Condition category
Musculoskeletal Diseases
Date applied
05/08/2009
Date assigned
25/09/2009
Last edited
25/09/2012
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 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 measures

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

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

http://www.hrb.ie

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21289590

Publication citations

  1. 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.

Additional files

Editorial Notes