- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07316946
Effects of Neuromuscular Taping on Shoulder Pain and Function in Pitchers: A Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Soria
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Soria, Soria, Spain, 42004
- Faculty of Health Sciences
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Contact:
- Sandra Jiménez del Barrio, Phd
- Phone Number: 975129166
- Email: sandra.jimenez.barrio@uva.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age over 18 years
- compete in a sport that involves overhead movement patterns
- train at least 2 hours per week
- shoulder pain lasting more than six weeks
- shoulder pain related to sports activity
- understand Spanish fluently enough to complete the questionnaire assessment.
Exclusion Criteria:
- presence of red flags that could suggest fractures, dislocations, or complete tendon ruptures, among others
- neurological pathologies
- other severe pathologies such as inflammatory arthritis, frozen shoulder
- having received corticosteroid injections or physiotherapy treatment in the last six months
- presence of previous surgeries
- pregnancy
- cognitive deficits that could limit the comprehension of the questionnaires or the physical evaluation
- skin problems that would be a contraindication for any type of bandage.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo group
The placebo group will receive the same bandage, with the same strip arrangement, but without any tension (0%) applied to any of the strips.
Furthermore, participants will not receive any instructions for muscle activation during application.
This placebo technique has been used in previous studies, supporting its methodological validity.
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The placebo group will receive the same taping, with an identical arrangement of the strips, but without applying any tension (0%) to them.
In addition, participants will not receive any instructions regarding muscle activation during the application.
This placebo taping model has been used in previous studies, supporting its methodological validity.
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Experimental: Experimental group
The experimental group will receive neuromuscular taping with kinesiology tape, consisting of two longitudinal strips applied along the lower trapezius muscle, with a tension close to 100% of the tape's elastic capacity. During application, the participant will be asked to activate the scapular depressor and retractor muscles. Additionally, two more longitudinal strips will be applied from the anterior portion of the humeral head towards the scapular spine, also with a tension close to 100%. During this application, the participant will be asked to activate the rotator cuff by applying a posteroanterior push to the humeral head. |
The experimental group will receive a multilayer neuromuscular taping application using kinesiotape, consisting of the placement of two longitudinal strips in the direction of the lower trapezius, applied with tension close to 100% of the tape's elastic capacity. During the application, participants will be asked to activate the scapular depressor and retractor muscles. Additionally, two other longitudinal strips will be applied from the anterior portion of the humeral head toward the scapular spine, also with tension close to 100%. During this application, participants will be asked to activate the rotator cuff through a posteroanterior push of the humeral head. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Actual Pain Intensity
Time Frame: Baseline, after 30 minutes of the intervention and 72 hours after intervencion
|
Pain intensity will be assessed using a 10-cm visual analog scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants will be asked to rate the intensity of pain experienced at the time of measurement
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Baseline, after 30 minutes of the intervention and 72 hours after intervencion
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Pain Intensity during the arm elevation
Time Frame: Baseline, 30 minutes after intervention and 72 hours after intervention
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Pain intensity will be assessed using a 10-cm visual analog scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants will be asked to rate the intensity of pain experienced during arm elevation.
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Baseline, 30 minutes after intervention and 72 hours after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Static Scapular Position
Time Frame: Baseline, 30 minutes after intervention and 72 hours after intervention
|
Scapular position will be measured using an anterior/posterior scale.
This static position will be recorded while standing, using a digital clinometer installed on a smartphone (Clinometer app).
The inclinometer will be positioned directly over the scapular spine in the direction of the infraglenoid fossa.
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Baseline, 30 minutes after intervention and 72 hours after intervention
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Range of Motion
Time Frame: Baseline, 30 minutes after intervention and 72 hours after intervention
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Pain-free ROM during shoulder flexion, adduction, internal rotation, and external rotation will be measured following the protocol described by Shin et al.Participants will be instructed to flex the affected arm as far as possible, keeping the thumb pointing toward the ceiling.
For adduction measurement, the patient will be placed in the side-lying position, and the evaluator will manually stabilize the scapula against the patient's thorax, allowing the arm to hang horizontally in adduction.
For internal and external rotation, participants will be positioned supine with the shoulder abducted to 90°, the elbow flexed to 90°, and the forearm in a neutral position.
A rolled towel will be placed under the humerus to maintain shoulder alignment.
Participants will be asked to rotate their arm until pain onset or until scapular movement is observed.
Three attempts of each movement will be recorded, and the mean range of motion (ROM) will be used for statistical analysis.
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Baseline, 30 minutes after intervention and 72 hours after intervention
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Functional Capacity
Time Frame: Baseline, 30 minutes after intervention and 72 hours after intervention
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Functional capacity will be assessed using the SPADI questionnaire.
The SPADI is a patient-reported outcome measure designed to assess shoulder pain and functional disability.
It consists of 13 items divided into two domains: pain and disability.
The total score will be calculated by summing both domains and converting the result to a scale of 0 to 100, where higher scores indicate greater pain and disability.
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Baseline, 30 minutes after intervention and 72 hours after intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REF CEIm
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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