NCT02374073

Brief Summary

Purpose: Subacromial impingement syndrome is the most common shoulder condition. Myofascial trigger points in teres major muscle can be associated with this syndrome. The investigators objective is to find out if adding manual therapy specifically for teres major trigger points can produce better results in these patients. Method: A randomized controlled pilot study was carried out. Fifty people were randomly assigned to one of two groups: intervention group or control group. Both groups received a protocolized physical therapy treatment while the intervention group additionally received manual therapy for teres major trigger points.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

February 12, 2015

Last Update Submit

February 26, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity (visual analogue scale)

    Using a Visual analogue scale

    Change from baseline to 3 weeks

Secondary Outcomes (2)

  • Change in Function (Abbreviated Constant-Murley score)

    Change from baseline to 3 weeks

  • Change in Active Range of Motion

    Change from baseline to 3 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Treated with protocolized physiotherapy and functional massage

Other: Functional MassageOther: Protocolized physiotherapy

Control group

EXPERIMENTAL

Treated with protocolized physiotherapy

Other: Protocolized physiotherapy

Interventions

The functional massage is a manual therapy technique, indicated in cases of painful muscle tightness that combines a rhythmical and non painful passive joint mobilization in the direction of muscle stretching together with compression/decompression of the muscle to be treated.

Intervention group

therapeutic exercises, analgesic electrotherapy and cryotherapy

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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:

  • Presence of wounds or cutaneous alterations in the shoulder region
  • Previous surgery in the shoulder
  • Presence of acute inflammatory process in the shoulder (\< 7 days),
  • Being involved in litigation or compensation processes
  • Not having a domain of the language that could make the informed consent not understandable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

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 12, 2015

First Posted

February 27, 2015

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

February 27, 2015

Record last verified: 2015-02