Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
19/08/2015
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

Miss Christine Comer

ORCID ID

Contact details

Physiotherapy Department
Wharfedale Hospital
Newall Carr Road
Otley
LS21 2LY
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes