QUeen Elizabeth physiotherapy post lumbar discectomy STudy: a pilot and feasibility trial - QUEST
| ISRCTN | ISRCTN33808269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33808269 |
| Secondary identifying numbers | 1 |
- Submission date
- 09/11/2012
- Registration date
- 18/12/2012
- Last edited
- 13/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
At some time in their life, 60% to 80% of people will have low back problems and surgery for its treatment is the greatest cost to the NHS. Lumbar discectomy surgery is a common procedure for patients with pain in their legs. However, 30-70% of patients continuing to have problems even after the surgery. Recovery after surgery is, therefore, an important area to research. Currently, treatment following lumbar discectomy comprises a patient leaflet or physiotherapy or both. Practice varies across hospitals and it is unknown whether providing a patient leaflet and physiotherapy benefits patients' recovery compared with use of a patient leaflet alone. This is why we are conducting the study. This study is conducted to help us improve the design and prospects to do a future larger study.
Who can participate?
Men and women aged over 18 who have recently undergone the first lumbar discectomy surgery
What does the study involve?
All participants are asked to attend two assessment clinics at 4 and 16 weeks after surgery and half the participants at each hospital are asked to attend a third assessment clinic at 30 weeks after surgery. Assessments comprise of a short questionnaire and two simple physical tests that assess how well patients can move their back and legs. Patients are randomly allocated one of the following groups: patient leaflet and individual outpatient physiotherapy, or patient leaflet alone; and 30-week follow-up, or not. Participants allocated to receive individual outpatient physiotherapy and the patient leaflet receive up to 8 treatment sessions with a physiotherapist, starting as soon as possible after the 4-week assessment clinic. At their final assessment visit, participants are invited to attend a meeting with other participants who received the same treatment, to discuss their experience.
What are the possible benefits and risks of participating?
We cannot promise that taking part in the study will help the participants, but the information obtained could help them and patients like them in the future. All participants receive a copy of a Patient Leaflet that has been designed specifically for patients following lumbar discectomy surgery. The leaflet contains information about the patient's back, surgery and recovery after surgery. There are no known risks of taking part in the study.
Where is the study run from?
Queen Elizabeth Hospital Birmingham (UK) and Salford Royal NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
Recruitment for the study started in January 2013. Participants will be enrolled on the study for 7 months.
Who is funding the study?
Queen Elizabeth Hospital Birmingham Charity (UK)
Who is the main contact?
Dr Alison Rushton
a.b.rushton@bham.ac.uk
Contact information
Scientific
University of Birmingham
School of Health & Population Sciences
College of Medical and Dental Sciences
52 Pritchatts Road
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 415 8597 |
|---|---|
| a.b.rushton@bham.ac.uk |
Study information
| Study design | Pilot/feasibility study of a randomised controlled trial with two arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | QUeen Elizabeth Physiotherapy post lumbar discectomy STudy: a feasibility and pilot phase II trial to inform the development of a future phase III randomised controlled trial (QUEST) |
| Study acronym | QUEST |
| Study objectives | One to one physiotherapy plus the Patient Leaflet will be more beneficial than the Patient Leaflet (phase II trial) |
| Ethics approval(s) | West Midlands - Solihull Research Ethics Committee, 25/09/2012, ref: 12/WM/0224 |
| Health condition(s) or problem(s) studied | Rehabilitation following lumbar spinal surgery |
| Intervention | 1. Up to 8 sessions of individualised 1-1 physiotherapy over an 8-week period; treatment in-line with pre-defined framework for decision-making; starting approximately 4 weeks post surgery AND specifically designed patient leaflet 2. Specifically designed patient leaflet |
| Intervention type | Behavioural |
| Primary outcome measure | Roland Morris Disability Questionnaire (0 to 24) |
| Secondary outcome measures | 1. Global Perceived Effect scale (0 to 7) 2. VAS back pain (0 to 10cm) & VAS leg pain (0 to 10cm) 3. Straight Leg Raise (cm) 4. Time to return to work / normal function / full duty (as relevant) from date of operation 5. EQ-5D 5L 6. Tampa Scale for Kinesiophobia (fear of movement) 7. Fear avoidance and beliefs questionnaire 8. Range of lumbar movement 9. Use of medication 10. Re-operation 11. Level of compliance with exercises |
| Overall study start date | 26/10/2012 |
| Completion date | 26/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 |
| Key inclusion criteria | 1. Male and female patients aged >18 years 2. Post primary, single level, lumbar discectomy (including microdiscectomy) 3. Ability to communicate in English |
| Key exclusion criteria | 1. Previous surgery at the same spinal level 2. Co-morbidities that might impact on ability to participate in study interventions e.g. neurological disorders, cognitive dysfunction, uncontrolled cardiovascular disease, osteoporotic fracture, spondylolythesis, MS, tumour 3. Complications from surgery e.g. excessive bleeding, severe intra-operative root damage, level error, or severe wound infection that would prevent participation in either intervention 4. Participation in a concurrent trial |
| Date of first enrolment | 13/01/2013 |
| Date of final enrolment | 26/05/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
B15 2TT
United Kingdom
Sponsor information
University/education
Research Governance Team
Aston Webb Building
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 4418 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/researchsupportgroup |
"ROR" |
https://ror.org/03angcq70 |
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? |
|---|---|---|---|---|---|
| Results article | results | 12/11/2015 | Yes | No | |
| Results article | results | 09/11/2016 | Yes | No |
Editorial Notes
13/02/2017: Publication reference added.
