Contact information
Type
Scientific
Primary contact
Prof Philip Conaghan
ORCID ID
Contact details
Academic Unit of Musculoskeletal Disease
2nd Floor
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
+44 (0)113 392 4884
p.conaghan@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18183
Study information
Scientific title
Physiotherapy for neurogenic claudication: a randomised trial of older adults in a primary care-based physiotherapy service
Acronym
Study hypothesis
Condition-specific physiotherapy rehabilitation is more effective than advice and education alone in the treatment of neurogenic claudication.
Ethics approval
Ethics approval received from the Leeds Central Ethics Committee on the 22nd February 2008 (ref: 08/H1313/1).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
02/04/2008
Overall trial end date
31/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
76
Participant 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)
Recruitment start date
02/04/2008
Recruitment end date
31/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Unit of Musculoskeletal Disease
Leeds
LS7 4SA
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
c/o Clare Skinner
Faculty of Medicine & Health Research Manager
Research Support Unit
3 Cavendish Road
Leeds
LS2 9JT
United Kingdom
+44 (0)113 343 4897
c.e.skinner@leeds.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Arthritis Reseach Campaign (ARC) (UK) (grant ref: 18183)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24098633
Publication citations
-
Results
Comer C, Redmond AC, Bird HA, Hensor EM, Conaghan PG, A home exercise programme is no more beneficial than advice and education for people with neurogenic claudication: results from a randomised controlled trial., PLoS ONE, 2013, 8, 9, e72878, doi: 10.1371/journal.pone.0072878.