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

Academic Unit of Musculoskeletal Disease
2nd Floor, Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom

Phone +44 (0)113 392 4884
Email p.conaghan@leeds.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePhysiotherapy for neurogenic claudication: a randomised trial of older adults in a primary care-based physiotherapy service
Study objectivesCondition-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) studiedDegenerative lumbar spinal stenosis
InterventionAdvice/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 typeOther
Primary outcome measureSwiss Spinal Stenosis Score (Zurich Claudication Score) symptom severity scale at eight weeks.
Secondary outcome measuresAt twelve months follow-up:
1. Oswestry Disability Index
2. Visual Analogue Pain Scale (VAS)
3. General Well-Being Index
Overall study start date02/04/2008
Completion date31/03/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants76
Key inclusion criteria1. 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 criteria1. 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 enrolment02/04/2008
Date of final enrolment31/03/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Unit of Musculoskeletal Disease
Leeds
LS7 4SA
United Kingdom

Sponsor information

University of Leeds (UK)
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
Email c.e.skinner@leeds.ac.uk
Website http://www.leeds.ac.uk/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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