Condition category
Musculoskeletal Diseases
Date applied
01/04/2008
Date assigned
26/06/2008
Last edited
08/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.leeds.ac.uk/

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24098633

Publication citations

  1. 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.

Additional files

Editorial Notes