NCT02686437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 10, 2017

Completed
Last Updated

October 31, 2018

Status Verified

December 1, 2017

Enrollment Period

1.2 years

First QC Date

February 15, 2016

Results QC Date

May 16, 2017

Last Update Submit

December 15, 2017

Conditions

Keywords

shoulder dysfunctionkinesiology taperehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Increasing Tension

EXPERIMENTAL

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

Control Tension

SHAM COMPARATOR

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

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.

Control TensionIncreasing Tension

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • tested within the first 2 to 3 therapy visits, have a diagnosis of shoulder pain, and be 18-64 years old

You may not qualify if:

  • Corticosteroid treatment within the last two weeks, post-surgical cases, and pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport and Spine Rehab

Rockville, Maryland, 20878, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jena Etnoyer-Slaski
Organization
Sport and Spine Rehab Clinical Research Foundation

Study Officials

  • Jena Slaski, MEd, ATC

    Sport and Spine Rehab Clinical Research Foundation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 19, 2016

Study Start

March 19, 2015

Primary Completion

June 8, 2016

Study Completion

August 30, 2016

Last Updated

October 31, 2018

Results First Posted

October 10, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations