Trial to Compare the Effectiveness of Group Versus Individual Therapy on Alternate Days in Patients With Subacromial Impingement Syndrome
1 other identifier
interventional
89
0 countries
N/A
Brief Summary
Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree about which type of exercise is most appropriate. Manual Physiotherapy combined with guided exercise is a commonly applied clinical treatment, but no proof of its effectiveness has been shown. Clinical trials comparing results of treating subacromial syndrome of the shoulder with guided self-treatment and conventional physiotherapy yielded a slightly higher improvement, basically because patients suffered from chronic tendinitis and the treatment period lasted only two weeks. That is the reason why the investigators propose a long-term follow-up study and a more complete assessment of effectiveness of the exercise prescribed to improved this pathology. Objectives:
- Assessment of effectiveness of two different types of treatment of subacromial syndrome of the shoulder.
- Comparison of effectiveness of both treatments in order to select that one yielding better results as the one to be applied as a routine practice. Patients will be assigned one of the following treatments:
- Group 1: patients will be taught exercises in groups of six people, on a daily basis for twelve sessions.
- Group 2: patients will be taught the same exercise as Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering. A modified version of the Constant scale will be used to assess mobility and pain shoulder.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 5, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedJuly 15, 2016
July 1, 2016
3.5 years
July 5, 2016
July 14, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
The assessment of pain with a visual analogue scale.
Six Months
The mobility (joint range of motion) with a goniometer.
Six Months
Study Arms (2)
Group Therapy Exercises
ACTIVE COMPARATORPatients will be taught exercises in groups of six persons, on a daily basis for twelve sessions.
Individual Manual Therapy Exercises
ACTIVE COMPARATORPatients will be taught the same exercises as in a Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering
Interventions
Eligibility Criteria
You may qualify if:
- History of shoulder pain defined as at least 2 positive results in subacromial impingement tests.
- Self-perceived pain reported by the patient under clinical examination of the shoulder.
- A minimum of 90º mobility in flexion.
You may not qualify if:
- Luxation, a history of surgery, or evidence the current shoulder pain or other symptoms under cervical examination or other shoulder bone disease, except for acromioclavicular joint arthrosis.
- Patients were receiving other physiotherapy or rehabilitation treatments.
- Patients had been treated for SIS (subacromial impingement syndrome) with injection of anti-inflammatory or analgesic drugs in the last month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Registered physiotherapist
Study Record Dates
First Submitted
July 5, 2016
First Posted
July 14, 2016
Study Start
April 1, 2010
Primary Completion
October 1, 2013
Last Updated
July 15, 2016
Record last verified: 2016-07