Contact information
Type
Scientific
Primary contact
Dr Deirdre Hurley
ORCID ID
Contact details
UCD School of Physiotherapy and Performance Science
Health Sciences Centre
Belfield
Dublin
4
Ireland
deirdre.hurleyosing@ucd.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2003/1
Study information
Scientific title
A randomised clinical trial of public hospital-based versus private clinic-based physiotherapy for low back pain - clinical and cost outcomes
Acronym
Access Trial
Study hypothesis
There was a difference in clinical outcomes and costs between public hospital-based and private clinic-based physiotherapy treatment of patients with low back pain.
Ethics approval
Mater Misericordiae Hospital, Connolly Hospital and Sligo General Hospital Research Ethics Committees and the Irish College of General Practitioners Research Ethics Committee approved the study in 2005.
Study design
Pragmatic randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Low back pain
Intervention
As this was a pragmatic trial the physiotherapists were permitted to use whatever form of treatment considered appropriate following individualised assessment; i.e. advice/education, manual therapy, exercise therapy, electrotherapy, cognitive behavioural therapy, multidisciplinary team management.
Total duration of treatment:
There was no limit on the total duration of treatment. Previous work by the research team had established the mean (SD) number of treatments for LBP in hospital settings as five visits over 6 weeks, and in the private setting as two visits over 1 week.
Total duration of follow-up:
12 months (three timepoints - 3, 6 and 12 months).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Roland Morris Disability Questionnaire, measured at 3, 6 and 12 months post-randomisation.
Secondary outcome measures
All measured at 3, 6 and 12 months post-randomisation:
1. 36-item Short Form health survey (version 2)
2. Fear Avoidance Beliefs Questionnaire
3. Back Beliefs Questionnaire
4. Euroqol Questionnaire
5. Patient Satisfaction with Outpatient Satisfaction Survey
6. Global Perceived Improvement Scale
Overall trial start date
01/02/2005
Overall trial end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female
2. Aged 18 to 65 years
3. Low back pain defined as pain radiation into the buttock and/or one or both lower limbs for at least 3 weeks
4. Referral by a general practitioner for physiotherapy treatment of low back pain
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
1. Reflex and/or motor signs of nerve root, spinal cord or cauda equina compression as urgent surgical opinion is required for these patients
2. Recent spinal fracture as clinical outcomes are likely to be different and some treatment approaches may be contraindicated due to recent fracture, e.g. spinal manipulation
3. Physiotherapy for LBP in the previous 12 months as clinical outcomes are likely to be different with possible carry over effect of previous treatment
4. Medicolegal proceedings as clinical outcomes are likely to be different
5. History of psychological/psychiatric illness due to potential negative influence on patient outcomes
6. Lack of fluency in English which may limit patientsÂ’ ability to complete questionnaires
Recruitment start date
01/02/2005
Recruitment end date
30/06/2007
Locations
Countries of recruitment
Ireland
Trial participating centre
UCD School of Physiotherapy and Performance Science
Dublin
4
Ireland
Sponsor information
Organisation
Health Research Board (HRB) (Ireland)
Sponsor details
73 Lower Baggot St
Dublin
2
Ireland
hrb@hrb.ie
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Board (HRB) (Ireland) (Project Grant: 2003/1)
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Ireland
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21289590
Publication citations
-
Results
Casserley-Feeney SN, Daly L, Hurley DA, The access randomized clinical trial of public versus private physiotherapy for low back pain., Spine, 2012, 37, 2, 85-96, doi: 10.1097/BRS.0b013e3182127457.