Better outcomes for older people with spinal trouble
| ISRCTN | ISRCTN12698674 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12698674 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/11/2015
- Registration date
- 03/05/2016
- Last edited
- 24/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Low back pain (LBP) is the leading cause of disability worldwide. Over 70% of people will suffer with LBP in their lifetime, and the chance of having the most serious forms of LBP increases with age. It is associated with loss of mobility and falls in older people leading to loss of independence and frailty, however, this is the time in life when GPs and patients are least likely to prioritise treatment for LBP. In later life people are much more likely to have other health conditions which they think are more important than LBP. Some older people just grin and bear the pain, accepting it as part of ageing. Although there is a large body of research in LBP, this has focused almost exclusively on younger people. Hence there is little guidance appropriate to older people. Lumbar spinal stenosis is a common back condition in older adults where the spinal cord is compressed due to narrowing of the spinal canal. This leads to a range of symptoms including pain, tingling, numbness or heaviness spreading from the back into one or both legs, together known as neurogenic claudication. Neurogenic claudication is a common symptom of lumbar spinal stenosis (narrowing of the spine leading to compression of the spinal cord), a leading cause of LBP in the aging population. Neurogenic claudication affects a person’s ability to walk and stand which impacts on their ability to remain independent. There is little research to help us know what type of physiotherapy is best for people with neurogenic claudication. The aim of this study is to compare the effectiveness of two different approaches to physiotherapy which have been designed to help older adults with neurogenic claudication to stay mobile and remain independent.
Who can participate?
Adults aged 65 years or over who live at home and report symptoms of neurogenic claudication.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in a 12-week group physiotherapy programme. This involves weekly hour-and-a-half long sessions of exercises and group discussions about ways to manage symptoms and be more physically active. Those in the second group receive an individual session with a physiotherapist in which they are provided with information about exercises and how best to manage their symptoms. These participants can receive two follow up sessions if required. Participants in both groups complete a number of questionnaires and physical assessments at the start of the study and again 6, 12 and 24 months later in order to find out if their symptoms have improved.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their back and leg symptoms because of the advice, information and exercises given to them by the physiotherapist. There is a risk of muscle soreness after completing some of the exercises however this is normal and the physiotherapist will provide advice on how to manage this. Some participants may feel uncomfortable answering certain questions about their health during the study, but they will be advised that they are not obliged to answer any questions they are not comfortable with.
Where is the study run from?
1. The Royal Orthopaedic Hospital, Birmingham (UK)
2. Nuffield Orthopaedic Centre, Oxford (UK)
When is the study starting and how long is it expected to run for?
April 2015 to April 2020
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Professor Sallie Lamb
sarah.lamb@ndorms.ox.ac.uk
Contact information
Public
Centre for Rehabilitation Research in Oxford
Botnar Research Centre
University of Oxford
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
Scientific
Botnar Research Centre, University of Ox
Windmill Road, Headington
Oxford
OX3 7LD
United Kingdom
Study information
| Study design | Multi-centre randomized controlled trial |
|---|---|
| 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 | Better Outcomes for Older People with Spinal Trouble (BOOST) Randomised Controlled Trial |
| Study acronym | BOOST RCT |
| Study objectives | The aim of this study is to evaluate the clinical and cost-effectiveness of a group physiotherapy programme for people with neurogenic claudication due to spinal stenosis compared to best practice advice. |
| Ethics approval(s) | London - Brent Research Ethics Committee, 10/03/2016, ref: 16/LO/0349 |
| Health condition(s) or problem(s) studied | Neurogenic claudication, Spinal stenosis |
| Intervention | Participants are randomly allocated to one of two groups. Intervention group: Participants take part in a 12-week group physiotherapy programme comprising of a progressing exercise programme underpinned by cognitive behavioural strategies to promote engagement and adherence with the programme. Each class lasts for 1.5 hours and will involve exercises and group discussions about ways to manage symptoms and be more physically active. Control group: Participants receive one individual session to provide information about exercise and self-management with two optional follow up sessions if required. After treatment, participants will be invited to two follow-up appointments with the researcher (6 and 12 months after they join the study). They will also receive a questionnaire in the post 2 years after joining the study which we will ask them to complete and return to the BOOST Trial Team. |
| Intervention type | Behavioural |
| Primary outcome measure | Functional Disability is measured using the Oswestry Disability Index at baseline, 6, 12, 24 months. |
| Secondary outcome measures | 1. Back pain and leg symptoms is measured using the Swiss Spinal Stenosis Questionnaire (symptom subscale) at baseline, 6, 12 and 24 months 2. Physical activity is measured using Rapid Assessment Disuse Index (modified) at baseline, 6, 12 and 24 months 3. Mobility is measured using a 6 minute walk test and short physical performance battery at baseline 6, 12 and 24 months 4. Frailty, fatigue and sleep is measured using the Tilberg Frailty Index at baseline, 6, 12 and 24 months 5. Falls and falls related injuries are measured using self-report at baseline, 6, 12 and 24 months, and Short Physical Performance Battery (SPPB) at baseline. 6. Disability and health related quality of life is measured using the EQ5D-5L at baseline, 6, 12 and 24 months 7. Perceived change is measured using the Global rating of perceived change scale at 6, 12 and 24 months 8. Self-efficacy is measured using Self-efficacy recovery and maintenance related to performing home exercises and Single item from the Modified Gait Self-Efficacy Scale at baseline, 6, 12 and 24 months and the Exercise self-efficacy scale (short version) at baseline. 9. Fear avoidance is measured using the Fear avoidance beliefs questionnaire at baseline,6, 12 and 24 months 10. Habit is measured using Index of habit (short version) at 6, 12 and 24 months 11. Satisfaction with attempts to increase physical activity is measured using 5 point scale questionnaire at 6, 12 months 12. Satisfaction with treatment is measured using 5 point scale questionnaire at 6, 12 months 13. Adherence to home exercise programme is measured through self-reporting at 6, 12 months 14. Sagittal alignment of the spine is measured using occiput to wall measure at baseline,6, 12 months and MRI scan parameters at baseline. 15. Health resource use and treatment costs is measured using self-report and structured interview at 6, 12 months. 16. Other pain measured by Nordic pain questionnaire at baseline and 24 months. |
| Overall study start date | 01/04/2015 |
| Completion date | 29/08/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | A minimum of 402 participants will be recruited into the RCT. |
| Total final enrolment | 435 |
| Key inclusion criteria | 1. Aged 65 years and over 2. Registered with a primary care practice 3. Living in the community, including sheltered or supported housing 4. Willing and able to give informed consent for participation in the trial 5. Reports symptoms consistent with neurogenic claudication |
| Key exclusion criteria | 1. Living in a residential care or nursing home 2. Has a terminal condition with a life expectancy of less than 6 months 3. Any substantial health or social concern that, in the opinion of the patient’s general practitioner, would place the patient at increased risk or inability to participate including known inability to provide informed consent e.g. Dementia 4. Unable to walk 3 meters without the help of another person 5. On a surgical waiting list 6. Presents with cauda equina syndrome or signs of serious pathology requiring immediate referral for investigations 7. Cognitive impairment (defined as an Abbreviated Mental Test score of 6 or less) 8. Registered blind 9. Unable to follow verbal instructions which would make participation in the exercise group impractical including severe hearing impairment not corrected by a hearing aid or inability to follow simple safety instructions (eg English comprehension) |
| Date of first enrolment | 25/07/2016 |
| Date of final enrolment | 29/08/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Bristol Road South
Northfield
Birmingham
B31 2AP
United Kingdom
Windmill Road
Oxford
OX3 7HE
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
England
United Kingdom
"ROR" |
https://ror.org/03h2bh287 |
|---|
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 | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results of the trial will be reported first to trial collaborators. The main report will be drafted by the research team and subject to external peer review prior to publication. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Findings from the research will be disseminated at conferences and via a dedicated website. A summary of the study outcomes will also be available to study participants on relevant websites and directly circulated by way of study newsletters. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/10/2018 | 30/10/2019 | Yes | No |
| Statistical Analysis Plan | statistical analysis plan | 21/07/2020 | 24/07/2020 | No | No |
| Protocol article | protocol for causal mediation analysis | 02/09/2020 | 07/09/2020 | Yes | No |
| Other publications | 14/09/2022 | 15/09/2022 | Yes | No | |
| Results article | 12/08/2022 | 30/09/2022 | Yes | No | |
| Other publications | Economic evaluation | 08/02/2023 | 10/02/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Development and delivery of the BOOST intervention | 07/02/2019 | 06/06/2024 | Yes | No |
| Results article | 01/12/2023 | 06/06/2024 | Yes | No | |
| Other publications | A causal mediation analysis | 20/06/2025 | 24/06/2025 | Yes | No |
Editorial Notes
24/06/2025: Publication reference added.
06/06/2024: Publication references added.
10/02/2023: Publication reference and total final enrolment added.
30/09/2022: Publication reference added.
15/09/2022: Publication reference added.
07/09/2020: Publication reference added.
24/07/2020: Publication reference added.
30/10/2019: Publication reference added.
18/10/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 01/04/2021 to 29/08/2020
2. The total target enrolment has been updated from 402 to 438
3. The recruitment end date was changed from 30/09/2018 to 29/08/2018
23/07/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2018 to 30/09/2018.
2. The overall trial end date was changed from 01/04/2020 to 01/04/2021.
3. The intention to publish date was changed from 31/12/2020 to 31/12/2021.
22/12/2017: The following changes were made:
1. Angela Garrett replaced Frances Darton as the primary study contact.
2. The recruitment start date was changed from 01/02/2016 to 25/07/2016.
3. The recruitment end date was changed from 01/08/2017 to 30/06/2018.
