Developing better care for the elderly patients with walking disability due to degenerative lumbar spine stenosis

ISRCTN ISRCTN35836727
DOI https://doi.org/10.1186/ISRCTN35836727
Secondary identifying numbers N0626176966
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
06/01/2021
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

Miss Christine Comer
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDeveloping better care for the elderly patients with walking disability due to degenerative lumbar spine stenosis
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Degenerative lumbar spine stenosis
InterventionWalking tolerance will be measured with and without a stick.
Intervention typeOther
Primary outcome measureShuttle 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 measuresNot provided at time of registration
Overall study start date01/01/2006
Completion date01/09/2008

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants20
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2006
Date of final enrolment01/09/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Wharfedale Hospital
Otley
LS21 2LY
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Bradford South and West Primary Care Trust (UK), NHS R&D Support Funding

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 06/01/2021 Yes No

Editorial Notes

06/01/2021: Publication reference added.