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
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
-
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.
-
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.