Effectiveness of Physiotherapy for Chronic Shoulder Pain

NCT00415441 | Completed Phase 3

• 1 other identifier: 299890
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Shoulder Pain and Disability Index

  Baseline and 11 weeks

• Participant perceived global rating of change post treatment

  11 weeks

Secondary Outcomes (6)

• Shoulder Pain and Disability Index at followup

  22 weeks

• Participant perceived global rating of change at followup

  22 weeks

• Australian Quality of Life Index at followup

  Baseline, 11 weeks and 22 weeks

• Isometric Shoulder strength using manual muscle tester post treatment and followup

  Baseline, 11 weeks and 22 weeks

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

  Baseline, 11 weeks and 22 weeks

Study Arms (2)

Active physiotherapy

EXPERIMENTAL

Manual therapy and home exercise program

Procedure: Physiotherapy program

Placebo physiotherapy

PLACEBO COMPARATOR

Manual therapy and home exercise program

Procedure: Placebo physiotherapy treatment

Interventions

Physiotherapy program PROCEDURE

Active physiotherapy

Placebo physiotherapy treatment PROCEDURE

Placebo physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Melbourne: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Related Publications (2)

• Bennell K, Wee E, Coburn S, Green S, Harris A, Staples M, Forbes A, Buchbinder R. Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial. BMJ. 2010 Jun 8;340:c2756. doi: 10.1136/bmj.c2756.

  PMID: 20530557 DERIVED

• Bennell K, Coburn S, Wee E, Green S, Harris A, Forbes A, Buchbinder R. Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: a protocol for a randomised, double-blind, placebo-controlled trial. BMC Musculoskelet Disord. 2007 Aug 31;8:86. doi: 10.1186/1471-2474-8-86.

  PMID: 17761004 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Motor Activity

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Kim L Bennell, PhD

  University of Melbourne, Australia

  PRINCIPAL INVESTIGATOR

• Rachelle Buchbinder, MPH

  Monash University, Australia

  PRINCIPAL INVESTIGATOR

• Sally Green, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

• Anthony Harris

  Monash University

  PRINCIPAL INVESTIGATOR

• Andrew Forbes

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: March 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

AU (1)