Condition category
Musculoskeletal Diseases
Date applied
23/12/2009
Date assigned
11/02/2010
Last edited
26/08/2014
Prospective/Retrospective
Prospectively 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

Prof Martin Underwood

ORCID ID

Contact details

Warwick Clinical Trials Unit
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-0808-17039

Study information

Scientific title

Improving Patient Choice in Treating Low Back Pain: a cluster randomised controlled trial

Acronym

IMPACT-LBP

Study hypothesis

A decision support package designed for use in physiotherapy departments to help patients seeking care for their back pain will ensure better, more informed choices about their treatment and should improve patient satisfaction.

As of 09/09/2010 this record was updated to include extended trial dates; the initial dates at the time of registration were as follows:
Initial anticipated start date: 01/04/2010
Initial anticipated end date: 31/03/2012

Please note that as of 21/02/2013, the following changes were made to the trial record:
1. The scientific title was previously "Improving Patient Choice in Treating Low Back Pain: a single centre randomised controlled trial"
2. The target number of participants was updated from 150 to 158
3. The anticipated end date was updated from 31/05/2012 to 31/12/2012

Ethics approval

Warwickshire Research Ethics Committee (REC), 5th February 2010

Study design

Cluster 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

Back pain

Intervention

Curent interventions as of 21/02/2013:
Physiotherapists will be randomised to intervention or control. Those in the intervention arm will be trained on informed shared decision making which they will use during the consultation process. Physiotherapist NOT trained on informed shared decision making will continue to provide standard care that would normally be received if you were not in the trial.

Previous interventions until 21/02/2013:
Participants will be randomly allocated to one of the following two groups:
1. Physiotherapist trained on informed shared decision making: The physiotherapist will have been trained on informed shared decision making and they will use this during the consultation process.
2. Physiotherapist NOT trained on informed shared decision making: This will be standard care that would normally be received if you were not in the trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Satisfaction with treatment at three months using a five-point Likert Scale (very satisfied to very dissatisfied)

Secondary outcome measures

Measured at baseline and 3 months:
1. Roland Morris Disability Questionnaire (RMDQ) - the leading measure of LBP-related disability in primary care trials
2. Modified Von Korff - a measure of LBP and disability over the preceding month
3. 12-item short form health survey (SF-12) - a generic measure of health-related quality of life
4. EuroQol - a generic measure of health utility that is designed for use in RCTs
5. Hospital Anxiety and Depression Scale (HADS) - an established and validated self rating instrument for anxiety and depression
6. Pain Self-Efficacy Questionnaire (PSEQ) - an established measure self-efficacy for people with chronic pain
7. Fear Avoidance Beliefs Questionnaire (FABQ) - the physical sub-scale of FABQ measures attitude to movement in back pain
8. A question on change in ability to perform daily tasks
9. A question on change in low back pain since beginning treatment
10. Compliance - we will measure compliance from the physiotherapy department’s attendance records. We will also collect data from participants on health service use and health transition
11. Immediate follow-up assessment will focus on satisfaction with the decision making process. We will use the 'Satisfaction with Decision Scale' to measure satisfaction with the health care decision.

Overall trial start date

01/06/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients seeking treatment for non specific low back pain
2. Aged greater than or equal to 18 years, either sex
3. Fluent spoken and written English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

158

Participant exclusion criteria

1. Severe psychiatric or personality disorders
2. Terminal illness
3. Critical illness
4. Possible serious spinal pathology including tumour, sepsis or fracture

Recruitment start date

01/06/2010

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warwick Clinical Trials Unit
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

c/o Peter Hedges
University House
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

http://www2.warwick.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-17039)

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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21352528
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25146587

Publication citations

  1. Protocol

    Patel S, Brown S, Friede T, Griffiths F, Lord J, Ngunjiri A, Thistlethwaite J, Tysall C, Woolvine M, Underwood M, Study protocol: improving patient choice in treating low back pain (IMPACT-LBP): a randomised controlled trial of a decision support package for use in physical therapy., BMC Musculoskelet Disord, 2011, 12, 52, doi: 10.1186/1471-2474-12-52.

  2. Results

    Patel S, Ngunjiri A, Hee SW, Yang Y, Brown S, Friede T, Griffiths F, Lord J, Sandhu H, Thistlethwaite J, Tysall C, Underwood M, Primum non nocere: shared informed decision making in low back pain - a pilot cluster randomised trial., BMC Musculoskelet Disord, 2014, 15, 1, 282, doi: 10.1186/1471-2474-15-282.

Additional files

Editorial Notes