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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: TheraBand Kinesiology Tape

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
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20878
      • Sport and Spine Rehab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessed at baseline, 1,2,3, and 4 weeks
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.	Assessed at baseline, 1,2,3, and 4 weeks

Collaborators and Investigators

• Sponsor: Sport and Spine Rehab Clinical Research Foundation
• Investigators: Study Director: Jena Slaski, MEd, ATC, Sport and Spine Rehab Clinical Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2015
• Primary Completion (Actual): June 8, 2016
• Study Completion (Actual): August 30, 2016

Study Registration Dates

• First Submitted: February 15, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: rehabilitation; shoulder dysfunction; kinesiology tape
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: SSR06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO