Shoulder PainShoulderTBKTNCT02686437
Tension of THERABAND® Kinesiology Tape on Shoulder Pain
A study testing TheraBand Kinesiology Tape in people with Shoulder Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- TheraBand Kinesiology Tape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2015to 30 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- tested within the first 2 to 3 therapy visits, have a diagnosis of shoulder pain, and be 18-64 years old
Who cannot join
- Corticosteroid treatment within the last two weeks, post-surgical cases, and pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- TheraBand Kinesiology Tape
- Keywords
- shoulder dysfunction, kinesiology tape, rehabilitation
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraBand Kinesiology TapeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: TheraBand Kinesiology Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Assessed at baseline, 1,2,3, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start19 Mar 2015
- Primary completion8 Jun 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jena Slaski, MEd, ATC, Study director, Sport and Spine Rehab Clinical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686437
- Sponsor's protocol ID
- SSR06
- Acronym
- ShoulderTBKT
- Status last verified
- Dec 2017
- First submitted
- 15 Feb 2016
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tension of THERABAND® Kinesiology Tape on Shoulder Pain
- ClinicalTrials.gov ID
- NCT02686437
- Acronym / sponsor ID
- ShoulderTBKT / SSR06
- Conditions
- Shoulder Pain
- Keywords
- shoulder dysfunction, kinesiology tape, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- 19 Mar 2015 (actual)
- Primary completion
- 8 Jun 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Posted 10 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increasing Tension | Experimental | Other: TheraBand Kinesiology TapeThe 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 |
| Control Tension | Sham comparator | Other: TheraBand Kinesiology TapeThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- tested within the first 2 to 3 therapy visits, have a diagnosis of shoulder pain, and be 18-64 years old
Key exclusion criteria (1 listed)
- Corticosteroid treatment within the last two weeks, post-surgical cases, and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraBand Kinesiology TapeKinesiology 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. | Other | Control Tension, Increasing Tension |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jena Slaski, MEd, ATC study director
Sport and Spine Rehab Clinical Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraBand Kinesiology Tape in people with Shoulder Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Assessed at baseline, 1,2,3, and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.