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Effectiveness of Physiotherapy for Chronic Shoulder Pain

Primary Purpose

Shoulder Pain

Status

Completed

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

Physiotherapy program

Placebo physiotherapy treatment

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring physiotherapy, exercise, manual therapy, shoulder pain, rotator cuff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosis of CRCP as evident by symptoms and signs including pain on active abduction or external rotation and positive impingement test;
symptoms of pain in shoulder for > 3 months;
average movement pain > 3 on a 10 cm visual analogue scale;
aged ≥ 18 years;
able to understand written and spoken English.

Exclusion Criteria:

severe pain at rest, defined as > 7 on a visual analogue scale;
global restriction of shoulder movements;
systemic inflammatory joint disease;
x-ray evidence of shoulder osteoarthritis or fracture;
calcification about the shoulder joint;
reason to suspect a complete rotator cuff rupture (eg. weakness of arm elevation, a positive "drop arm sign", a high riding humerus visible on x-ray or a complete tear on ultrasound);
previous shoulder surgery on affected arm;
physiotherapy, corticosteroid injection or hydrodilatation for shoulder in past 3 months;
commenced non-steroidal antiinflammatory medication (NSAIDs) or conservative intervention in past 2 weeks.

Sites / Locations

University of Melbourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active physiotherapy

Placebo physiotherapy

Arm Description

Manual therapy and home exercise program

Outcomes

Primary Outcome Measures

Shoulder Pain and Disability Index

Participant perceived global rating of change post treatment

Secondary Outcome Measures

Shoulder Pain and Disability Index at followup

Participant perceived global rating of change at followup

Australian Quality of Life Index at followup

Isometric Shoulder strength using manual muscle tester post treatment and followup

Participant assessment of average pain and restriction of activity post treatment and followup

Cost effectiveness analysis

Full Information

NCT ID

NCT00415441

First Posted

December 21, 2006

Last Updated

January 15, 2013

Sponsor

University of Melbourne

Collaborators

National Health and Medical Research Council, Australia

1. Study Identification

Unique Protocol Identification Number

NCT00415441

Brief Title

Effectiveness of Physiotherapy for Chronic Shoulder Pain

Official Title

Efficacy and Cost-effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Melbourne

Collaborators

National Health and Medical Research Council, Australia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to investigate whether a physiotherapy program reduces pain and improves disability and quality-of-life in people with chronic shoulder pain. The main study hypotheses are that (i) A 10-week physiotherapy treatment will result in significantly greater reductions in pain and disability than placebo treatment in individuals with chronic shoulder pain (ii) Improvements in pain and disability following a 10-week physiotherapy treatment will be maintained at a 3-month follow-up.

Detailed Description

Chronic rotator cuff pathology (CRCP) is a common cause of musculoskeletal morbidity in the community. Physiotherapy is often the first line of management for this condition. However, the effectiveness of physiotherapy for CRCP has not been well studied. Thus this project primarily aims to investigate the effect of a multimodality physiotherapy program to treat CRCP where effect is measured in terms of pain, disability and health-related quality of life. The secondary aim is to evaluate the cost-effectiveness of physiotherapy as a treatment for CRCP. Comparison: physiotherapy program comprising stretches, exercises, manual techniques versus placebo physiotherapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain

Keywords

physiotherapy, exercise, manual therapy, shoulder pain, rotator cuff

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active physiotherapy

Arm Type

Experimental

Arm Description

Manual therapy and home exercise program

Arm Title

Placebo physiotherapy

Arm Type

Placebo Comparator

Arm Description

Manual therapy and home exercise program

Intervention Type

Procedure

Intervention Name(s)

Physiotherapy program

Intervention Type

Procedure

Intervention Name(s)

Placebo physiotherapy treatment

Primary Outcome Measure Information:

Title

Shoulder Pain and Disability Index

Time Frame

Baseline and 11 weeks

Title

Participant perceived global rating of change post treatment

Time Frame

11 weeks

Secondary Outcome Measure Information:

Title

Shoulder Pain and Disability Index at followup

Time Frame

22 weeks

Title

Participant perceived global rating of change at followup

Time Frame

22 weeks

Title

Australian Quality of Life Index at followup

Time Frame

Baseline, 11 weeks and 22 weeks

Title

Isometric Shoulder strength using manual muscle tester post treatment and followup

Time Frame

Baseline, 11 weeks and 22 weeks

Title

Participant assessment of average pain and restriction of activity post treatment and followup

Time Frame

Baseline, 11 weeks and 22 weeks

Title

Cost effectiveness analysis

Time Frame

Baseline, 11 weeks and 22 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosis of CRCP as evident by symptoms and signs including pain on active abduction or external rotation and positive impingement test; symptoms of pain in shoulder for > 3 months; average movement pain > 3 on a 10 cm visual analogue scale; aged ≥ 18 years; able to understand written and spoken English. Exclusion Criteria: severe pain at rest, defined as > 7 on a visual analogue scale; global restriction of shoulder movements; systemic inflammatory joint disease; x-ray evidence of shoulder osteoarthritis or fracture; calcification about the shoulder joint; reason to suspect a complete rotator cuff rupture (eg. weakness of arm elevation, a positive "drop arm sign", a high riding humerus visible on x-ray or a complete tear on ultrasound); previous shoulder surgery on affected arm; physiotherapy, corticosteroid injection or hydrodilatation for shoulder in past 3 months; commenced non-steroidal antiinflammatory medication (NSAIDs) or conservative intervention in past 2 weeks.

Overall Study Officials: