Exploring interaction in back pain consultations
| ISRCTN | ISRCTN01354132 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01354132 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/04/2013
- Registration date
- 07/05/2013
- Last edited
- 09/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This is an initial study looking at the communication and decision-making that takes place in consultations between physiotherapists and people with back pain. Our goal is to provide some workshops for clinicians to help improve their communication skills and see whether this improves the outcome of treatment and experience of the service from the patientsÂ’ point of view.
Who can participate?
Physiotherapists working in Southern Health NHS Foundation Trust; and people with back pain (aged 18 years or over, able to communicate in English without assistance, with no signs or symptoms suggesting possible serious spinal pathology and no recent spinal surgery).
What does this study involve?
In this initial study, 60 people with back pain will be asked to complete a questionnaire booklet after they have attended their initial consultation. Twelve of these patients will also be asked their permission for a research assistant to watch and audio-record their consultation.
The twelve physiotherapists will be randomly be allocated to one of two groups. One group will attend a workshop about communication skills (the content of which has been developed from earlier work) and the other group will have a workshop about manual therapy skills. The physiotherapists will be asked to evaluate the workshops (via an interview) and two months later, discuss whether the workshops have changed their clinical practice (via focus groups). Both workshops will be delivered by the same facilitator and will be supported by a training manual.
After the workshops, a further 60 people with back pain will be asked to complete the questionnaire booklet as before and once again, twelve of these will be asked if their consultation can be watched and audio-recorded by the research assistant.
What are the possible benefits and risks of participating?
There will be no direct benefit to those taking part before the workshops. The physiotherapists will receive additional teaching and any benefit to people with back pain (after the physiotherapists have attended the workshops) will be measured. Information obtained from this initial study will be used to devise a larger study involving other centres.
By taking part in this study, there are no anticipated risks of physical injury or harm.
Where is the study run from?
This study has been set up by the University of Southampton in collaboration with Southern Health NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
April 2013 to 31st July 2013
Who is funding the study?
Arthritis Research UK (UK)
Who is the main contact?
Dr Lisa Roberts
L.C.Roberts@soton.ac.uk
Contact information
Scientific
Building 45
Faculty of Health Sciences
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
| Phone | +44(0) 23 8059 5311 |
|---|---|
| L.C.Roberts@soton.ac.uk |
Study information
| Study design | Randomised controlled feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Feasibility randomised controlled trial: Exploring interaction in back pain consultations |
| Study objectives | This feasibility study is testing the efficacy of a theory-based intervention (a communication skills training package for physiotherapists), supported by a training manual. The key research questions are: 1. Can an educational intervention (a communication skills training package for physiotherapists) increase patients' perceived involvement in decision-making processes and improve: perceptions of empathy; enablement; communication; experience; functional outcome; and cost-effectiveness? 2. Can the educational intervention increase clinician beliefs and behaviours that they are likely to increase patient involvement in decision-making processes? |
| Ethics approval(s) | Liverpool Central REC, 20/02/2013 Ref: 13/NW/0164 |
| Health condition(s) or problem(s) studied | Back pain |
| Intervention | Educational workshops (communication skills and manual therapy clinical skills). Communication skills: 1-day workshop, supported by a training manual, focussing on 3 aspects of communication. Manual therapy skills: 1-day workshop, supported by a training manual, focussing on specific aspects of delivering manual therapy treatments for people with back pain. |
| Intervention type | Other |
| Primary outcome measure | The Consultation And Relational Empathy (CARE) measure. Primary and secondary measures are recorded at baseline (pre-workshops) and post-workshops (until a quota of 5 new patients have been assessed per participating physiotherapist). The semi-structured interviews to evaluate the workshops will take place within one week of the workshop and the focus group to discuss any impact on practice will be at 2 months. |
| Secondary outcome measures | 1. Intensity of pain (numerical rating scale) 2. The Patient Enablement Instrument (PEI) 3. Brief Illness Perceptions Questionnaire 4. Patient Feedback questionnaire (Chartered Society of Physiotherapy) 5. 7-point enablement scales 6. Roland-Morris Disability Questionnaire 7. EQ5D-5L 8. Satisfaction with the consultation scale |
| Overall study start date | 22/04/2013 |
| Completion date | 31/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 physiotherapists & 120 patients. |
| Key inclusion criteria | Physiotherapists: 1. Registered with the Health and Care Professions Council 2. Band 6 grade working within the musculoskeletal outpatient service at Southern Health NHS Foundation Trust 3. Treating patients with back pain. Patients: 1. Aged 18 or over, either sex 2. Referred to the outpatient physiotherapy service 3. Reporting back pain 4. With or without referred leg pain 5. Not having received any physical therapy (NHS or private) in the previous three months |
| Key exclusion criteria | Physiotherapists: 1. Not fulfilling the inclusion criteria or 2. If they have been involved in either of the first two studies in this research programme, from which the content of the educational workshop was derived. Patients: 1. If they present with 'red flags' (signs / symptoms suggesting possible serious spinal pathology) 2. If they have received spinal surgery during this care episode 3. If they have another musculoskeletal disorder that is more troublesome than their back pain 4. If they have a serious psychiatric or psychological condition identified by the referring doctor; or 5. If they are unable to communicate in English without assistance |
| Date of first enrolment | 22/04/2013 |
| Date of final enrolment | 31/07/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SO17 1BJ
United Kingdom
Sponsor information
University/education
C/O Dr Martina Prude
Research Governance Office
Legal Services B37, 4009
Highfield
Southampton
SO17 1BJ
England
United Kingdom
| Website | http://www.southampton.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Charity
No information available
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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/06/2016: No publications found, verifying study status with principal investigator.
