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

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ClinicalTrials.gov Identifier: NCT02686437
Recruitment Status : Completed
First Posted : February 19, 2016
Results First Posted : October 10, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Sport and Spine Rehab Clinical Research Foundation

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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Other: TheraBand Kinesiology Tape Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tension of THERABAND® Kinesiology Tape on Shoulder Pain
Actual Study Start Date : March 19, 2015
Actual Primary Completion Date : June 8, 2016
Actual Study Completion Date : August 30, 2016

Arm Intervention/treatment
Experimental: 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

Other: 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.
Sham Comparator: 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
Other: 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.



Primary Outcome Measures :
  1. Numeric Pain Rating Scale (NPRS) [ Time Frame: 4 weeks ]
    Rate the pain on a scale of 0 to 10, 0 being none and 10 being the worst imaginable pain

  2. Penn Shoulder Score (PENN) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686437


Locations
United States, Maryland
Sport and Spine Rehab
Rockville, Maryland, United States, 20878
Sponsors and Collaborators
Sport and Spine Rehab Clinical Research Foundation
Investigators
Study Director: Jena Slaski, MEd, ATC Sport and Spine Rehab Clinical Research Foundation

Responsible Party: Sport and Spine Rehab Clinical Research Foundation
ClinicalTrials.gov Identifier: NCT02686437     History of Changes
Other Study ID Numbers: SSR06
First Posted: February 19, 2016    Key Record Dates
Results First Posted: October 10, 2017
Last Update Posted: October 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sport and Spine Rehab Clinical Research Foundation:
shoulder dysfunction
kinesiology tape
rehabilitation

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms