Neurogenic claudication, Spinal stenosis Nervous System Diseases Neurogenic claudication, Spinal stenosis
Conditions
Interventions
Participants are randomly allocated to one of two groups.
Intervention group: Participants take part in a 12-week group physiotherapy programme comprising of a progressing exercise programme underpin
Sponsors
Oxford University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 65 years and over 2. Registered with a primary care practice 3. Living in the community, including sheltered or supported housing 4. Willing and able to give informed consent for participation in the trial 5. Reports symptoms consistent with neurogenic claudication
Exclusion criteria
Exclusion criteria: 1. Living in a residential care or nursing home 2. Has a terminal condition with a life expectancy of less than 6 months 3. Any substantial health or social concern that, in the opinion of the patient’s general practitioner, would place the patient at increased risk or inability to participate including known inability to provide informed consent e.g. Dementia 4. Unable to walk 3 meters without the help of another person 5. On a surgical waiting list 6. Presents with cauda equina syndrome or signs of serious pathology requiring immediate referral for investigations 7. Cognitive impairment (defined as an Abbreviated Mental Test score of 6 or less) 8. Registered blind 9. Unable to follow verbal instructions which would make participation in the exercise group impractical including severe hearing impairment not corrected by a hearing aid or inability to follow simple safety instructions (eg English comprehension)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Disability is measured using the Oswestry Disability Index at baseline, 6, 12, 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Back pain and leg symptoms is measured using the Swiss Spinal Stenosis Questionnaire (symptom subscale) at baseline, 6, 12 and 24 months 2. Physical activity is measured using Rapid Assessment Disuse Index (modified) at baseline, 6, 12 and 24 months 3. Mobility is measured using a 6 minute walk test and short physical performance battery at baseline 6, 12 and 24 months 4. Frailty, fatigue and sleep is measured using the Tilberg Frailty Index at baseline, 6, 12 and 24 months 5. Falls and falls related injuries are measured using self-report at baseline, 6, 12 and 24 months, and Short Physical Performance Battery (SPPB) at baseline. 6. Disability and health related quality of life is measured using the EQ5D-5L at baseline, 6, 12 and 24 months 7. Perceived change is measured using the Global rating of perceived change scale at 6, 12 and 24 months 8. Self-efficacy is measured using Self-efficacy recovery and maintenance related to performing home exercises and Single item from the Modified Gait Self-Efficacy Scale at baseline, 6, 12 and 24 months and the Exercise self-efficacy scale (short version) at baseline. 9. Fear avoidance is measured using the Fear avoidance beliefs questionnaire at baseline,6, 12 and 24 months 10. Habit is measured using Index of habit (short version) at 6, 12 and 24 months 11. Satisfaction with attempts to increase physical activity is measured using 5 point scale questionnaire at 6, 12 months 12. Satisfaction with treatment is measured using 5 point scale questionnaire at 6, 12 months 13. Adherence to home exercise programme is measured through self-reporting at 6, 12 months 14. Sagittal alignment of the spine is measured using occiput to wall measure at baseline,6, 12 months and MRI scan parameters at baseline. 15. Health resource use and treatment costs is measured using self-report and structured interview at 6, 12 months. 16. Other pain measured by Nordic pain questionnaire at baseline and 24 months. | — |
Countries
England, United Kingdom
Contacts
Public ContactAngela Garrett
Outcome results
None listed