Shoulder Pain
Conditions
Keywords
shoulder dysfunction, kinesiology tape, rehabilitation
Brief summary
The purpose of this study is to determine the effectiveness of standard tension of Thera-Band® Kinesiological Tape (TB-KT) application versus varied tension on shoulder pain, disability, and recovery speed during an in-office rehabilitative program. A convenience sample size of 38 new patients with current shoulder pain will be recruited for this study. The outcome measures will include the Numeric Pain Rating Scale (NPRS) and the Penn Shoulder Score (PENN). After completing the initial paperwork, patients will be randomized into two groups, control (0% tension) and intervention(increasing tension). At the beginning of each week the tape will be reapplied, and pain rating will be recorded. At the conclusion of 4 weeks patients will complete the PENN.
Detailed description
The purpose of this study is to determine the effectiveness of standard tension of Thera-Band® Kinesiological Tape (TB-KT) application versus varied tension on shoulder pain, disability, and recovery speed during an in-office rehabilitative program. A convenience sample size of 38 new patients with current shoulder pain will be recruited for this study. Patients must be tested within the first 2 to 3 therapy visits, have a diagnosis of shoulder pain, be 18-64 years old, no corticosteroid treatment within the last two weeks, post-surgical cases will be excluded, and patients may not be pregnant. Upon agreeing to the study, patients will sign an informed consent, complete a demographics questionnaire, and complete specific outcome measure assessments. The outcome measures will include the Numeric Pain Rating Scale (NPRS) and the Penn Shoulder Score (PENN). After completing the initial paperwork, patients will be randomized into two groups, control and intervention. The Control group will receive standard FUNHAB® in-office care in addition to standard TB-KT taping technique. The Intervention group will receive standard FUNHAB® in-office care plus varying tension application of TB-KT. The TB-KT will be applied to the shoulder complex to influence proper activation of the rotator cuff muscles, specifically the supraspinatus and infraspinatus. The tape will be applied 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, the tension of the tape will systemically increase. At the beginning of each week the tape will be reapplied, and pain rating will be recorded. At the conclusion of 4 weeks patients will complete the PENN.
Interventions
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.
Sponsors
Sport and Spine Rehab Clinical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* tested within the first 2 to 3 therapy visits, have a diagnosis of shoulder pain, and be 18-64 years old
Exclusion criteria
* Corticosteroid treatment within the last two weeks, post-surgical cases, and pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | Assessed at baseline, 1,2,3, and 4 weeks | Rate the pain on a scale of 0 to 10, 0 being none and 10 being the worst imaginable pain |
| Penn Shoulder Score (PENN) | Assessed at baseline, 1,2,3, and 4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 20 |
| Total | 36 |
Baseline characteristics
| Characteristic | Increasing Tension | Control Tension | Total |
|---|---|---|---|
| Age, Continuous | 42.38 years | 37.75 years | 39.81 years |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 20 |
| other Total, other adverse events | 0 / 16 | 0 / 20 |
| serious Total, serious adverse events | 0 / 16 | 0 / 20 |
Outcome results
Primary
Numeric Pain Rating Scale (NPRS)
Rate the pain on a scale of 0 to 10, 0 being none and 10 being the worst imaginable pain
Time frame: Assessed at baseline, 1,2,3, and 4 weeks
Population: Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Increasing Tension | Numeric Pain Rating Scale (NPRS) | 1 Week Pain (T2) | 4.708 units on a scale | Standard Error 0.732 |
| Increasing Tension | Numeric Pain Rating Scale (NPRS) | 3 Week Pain (T4) | 3.392 units on a scale | Standard Error 0.641 |
| Increasing Tension | Numeric Pain Rating Scale (NPRS) | 2 Week Pain (T3) | 3.458 units on a scale | Standard Error 0.663 |
| Increasing Tension | Numeric Pain Rating Scale (NPRS) | 4 Week Pain (T5) | 2.833 units on a scale | Standard Error 0.588 |
| Increasing Tension | Numeric Pain Rating Scale (NPRS) | Baseline Pain (T1) | 5.458 units on a scale | Standard Error 0.764 |
| Control Tension | Numeric Pain Rating Scale (NPRS) | 4 Week Pain (T5) | 2.269 units on a scale | Standard Error 0.565 |
| Control Tension | Numeric Pain Rating Scale (NPRS) | Baseline Pain (T1) | 5.115 units on a scale | Standard Error 0.734 |
| Control Tension | Numeric Pain Rating Scale (NPRS) | 1 Week Pain (T2) | 3.808 units on a scale | Standard Error 0.704 |
| Control Tension | Numeric Pain Rating Scale (NPRS) | 2 Week Pain (T3) | 3.115 units on a scale | Standard Error 0.637 |
| Control Tension | Numeric Pain Rating Scale (NPRS) | 3 Week Pain (T4) | 2.923 units on a scale | Standard Error 0.615 |
Primary
Penn Shoulder Score (PENN)
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.
Time frame: Assessed at baseline, 1,2,3, and 4 weeks
Population: Population analyzed based off of number of subjects who completed the study, see Overall Study Participant Flow section
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Increasing Tension | Penn Shoulder Score (PENN) | 1 Week PENN (T2) | 60.283 units on a scale | Standard Error 5.22 |
| Increasing Tension | Penn Shoulder Score (PENN) | 3 Week PENN (T4) | 65.642 units on a scale | Standard Error 4.721 |
| Increasing Tension | Penn Shoulder Score (PENN) | 2 Week PENN (T3) | 61.742 units on a scale | Standard Error 5.629 |
| Increasing Tension | Penn Shoulder Score (PENN) | 4 Week PENN (T5) | 69.100 units on a scale | Standard Error 4.958 |
| Increasing Tension | Penn Shoulder Score (PENN) | Baseline PENN (T1) | 53.525 units on a scale | Standard Error 6.24 |
| Control Tension | Penn Shoulder Score (PENN) | 4 Week PENN (T5) | 75.873 units on a scale | Standard Error 4.763 |
| Control Tension | Penn Shoulder Score (PENN) | Baseline PENN (T1) | 52.092 units on a scale | Standard Error 5.995 |
| Control Tension | Penn Shoulder Score (PENN) | 1 Week PENN (T2) | 62.646 units on a scale | Standard Error 5.015 |
| Control Tension | Penn Shoulder Score (PENN) | 2 Week PENN (T3) | 67.362 units on a scale | Standard Error 5.408 |
| Control Tension | Penn Shoulder Score (PENN) | 3 Week PENN (T4) | 73.231 units on a scale | Standard Error 4.536 |