Condition category
Musculoskeletal Diseases
Date applied
18/10/2004
Date assigned
13/12/2004
Last edited
16/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nadine Foster

ORCID ID

Contact details

School of Health & Rehabilitation
MacKay Building
Keele University
Staffordshire
ST5 5BG
United Kingdom
+44 (0)1782 584195
n.foster@keele.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

COMPLEMENT trial

Study hypothesis

The primary aim of the study is to investigate the short-term effectiveness (six months following intervention) of a previously developed, directly-posted information package, that details contextualised evidence-based recommendations for the management of acute back pain, on the reported behaviour, attitudes and beliefs of a combined sample of chiropractors, osteopaths and musculoskeletal physiotherapists in the UK.

Our secondary objectives aims are:
1. To describe patterns of reported behaviour, attitudes and beliefs, within and between professional groups at baseline
2. To identify baseline factors that are associated with a change in reported behaviour of these practitioners (such as demographic data, attitudes and beliefs of practitioners)
3. To make recommendations for future research on implementation strategies in these professional groups

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Low back pain - Practitioner reported behaviour and beliefs

Intervention

Intervention: Previously developed, directly-posted information package that details contextualised evidence-based recommendations for the management of acute back pain.

Control: No intervention.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Health Care Providers Pain and Impairment Relationship scale (HC-PAIRS), first published by Rainville et al 1995.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2003

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

UK Chiropractors, Osteopaths and Musculoskeletal Physiotherapists:
1. Chiropractors: Registered with the General Chiropractic Council and British Chiropractic Association
2. Osteopaths: Registered with the General Osteopathic Council
3. Physiotherapists: Registered with the Chartered Society of Physiotherapy and self-selected as 'musculoskeletal' by speciality

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

1700

Participant exclusion criteria

1. Non-UK practitioners
2. Practitioners living or working in Scotland (due to ongoing national educational campaign www.workingbacksscotland.com)
3. Practitioners who reported that they had retired
4. Practitioners who reported that they were non-practicing
5. Practitioners who reported that they were not currently involved directly in the management of LBP patients
6. Practitioners working at same address as a practitioner already recruited to the trial

Recruitment start date

01/11/2003

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Health & Rehabilitation
Staffordshire
ST5 5BG
United Kingdom

Sponsor information

Organisation

Keele University (UK)

Sponsor details

c/o Prof Julius Sim
School of Health & Rehabilitation
Staffordshire
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

http://www.keele.ac.uk/

Funders

Funder type

Research organisation

Funder name

School of Health & Rehabilitation, Keele University (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Osteopathic Educational Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

General Osteopathic Council (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Anglo-European College of Chiropractic (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

British Chiropractic Association (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16033646
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20308941

Publication citations

  1. Protocol

    Evans DW, Foster NE, Underwood M, Vogel S, Breen AC, Pincus T, Testing the effectiveness of an innovative information package on practitioner reported behaviour and beliefs: the UK Chiropractors, Osteopaths and Musculoskeletal Physiotherapists Low back pain ManagemENT (COMPLeMENT) trial [ISRCTN77245761]., BMC Musculoskelet Disord, 2005, 6, 41, doi: 10.1186/1471-2474-6-41.

  2. Results

    Evans DW, Breen AC, Pincus T, Sim J, Underwood M, Vogel S, Foster NE, The effectiveness of a posted information package on the beliefs and behavior of musculoskeletal practitioners: the UK Chiropractors, Osteopaths, and Musculoskeletal Physiotherapists Low Back Pain ManagemENT (COMPLeMENT) randomized trial., Spine, 2010, 35, 8, 858-866, doi: 10.1097/BRS.0b013e3181d4e04b.

Additional files

Editorial Notes