Teres Major Muscle and Subacromial Impingement Syndrome

NCT02374125 | Unknown

• 1 other identifier: P14/033
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigger Points in Teres Major Muscle; Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (2)

• Change in Pain intensity (Using a VAS)

  Using a VAS

  Change from baseline to 3 weeks.

• Change in Functional capacity (Abbreviated Constant-Murley score)

  Abbreviated Constant-Murley score

  Change from baseline to 3 weeks.

Secondary Outcomes (2)

• Change in Active Range of Motion

  Change from baseline to 3 weeks.

• Patient perception of change (Global Rating of Change scale)

  3 weeks after recruitment

Study Arms (3)

Fibrolysis Group

EXPERIMENTAL

Actual Diacutaneous Fibrolysis and protocolized physiotherapy

Device: Diacutaneous Fibrolysis; Other: Protocolized physiotherapy

Pressure Group

EXPERIMENTAL

Trigger Point Pressure Release and protocolized physiotherapy

Other: Trigger Point Pressure Release; Other: Protocolized physiotherapy

Control Group

ACTIVE COMPARATOR

Protocolized physiotherapy

Other: Protocolized physiotherapy

Interventions

Diacutaneous Fibrolysis DEVICE

Applied only around teres major muscle.

Fibrolysis Group

Trigger Point Pressure Release OTHER

Applied only in teres major muscle trigger points.

Pressure Group

Protocolized physiotherapy OTHER

Exercises, TENS and cryotherapy

Control Group; Fibrolysis Group; Pressure Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and over
• Clinical diagnosis of Subacromial Impingement Syndrome.
• Detectable trigger points in teres major muscle.
• Sign informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Catalan Health Institut. Sant Ildefons Rehabilitation Service

Cornellà de Llobregat, Barcelona, 08840, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Martín Barra

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Barra

CONTACT

martinbarra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 27, 2015
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 27, 2015

Record last verified: 2015-02

Locations

ES (1)