Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0626176966
Study information
Scientific title
Developing better care for the elderly patients with walking disability due to degenerative lumbar spine stenosis
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Musculoskeletal Diseases: Degenerative lumbar spine stenosis
Intervention
Walking tolerance will be measured with and without a stick.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Shuttle walking crossover test: difference in walking tolerance (measured in metres) between SWT with walking stick and SWT without walking stick. Each shuttle is 10 metres, thus the number of completed shuttles counted by the investigator will be multiplied by 10 to provide an outcome measure in metres.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2006
Overall trial end date
01/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients 65 and over
2. Unilateral or bilateral neurogenic claudication (NC), ie exercise induced leg pain on walking, relieved in sitting
3. Patient reported limitation of walking tolerance due to symptoms of NC
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Cognitive impairment preventing full understanding or participation in the study
2. Evidence of medical conditions such as hip/leg pathology or peripheral vascular disease, which may mimic NC or prevent participation in a shuttle walking test
3. Severe or worsening neurological status
4. Signs/symptoms of cauda equina compression, inflammatory joint disease, signs/symptoms of sinister pathology (unexplained weight loss, unremitting/night-time pain, history of cancer), which may require urgent surgical opinion. This will be determined through subjective and objective examination of patients by the recruiting researcher at the point of screening
5. Exclusion criterion for Home Trial Pilot phase only: previous use of walking aid
Recruitment start date
01/01/2006
Recruitment end date
01/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wharfedale Hospital
Otley
LS21 2LY
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bradford South and West Primary Care Trust (UK), NHS R&D Support Funding
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