Access trial: Clinical and cost outcomes of public versus private physiotherapy for low back pain
| ISRCTN | ISRCTN96155881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96155881 |
| Secondary identifying numbers | 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
Scientific
UCD School of Physiotherapy and Performance Science
Health Sciences Centre
Belfield
Dublin
4
Ireland
| deirdre.hurleyosing@ucd.ie |
Study information
| Study design | Pragmatic randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/02/2005 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 patientsÂ’ 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
4
Ireland
Sponsor information
Health Research Board (HRB) (Ireland)
Government
Government
73 Lower Baggot St
Dublin
2
Ireland
| hrb@hrb.ie | |
| Website | http://www.hrb.ie |
"ROR" |
https://ror.org/003hb2249 |
Funders
Funder type
Government
Health Research Board (HRB) (Ireland) (Project Grant: 2003/1)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- HRB
- Location
- Ireland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
