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Tension of THERABAND® Kinesiology Tape on Shoulder Pain (ShoulderTBKT)

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TheraBand Kinesiology Tape
Sponsored by
Sport and Spine Rehab Clinical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring shoulder dysfunction, kinesiology tape, rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sport and Spine Rehab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Increasing Tension

Control Tension

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2016
Last Updated
December 15, 2017
Sponsor
Sport and Spine Rehab Clinical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02686437
Brief Title
Tension of THERABAND® Kinesiology Tape on Shoulder Pain
Acronym
ShoulderTBKT
Official Title
Tension of THERABAND® Kinesiology Tape on Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 19, 2015 (Actual)
Primary Completion Date
June 8, 2016 (Actual)
Study Completion Date
August 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sport and Spine Rehab Clinical Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
shoulder dysfunction, kinesiology tape, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Increasing Tension
Arm Type
Experimental
Arm Description
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
Arm Title
Control Tension
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
TheraBand Kinesiology Tape
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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
Title
Penn Shoulder Score (PENN)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jena Slaski, MEd, ATC
Organizational Affiliation
Sport and Spine Rehab Clinical Research Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Sport and Spine Rehab
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20878
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tension of THERABAND® Kinesiology Tape on Shoulder Pain

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