Trial to Compare the Effectiveness of Group Versus Individual Therapy on Alternate Days in Patients With Subacromial Impingement Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Mobility
• Intervention / Treatment: Other: Group exercises; Other: Individual exercises

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Therapy Exercises; Patients will be taught exercises in groups of six persons, on a daily basis for twelve sessions.	Other: Group exercises
Active Comparator: Individual Manual Therapy Exercises; Patients will be taught the same exercises as in a Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering	Other: Individual exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The assessment of pain with a visual analogue scale.	Six Months
The mobility (joint range of motion) with a goniometer.	Six Months

Collaborators and Investigators

• Sponsor: Basque Health Service

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Estimate): July 15, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: SSD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No