- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02374125
Teres Major Muscle and Subacromial Impingement Syndrome
Effectiveness of Teres Major Muscle Specific Treatment in Patients Diagnosed With Subacromial Impingement Syndrome
There is not a clear understanding of the origin of symptoms perceived by patients with impingement of the soft tissue structures of the subacromial space. Tendinopathy, tendon rupture or other pathologies, are present in asymptomatic subjects and subjects with symptoms and structural integrity can also be found.
Patients diagnosed with subacromial impingement syndrome frequently have myofascial trigger points in the teres major muscle. Travell and Simons reported that the symptoms caused by trigger points in this muscle are similar to those experienced by patients diagnosed with impingement syndrome, but a literature search provides few results regarding relationship between subacromial impingement syndrome and presence of myofascial trigger points in the teres major muscle.
This study aims to provide evidence of the results that can be obtained with a specific approach of teres mayor muscle by two manual techniques, Trigger Point Pressure Release and Diacutaneous Fibrolysis, in subjects with subacromial impingement syndrome, a condition that still representing both a diagnostic and therapeutic challenge. Secondary objective is to compare the outcomes between both techniques to select for each patient the most appropriate to their needs and characteristics.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Barcelona
-
Cornellà de Llobregat, Barcelona, Spain, 08840
- Recruiting
- Catalan Health Institut. Sant Ildefons Rehabilitation Service
-
Contact:
- Martín Barra
- Email: martinbarra@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years and over
- Clinical diagnosis of Subacromial Impingement Syndrome.
- Detectable trigger points in teres major muscle.
- Sign informed consent form.
Exclusion Criteria:
- Diacutaneous Fibrolysis contraindications
- Previous shoulder surgery (<1year)
- Language barriers or cognitive issues that limit their ability to provide informed consent and participate in research.
- Patients with a pending litigation or court claim.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fibrolysis Group
Actual Diacutaneous Fibrolysis and protocolized physiotherapy
|
Applied only around teres major muscle.
Exercises, TENS and cryotherapy
|
|
Experimental: Pressure Group
Trigger Point Pressure Release and protocolized physiotherapy
|
Exercises, TENS and cryotherapy
Applied only in teres major muscle trigger points.
|
|
Active Comparator: Control Group
Protocolized physiotherapy
|
Exercises, TENS and cryotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain intensity (Using a VAS)
Time Frame: Change from baseline to 3 weeks.
|
Using a VAS
|
Change from baseline to 3 weeks.
|
|
Change in Functional capacity (Abbreviated Constant-Murley score)
Time Frame: Change from baseline to 3 weeks.
|
Abbreviated Constant-Murley score
|
Change from baseline to 3 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Active Range of Motion
Time Frame: Change from baseline to 3 weeks.
|
Flexion, extension, abduction, external rotation and internal rotation
|
Change from baseline to 3 weeks.
|
|
Patient perception of change (Global Rating of Change scale)
Time Frame: 3 weeks after recruitment
|
Global Rating of Change scale
|
3 weeks after recruitment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Martín Barra, IDIAP Jordi Gol
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P14/033
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