Internet intervention supporting management of low back pain in primary care
| ISRCTN | ISRCTN31034004 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31034004 |
| Secondary identifying numbers | 14614 |
- Submission date
- 08/11/2013
- Registration date
- 08/11/2013
- Last edited
- 17/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Scientific
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
 ORCID ID |
0000-0001-7984-8351 |
|---|
Study information
| Study design | Randomised; Interventional; Design type: Not specified |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Internet intervention supporting management of low back pain in primary care: a feasibility study |
| 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(s) | NRES Committee South Central - Southampton A, 25/06/2013, ref: 13/SC/0202 |
| 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 |
| Primary outcome measure | 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 study start date | 13/01/2014 |
| Overall study end date | 01/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 70; UK Sample Size: 70 |
| Total final enrolment | 87 |
| 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 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
- England
- United Kingdom
Study participating centre
SO16 5ST
United Kingdom
Sponsor information
University/education
Southampton Primary Care Academic Unit
School of Medicine
Aldermoor Close
Southampton
SO16 5ST
England
United Kingdom
"ROR" |
https://ror.org/01ryk1543 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/03/2018 | Yes | No | |
| Results article | qualitative results | 01/09/2020 | 17/12/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
17/12/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the 2018 reference.
13/03/2018: Publication reference added.
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.
