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

Mobility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833779
• Other study ID #: SSD
• Status: Completed
• Phase: N/A
• First received: July 5, 2016
• Last updated: July 14, 2016
• Start date: April 2010

Study information

• Verified date: July 2016
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Basuqe Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mobility
• Shoulder Impingement Syndrome

Intervention

Other:
• Individual exercises

• Group exercises

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The assessment of pain with a visual analogue scale.		Six Months	Yes
Primary	The mobility (joint range of motion) with a goniometer.		Six Months	Yes