Condition category
Musculoskeletal Diseases
Date applied
08/11/2013
Date assigned
08/11/2013
Last edited
18/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Low back pain is one of the most common and costly problems seen by general practitioners (GP). The aim of this study is to develop and test an interactive internet intervention specifically designed for patients having low back pain consulting their GP. Financial pressures on the NHS restrict access to face-to-face physiotherapy. An internet intervention may provide a unique and efficient means for offering education and advice for the self-management of low back pain. Patient feedback is used to inform amendments to the structure and content (phase 1). The acceptability of the intervention and the feasibility of this study are then assessed (phase 2).

Who can participate?
Adult patients experiencing low back pain and who have access to the internet

What does the study involve?
Participants are randomly allocated to one of three groups. The first group receives the internet intervention with telephone physiotherapist support, the second group receives the internet intervention without support, and the third group receives usual care from their GP. All patients are followed up after 3 months. Factors including recruitment rates, the extent of patient interaction with the intervention and patient dropout are assessed. Interviews are conducted with GPs, patients completing the intervention, and physiotherapists giving the telephone support.

What are the possible benefits and risks of participating?
Using the internet allows patients immediate access to tailored information in their own homes. The multidisciplinary team of general practitioners and specialists works collaboratively with patients to develop and amend existing high quality educational materials, making them suitable for delivery in an interactive internet format. There are no risks associated with participation in the study.

Where is the study run from?
The study is run from various GP surgeries around Hampshire and Wiltshire ares of the UK.

When is the study starting and how long is it expected to run for?
January 2015 to December 2015

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Adam Geraghty
a.w.geraghty@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adam Geraghty

ORCID ID

http://orcid.org/0000-0001-7984-8351

Contact details

Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14614

Study information

Scientific title

Internet intervention supporting management of low back pain in primary care: a feasibility study

Acronym

SupportBack

Study hypothesis

This study will examine the feasibility of the trial design and acceptability of the internet intervention for management of low back pain in primary care.

Ethics approval

NRES Committee South Central - Southampton A, 25/06/2013, ref: 13/SC/0202

Study design

Randomised; Interventional; Design type: Not specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

Patients will consent to the study online prior to completing the baseline information and questionnaires. They will then be randomised to three groups automatically, using internet-based software:
1. Internet intervention with telephone physiotherapist support: SupportBack is an online intervention providing advice and support in getting active for people with low back pain. Provides tailored activity programme and self management advice
2. Internet intervention with no telephone physiotherapist support
3. Usual care from the GP
Follow up will take place at 3 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Recruitment rate; Timepoint(s): Baseline & 3 months

Secondary outcome measures

1. Back pain care related resource use (i.e. no of GP visits) collected by simple questions; Timepoint(s): 3 months
2. Quality of life, measured with EuroQol EQ-5D; Timepoint(s): Baseline & 3 months
3. Objective measures of use of internet intervention; Timepoint(s): Baseline & 3 months
4. Patient experience & perceived usefulness of intervention, measured by qualitative interview/quantitative scale; Timepoint(s): Baseline & 3 months
5. Patient experience/perceived usefulness of phone support, measured by qualitative interview/quantitative scale; Timepoint(s): 3 months
6. Problematic Experiences of Therapy Scale (PETS); Timepoint(s): 3 months
7. Roland Morris Disability Questionnaire (RMDQ); Timepoint(s): Baseline & 3 months
8. Time off work via simple questions; Timepoint(s): Baseline & 3 months
9. Visual Analogue Scale for measuring pain as a process measure across the study; Timepoint(s): Baseline & 3 months

Overall trial start date

13/01/2014

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Access to the internet and an active email address
2. Current low back pain
3. Prior presentation in primary care with low back pain (for those invited directly from practice lists)
4. An ability to read/understand English without assistance
Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 70; UK Sample Size: 70

Participant exclusion criteria

1. Patients under 18
2. Clinical indicators of potentially serious spinal disease (indicated through a 'red flag' screen. Red flags are rare in primary care, thus we expect the majority of patients with low back pain to be eligible for this trail)
3. Those patients without the internet will be ineligible for this trial and will be offered usual care

Recruitment start date

01/01/2015

Recruitment end date

01/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Southampton Primary Care Academic Unit
School of Medicine
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed journal

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Adam Geraghty (a.w.geraghty@soton.ac.uk)

Intention to publish date

01/04/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/12/2014: the recruitment dates were added to the trial record and the overall trial end date was changed from 13/03/2014 to 01/12/2015.