Trial Outcomes & Findings for Tension of THERABAND® Kinesiology Tape on Shoulder Pain (NCT NCT02686437)
NCT ID: NCT02686437
Last Updated: 2018-10-31
Results Overview
Rate the pain on a scale of 0 to 10, 0 being none and 10 being the worst imaginable pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Assessed at baseline, 1,2,3, and 4 weeks
Results posted on
2018-10-31
Participant Flow
Participant milestones
| Measure |
Increasing Tension
The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an "I" strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group's tape will systemically increase based on the following timelines:
Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension
TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment.
|
Control Tension
The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an "I" strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group's tape will remain at 0% tension
TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
20
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tension of THERABAND® Kinesiology Tape on Shoulder Pain
Baseline characteristics by cohort
| Measure |
Increasing Tension
n=16 Participants
The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an "I" strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group's tape will systemically increase based on the following timelines:
Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension
TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment.
|
Control Tension
n=20 Participants
The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an "I" strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group's tape will remain at 0% tension
TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.38 years
n=5 Participants
|
37.75 years
n=7 Participants
|
39.81 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline, 1,2,3, and 4 weeksPopulation: Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section
Rate the pain on a scale of 0 to 10, 0 being none and 10 being the worst imaginable pain
Outcome measures
| Measure |
Increasing Tension
n=13 Participants
The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an "I" strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group's tape will systemically increase based on the following timelines:
Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension
TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment.
|
Control Tension
n=12 Participants
The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an "I" strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group's tape will remain at 0% tension
TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Baseline Pain (T1)
|
5.458 units on a scale
Standard Error .764
|
5.115 units on a scale
Standard Error .734
|
|
Numeric Pain Rating Scale (NPRS)
1 Week Pain (T2)
|
4.708 units on a scale
Standard Error .732
|
3.808 units on a scale
Standard Error .704
|
|
Numeric Pain Rating Scale (NPRS)
2 Week Pain (T3)
|
3.458 units on a scale
Standard Error .663
|
3.115 units on a scale
Standard Error .637
|
|
Numeric Pain Rating Scale (NPRS)
3 Week Pain (T4)
|
3.392 units on a scale
Standard Error .641
|
2.923 units on a scale
Standard Error .615
|
|
Numeric Pain Rating Scale (NPRS)
4 Week Pain (T5)
|
2.833 units on a scale
Standard Error .588
|
2.269 units on a scale
Standard Error .565
|
PRIMARY outcome
Timeframe: Assessed at baseline, 1,2,3, and 4 weeksPopulation: Population analyzed based off of number of subjects who completed the study, see Overall Study Participant Flow section
The PENN is a outcome measure designed to determine the amount of disability patients are experiencing doing day to day activities. The total score is out of 100, 100 being no disability and 0 being completely disabled.
Outcome measures
| Measure |
Increasing Tension
n=13 Participants
The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an "I" strip from the vertebral border of the scapula to the lesser tubercle of the humerus. Over the course of the 4 weeks of care, the tension of the Intervention Group's tape will systemically increase based on the following timelines:
Week 1: 0% tension Week 2: 25% tension Week 3: 50% tension Week 4: 75% tension
TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment.
|
Control Tension
n=12 Participants
The kinesiology tape will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The clinician applied the tape in an "I" strip from the vertebral border of the scapula to the greater tuberosity of the humerus. Over the course of the 4 weeks of care, the tension of the Control Group's tape will remain at 0% tension
TheraBand Kinesiology Tape: Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment.
|
|---|---|---|
|
Penn Shoulder Score (PENN)
Baseline PENN (T1)
|
53.525 units on a scale
Standard Error 6.240
|
52.092 units on a scale
Standard Error 5.995
|
|
Penn Shoulder Score (PENN)
1 Week PENN (T2)
|
60.283 units on a scale
Standard Error 5.220
|
62.646 units on a scale
Standard Error 5.015
|
|
Penn Shoulder Score (PENN)
2 Week PENN (T3)
|
61.742 units on a scale
Standard Error 5.629
|
67.362 units on a scale
Standard Error 5.408
|
|
Penn Shoulder Score (PENN)
3 Week PENN (T4)
|
65.642 units on a scale
Standard Error 4.721
|
73.231 units on a scale
Standard Error 4.536
|
|
Penn Shoulder Score (PENN)
4 Week PENN (T5)
|
69.100 units on a scale
Standard Error 4.958
|
75.873 units on a scale
Standard Error 4.763
|
Adverse Events
Increasing Tension
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Tension
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
Jena Etnoyer-Slaski
Sport and Spine Rehab Clinical Research Foundation
Phone: 301-251-2777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place