Access trial: Clinical and cost outcomes of public versus private physiotherapy for low back pain

ISRCTN	ISRCTN96155881
DOI	https://doi.org/10.1186/ISRCTN96155881
Protocol serial number	2003/1
Sponsor	Health Research Board (HRB) (Ireland)
Funder	Health Research Board (HRB) (Ireland) (Project Grant: 2003/1)

Submission date: 05/08/2009
Registration date: 25/09/2009
Last edited: 25/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Deirdre Hurley
Scientific

UCD School of Physiotherapy and Performance Science
Health Sciences Centre
Belfield
Dublin
4
Ireland

Email	deirdre.hurleyosing@ucd.ie

Study information

Primary study design	Interventional
Study design	Pragmatic randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised clinical trial of public hospital-based versus private clinic-based physiotherapy for low back pain - clinical and cost outcomes
Study acronym	Access Trial
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Roland Morris Disability Questionnaire, measured at 3, 6 and 12 months post-randomisation.
Key secondary outcome measure(s)	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
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	160
Key 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
Key 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 patients ability to complete questionnaires
Date of first enrolment	01/02/2005
Date of final enrolment	30/06/2007

Locations

Countries of recruitment

Ireland

Study participating centre

UCD School of Physiotherapy and Performance Science

Dublin
4
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/01/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes