Neurogenic claudication physiotherapy trial
| ISRCTN | ISRCTN78288224 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78288224 |
| Secondary identifying numbers | 18183 |
- Submission date
- 01/04/2008
- Registration date
- 26/06/2008
- Last edited
- 08/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Philip Conaghan
Scientific
Scientific
Academic Unit of Musculoskeletal Disease
2nd Floor, Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
| Phone | +44 (0)113 392 4884 |
|---|---|
| p.conaghan@leeds.ac.uk |
Study information
| Study design | Randomised 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 below to request a patient information sheet |
| Scientific title | Physiotherapy for neurogenic claudication: a randomised trial of older adults in a primary care-based physiotherapy service |
| Study objectives | Condition-specific physiotherapy rehabilitation is more effective than advice and education alone in the treatment of neurogenic claudication. |
| Ethics approval(s) | Ethics approval received from the Leeds Central Ethics Committee on the 22nd February 2008 (ref: 08/H1313/1). |
| Health condition(s) or problem(s) studied | Degenerative lumbar spinal stenosis |
| Intervention | Advice/education-only arm: Receive a one-off treatment session consisting of advice and education about lumbar spinal stenosis (pathology, diagnosis, prognosis, management) based on patient information provided by the American Rheumatology Society. Telephone access to a physiotherapist for advice will be available if needed over subsequent 6 weeks. Advice/education plus physiotherapy rehabilitation: As above plus between 4 and 6 sessions with a physiotherapist over subsequent 6 week period. Treatment consisting of exercise programme (lumbar flexion, core stability, fitness exercises) to be carried out daily, monitored and adjusted by treating physiotherapist. |
| Intervention type | Other |
| Primary outcome measure | Swiss Spinal Stenosis Score (Zurich Claudication Score) symptom severity scale at eight weeks. |
| Secondary outcome measures | At twelve months follow-up: 1. Oswestry Disability Index 2. Visual Analogue Pain Scale (VAS) 3. General Well-Being Index |
| Overall study start date | 02/04/2008 |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 76 |
| Key inclusion criteria | 1. Patients aged 50 or over, either sex 2. Symptoms of neurogenic claudication (walking-induced lower limb symptoms which are relieved in sitting/flexion) 3. Limitation of normal walking tolerance due to symptoms of neurogenic claudication |
| Key exclusion criteria | 1. Clearly defined radicular symptoms (sciatica) 2. Cognitive impairment or medical conditions preventing understanding or participation in trial 3. Symptoms requiring urgent surgical or other intervention (red flags, such as acute equina syndrome) |
| Date of first enrolment | 02/04/2008 |
| Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Unit of Musculoskeletal Disease
Leeds
LS7 4SA
United Kingdom
LS7 4SA
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
c/o Clare Skinner
Faculty of Medicine & Health Research Manager
Research Support Unit
3 Cavendish Road
Leeds
LS2 9JT
England
United Kingdom
| Phone | +44 (0)113 343 4897 |
|---|---|
| c.e.skinner@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
Arthritis Reseach Campaign (ARC) (UK) (grant ref: 18183)
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 | 30/09/2013 | Yes | No |
