0 to 7.0
|
.30 score on a scale
Interval 0.0 to 7.0
|
0.01 score on a scale
Interval 0.0 to 7.0
|
|
Numerical Pain Rating Scale (NRS Pain)
Wrist
|
.11 score on a scale
Interval 0.0 to 8.0
|
.43 score on a scale
Interval 0.0 to 9.0
|
.005 score on a scale
Interval 0.0 to 8.0
|
PRIMARY outcome
Timeframe: 3 weeksThe 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.
Outcome measures
| Measure |
Standard of Care
n=19 Wrists
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.
|
Control Group
n=22 Wrists
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.
|
Kinesio Tape
n=25 Wrists
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.
|
|---|---|---|---|
|
Visual Analog Scale for Pain (VAS Pain)
Forearm
|
12.8 score on a scale
Standard Error 4.12
|
15.2 score on a scale
Standard Error 4.45
|
18.64 score on a scale
Standard Error 3.88
|
|
Visual Analog Scale for Pain (VAS Pain)
Wrist
|
32.6 score on a scale
Standard Error 4.96
|
24.2 score on a scale
Standard Error 5.3
|
21.4 score on a scale
Standard Error 4.65
|
SECONDARY outcome
Timeframe: change between baseline and 3 weeksGrip 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.
Outcome measures
| Measure |
Standard of Care
n=19 wrists
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.
|
Control Group
n=22 wrists
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.
|
Kinesio Tape
n=25 wrists
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.
|
|---|---|---|---|
|
Grip Strength and Pinch Strength
Grip
|
64.8 lbs
Standard Error 4.0
|
52.7 lbs
Standard Error 4.3
|
55.47 lbs
Standard Error 3.7
|
|
Grip Strength and Pinch Strength
pinch
|
12.4 lbs
Standard Error .95
|
11.8 lbs
Standard Error 1.1
|
12.2 lbs
Standard Error .95
|
SECONDARY outcome
Timeframe: change between baseline and 3 weeksThe 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.
Outcome measures
| Measure |
Standard of Care
n=19 wrists
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.
|
Control Group
n=22 wrists
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.
|
Kinesio Tape
n=25 wrists
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.
|
|---|---|---|---|
|
Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS)
|
2.0 score on a scale
Standard Error .04
|
2.0 score on a scale
Standard Error .04
|
1.9 score on a scale
Standard Error .04
|
SECONDARY outcome
Timeframe: 3-weeksThe 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.
Outcome measures
| Measure |
Standard of Care
n=19 Wrists
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.
|
Control Group
n=22 Wrists
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.
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Kinesio Tape
n=25 Wrists
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.
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Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS)
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1.8 score on a scale
Standard Error .13
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1.7 score on a scale
Standard Error .14
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1.5 score on a scale
Standard Error .12
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Adverse Events
Kinesio Tape
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place