Shoulder PainPhase 3NCT00415441

Effectiveness of Physiotherapy for Chronic Shoulder Pain

A Phase 3 study testing Physiotherapy program in people with Shoulder Pain, run by University of Melbourne at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Shoulder Pain
What is being tested?: Physiotherapy program
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteAustralia
Study dates: Mar 2004to Sep 2008
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

University of Melbourne
Melbourne, Victoria, 3010

Other trials in Australia

About this study

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

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.

Read the 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

Conditions: Shoulder Pain
Being tested: Physiotherapy program, Placebo physiotherapy treatment
Keywords: physiotherapy, exercise, manual therapy, shoulder pain, rotator cuff
Medical subject headings: Shoulder Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physiotherapy programProcedure or surgery
Placebo physiotherapy treatmentProcedure or surgery

Study groups in NCT00415441
Study group	Role	What they receive
Active physiotherapy	Experimental	Manual therapy and home exercise program Receives: Procedure: Physiotherapy program
Placebo physiotherapy	Placebo comparator	Manual therapy and home exercise program Receives: Procedure: Placebo physiotherapy treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Shoulder Pain and Disability Index
Measured: Baseline and 11 weeks
Participant perceived global rating of change post treatment
Measured: 11 weeks

Secondary outcomes (6)

Shoulder Pain and Disability Index at followup
Measured: 22 weeks
Participant perceived global rating of change at followup
Measured: 22 weeks
Australian Quality of Life Index at followup
Measured: Baseline, 11 weeks and 22 weeks
Isometric Shoulder strength using manual muscle tester post treatment and followup
Measured: Baseline, 11 weeks and 22 weeks
Participant assessment of average pain and restriction of activity post treatment and followup
Measured: Baseline, 11 weeks and 22 weeks
Cost effectiveness analysis
Measured: Baseline, 11 weeks and 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Sep 2008

First posted22 Dec 2006 (estimated)
Study startMar 2004
Primary completionJun 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Shoulder PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00415441
Sponsor's protocol ID: 299890
Status last verified: Jan 2013
First submitted: 21 Dec 2006
Last updated: 17 Jan 2013
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 20530557
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.
PubMed 17761004

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain

All Shoulder Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Cost-effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology
ClinicalTrials.gov ID: NCT00415441
Acronym / sponsor ID: 299890
Conditions: Shoulder Pain
Keywords: physiotherapy, exercise, manual therapy, shoulder pain, rotator cuff
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University of MelbourneUniversity, hospital or other
Collaborators: National Health and Medical Research Council, Australia
Study start: Mar 2004
Primary completion: Jun 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 22 Dec 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Comparison: physiotherapy program comprising stretches, exercises, manual techniques versus placebo physiotherapy

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active physiotherapy	Experimental	Procedure: Physiotherapy programManual therapy and home exercise program
Placebo physiotherapy	Placebo comparator	Procedure: Placebo physiotherapy treatmentManual therapy and home exercise program

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physiotherapy program	Procedure or surgery	Active physiotherapy
Placebo physiotherapy treatment	Procedure or surgery	Placebo physiotherapy

Primary outcome

Shoulder Pain and Disability Index
Time frame: Baseline and 11 weeks
Participant perceived global rating of change post treatment
Time frame: 11 weeks

6 secondary outcomes

Shoulder Pain and Disability Index at followup
Time frame: 22 weeks
Participant perceived global rating of change at followup
Time frame: 22 weeks
Australian Quality of Life Index at followup
Time frame: Baseline, 11 weeks and 22 weeks
Isometric Shoulder strength using manual muscle tester post treatment and followup
Time frame: Baseline, 11 weeks and 22 weeks
Participant assessment of average pain and restriction of activity post treatment and followup
Time frame: Baseline, 11 weeks and 22 weeks
Cost effectiveness analysis
Time frame: Baseline, 11 weeks and 22 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
Derived from this study: PubMed 20530557Bennell 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.
Derived from this study: PubMed 17761004Bennell 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.

Related trials for Shoulder Pain

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kim L Bennell, PhD principal investigator

University of Melbourne, Australia

Rachelle Buchbinder, MPH principal investigator

Monash University, Australia

Sally Green, PhD principal investigator

Monash University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Physiotherapy program in people with Shoulder Pain, run by University of Melbourne at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder Pain and Disability Index (time frame: Baseline and 11 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00415441, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.