- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05080439
Comparative Effects of Two Conservative Treatments in Teres Major in Handball Athletes With Shoulder Pain
August 26, 2023 updated by: Sandra Jiménez, Universidad de Zaragoza
The aim of the study is to investigate the effects of the dry needling technique and diacutaneous fibrolysis technique in teres major muscles on pain, range of motion, strength extensibility and muscular properties of the soft tissues of the shoulder in athletes with shoulder pain.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Soria, Spain, 42004
- Sandra Jiménez Jiménez-del-Barrio
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Athletes with Shoulder pain
- Glenohumeral internal rotation deficit
- Presence of active MTrP in the teres major muscle
Exclusion Criteria:
- Previous surgery in the upper limb
- Previous physiotherapy treatments in the shoulder
- Dry needling contraindications
- Previous dry needling experience to mantain the blinding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diacutaneous Fibrolysis
Diacutaneous Fibrolysis in the teres major muscle
|
Application of diacutaneous fibrolysis in teres major
|
Experimental: Dry needling
Dry needling based on fast-in fast-out technique in the teres major muscle
|
Dry needling based on fast-in fast-out technique in the teresa major muscle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle stiffness
Time Frame: baseline
|
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
|
baseline
|
muscle stiffness
Time Frame: After treatment immediately "1 hour"
|
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
|
After treatment immediately "1 hour"
|
muscle stiffness
Time Frame: After treatment, one week follow-up
|
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
|
After treatment, one week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Baseline
|
the examiners assess the pain intensity using a visual analoigue scale
|
Baseline
|
Pain intensity
Time Frame: After treatment immediately "1 hour"
|
the examiners assess the pain intensity using a visual analoigue scale
|
After treatment immediately "1 hour"
|
Pain intensity
Time Frame: After treatment, "one week follow-up"
|
the examiners assess the pain intensity using a visual analoigue scale
|
After treatment, "one week follow-up"
|
Range of motion
Time Frame: Baseline
|
the examiners assess the shoulder range of motion with an universal goniometer
|
Baseline
|
Range of motion
Time Frame: After treatment immediately "1 hour"
|
the examiners assess the shoulder range of motion with an universal goniometer
|
After treatment immediately "1 hour"
|
Range of motion
Time Frame: After treatment, "one week follow-up"
|
the examiners assess the shoulder range of motion with an universal goniometer
|
After treatment, "one week follow-up"
|
Extensibility
Time Frame: Baseline
|
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
|
Baseline
|
Extensibility
Time Frame: After treatment immediately "1 hour"
|
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
|
After treatment immediately "1 hour"
|
Extensibility
Time Frame: After treatment, "one week follow-up"
|
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
|
After treatment, "one week follow-up"
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Luis Ceballos Laita, PhD, University of Valladolid
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2021
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
September 2, 2021
First Submitted That Met QC Criteria
October 4, 2021
First Posted (Actual)
October 15, 2021
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 26, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of Valladolid.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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