Teres Major Muscle and Subacromial Impingement Syndrome

Subacromial Impingement Syndrome Clinical Trial

Official title:

Effectiveness of Teres Major Muscle Specific Treatment in Patients Diagnosed With Subacromial Impingement Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02374125
• Other study ID #: P14/033
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2015
• Last updated: February 23, 2015
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Jordi Gol i Gurina Foundation
• Contact: Martin Barra
• Email: martinbarra[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Institut Català de la Salut
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome
• Syndrome
• Trigger Points in Teres Major Muscle

Intervention

Device:
• Diacutaneous Fibrolysis
Applied only around teres major muscle.

Other:
• Trigger Point Pressure Release
Applied only in teres major muscle trigger points.
• Protocolized physiotherapy
Exercises, TENS and cryotherapy

Locations

Country	Name	City	State
Spain	Catalan Health Institut. Sant Ildefons Rehabilitation Service	Cornellà de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain intensity (Using a VAS)	Using a VAS	Change from baseline to 3 weeks.	Yes
Primary	Change in Functional capacity (Abbreviated Constant-Murley score)	Abbreviated Constant-Murley score	Change from baseline to 3 weeks.	Yes
Secondary	Change in Active Range of Motion	Flexion, extension, abduction, external rotation and internal rotation	Change from baseline to 3 weeks.	Yes
Secondary	Patient perception of change (Global Rating of Change scale)	Global Rating of Change scale	3 weeks after recruitment	Yes