Back to resultsComparative Effects of Two Conservative Treatments in Teres Major in Handball Athletes With Shoulder Pain
Primary Purpose
Shoulder Pain, Dry Needling, Diacutaneous Fibrolysis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diacutaneous Fibrolysis
Dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain
Eligibility Criteria
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
Sites / Locations
- Sandra Jiménez Jiménez-del-Barrio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diacutaneous Fibrolysis
Dry needling
Arm Description
Diacutaneous Fibrolysis in the teres major muscle
Dry needling based on fast-in fast-out technique in the teres major muscle
Outcomes
Primary Outcome Measures
muscle stiffness
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
muscle stiffness
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
muscle stiffness
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
Secondary Outcome Measures
Pain intensity
the examiners assess the pain intensity using a visual analoigue scale
Pain intensity
the examiners assess the pain intensity using a visual analoigue scale
Pain intensity
the examiners assess the pain intensity using a visual analoigue scale
Range of motion
the examiners assess the shoulder range of motion with an universal goniometer
Range of motion
the examiners assess the shoulder range of motion with an universal goniometer
Range of motion
the examiners assess the shoulder range of motion with an universal goniometer
Extensibility
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
Extensibility
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
Extensibility
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
Full Information
NCT ID
NCT05080439
First Posted
September 2, 2021
Last Updated
August 26, 2023
Sponsor
Universidad de Zaragoza
1. Study Identification
Unique Protocol Identification Number
NCT05080439
Brief Title
Comparative Effects of Two Conservative Treatments in Teres Major in Handball Athletes With Shoulder Pain
Official Title
Comparative Effects of Two Conservative Treatments in Teres Major in Handball Athletes With Shoulder Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Dry Needling, Diacutaneous Fibrolysis, Athletic Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diacutaneous Fibrolysis
Arm Type
Experimental
Arm Description
Diacutaneous Fibrolysis in the teres major muscle
Arm Title
Dry needling
Arm Type
Experimental
Arm Description
Dry needling based on fast-in fast-out technique in the teres major muscle
Intervention Type
Other
Intervention Name(s)
Diacutaneous Fibrolysis
Intervention Description
Application of diacutaneous fibrolysis in teres major
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Dry needling based on fast-in fast-out technique in the teresa major muscle
Primary Outcome Measure Information:
Title
muscle stiffness
Description
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
Time Frame
baseline
Title
muscle stiffness
Description
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
Time Frame
After treatment immediately "1 hour"
Title
muscle stiffness
Description
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
Time Frame
After treatment, one week follow-up
Secondary Outcome Measure Information:
Title
Pain intensity
Description
the examiners assess the pain intensity using a visual analoigue scale
Time Frame
Baseline
Title
Pain intensity
Description
the examiners assess the pain intensity using a visual analoigue scale
Time Frame
After treatment immediately "1 hour"
Title
Pain intensity
Description
the examiners assess the pain intensity using a visual analoigue scale
Time Frame
After treatment, "one week follow-up"
Title
Range of motion
Description
the examiners assess the shoulder range of motion with an universal goniometer
Time Frame
Baseline
Title
Range of motion
Description
the examiners assess the shoulder range of motion with an universal goniometer
Time Frame
After treatment immediately "1 hour"
Title
Range of motion
Description
the examiners assess the shoulder range of motion with an universal goniometer
Time Frame
After treatment, "one week follow-up"
Title
Extensibility
Description
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
Time Frame
Baseline
Title
Extensibility
Description
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
Time Frame
After treatment immediately "1 hour"
Title
Extensibility
Description
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
Time Frame
After treatment, "one week follow-up"
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Ceballos Laita, PhD
Organizational Affiliation
University of Valladolid
Official's Role
Study Director
Facility Information:
Facility Name
Sandra Jiménez Jiménez-del-Barrio
City
Soria
ZIP/Postal Code
42004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Effects of Two Conservative Treatments in Teres Major in Handball Athletes With Shoulder Pain
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