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Teres Major Muscle and Subacromial Impingement Syndrome

Primary Purpose

Trigger Points in Teres Major Muscle, Subacromial Impingement Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diacutaneous Fibrolysis
Trigger Point Pressure Release
Protocolized physiotherapy
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Points in Teres Major Muscle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Catalan Health Institut. Sant Ildefons Rehabilitation ServiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Fibrolysis Group

Pressure Group

Control Group

Arm Description

Actual Diacutaneous Fibrolysis and protocolized physiotherapy

Trigger Point Pressure Release and protocolized physiotherapy

Protocolized physiotherapy

Outcomes

Primary Outcome Measures

Change in Pain intensity (Using a VAS)
Using a VAS
Change in Functional capacity (Abbreviated Constant-Murley score)
Abbreviated Constant-Murley score

Secondary Outcome Measures

Change in Active Range of Motion
Flexion, extension, abduction, external rotation and internal rotation
Patient perception of change (Global Rating of Change scale)
Global Rating of Change scale

Full Information

First Posted
February 10, 2015
Last Updated
February 23, 2015
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT02374125
Brief Title
Teres Major Muscle and Subacromial Impingement Syndrome
Official Title
Effectiveness of Teres Major Muscle Specific Treatment in Patients Diagnosed With Subacromial Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Points in Teres Major Muscle, Subacromial Impingement Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fibrolysis Group
Arm Type
Experimental
Arm Description
Actual Diacutaneous Fibrolysis and protocolized physiotherapy
Arm Title
Pressure Group
Arm Type
Experimental
Arm Description
Trigger Point Pressure Release and protocolized physiotherapy
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Protocolized physiotherapy
Intervention Type
Device
Intervention Name(s)
Diacutaneous Fibrolysis
Intervention Description
Applied only around teres major muscle.
Intervention Type
Other
Intervention Name(s)
Trigger Point Pressure Release
Intervention Description
Applied only in teres major muscle trigger points.
Intervention Type
Other
Intervention Name(s)
Protocolized physiotherapy
Intervention Description
Exercises, TENS and cryotherapy
Primary Outcome Measure Information:
Title
Change in Pain intensity (Using a VAS)
Description
Using a VAS
Time Frame
Change from baseline to 3 weeks.
Title
Change in Functional capacity (Abbreviated Constant-Murley score)
Description
Abbreviated Constant-Murley score
Time Frame
Change from baseline to 3 weeks.
Secondary Outcome Measure Information:
Title
Change in Active Range of Motion
Description
Flexion, extension, abduction, external rotation and internal rotation
Time Frame
Change from baseline to 3 weeks.
Title
Patient perception of change (Global Rating of Change scale)
Description
Global Rating of Change scale
Time Frame
3 weeks after recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Barra
Email
martinbarra@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martín Barra
Organizational Affiliation
IDIAP JORDI GOL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catalan Health Institut. Sant Ildefons Rehabilitation Service
City
Cornellà de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08840
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martín Barra
Email
martinbarra@gmail.com

12. IPD Sharing Statement

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Teres Major Muscle and Subacromial Impingement Syndrome

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