Low Back Pain Clinical Trial
— PAESPOfficial title:
Physical Activity in the Elderly Spine Patient
Verified date | March 2023 |
Source | Spine Centre of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Purpose Physical activity reduces the risk of several diseases of the body and the mind1, 2 and can help the elderly maintain physical abilities and self-efficacy in daily life1. The overall purpose of the project is to provide clinicians with a tool to objectively assess physical activity in daily life and thus provide an informed basis for individualized care of elderly patients with spine disease. We would like to introduce this tool to a broad population of elderly patients with low back pain to give an overview of the range and variability in physical activity. We will also look into a method for accurate step count in spine disorders where patients have severe walking impairment due to affected lumbar nerve roots.
Status | Completed |
Enrollment | 206 |
Est. completion date | February 1, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria for Patients with LSS: - Informed written consent. - Fluent in Danish in reading and speaking. - Age >60 with LSS, +/- spondylolisthesis diagnosed via clinical examination and MRI. Suffering from neurogenic claudication with positive answers to a set of six items characteristic to LSS[29]. - Patients in phase A will be included to represent a spectrum of severeness of LSS and age. Severeness will be evaluated by ODI score, VAS and self-reported maximum walking distance. - Patients for phase C will have the additional inclusion criteria of being scheduled for decompressive surgery. Exclusion Criteria: - Other disease limiting walking rather than neurogenic claudication, such as cardiopulmonary diseases, vascular claudication, recent operation or fracture of spine, pelvis or leg, severe hip or knee arthrosis (not efficiently threated by hip/knee replacement), systemic muscular diseases, impaired vision. - Traits which interfere with the participants' gait pattern, such as habitual use of walking aids during walking at home and away from home, drop foot. Eligibility Criteria for Patients with LBP: - Informed written consent. - Fluent in Danish in reading and speaking. - Age >60 - Suffering from Low Back Pain - Low Back Pain is the primary source of pain and disability. Eligibility Criteria for Healthy Participants: - Healthy participants will be >60 years old and have the same exclusion criteria as patients, with the addition of not suffering from neurogenic claudication. |
Country | Name | City | State |
---|---|---|---|
Denmark | Spine Centre of Southern Denmark | Middelfart |
Lead Sponsor | Collaborator |
---|---|
Malin Eleonora av Kák Gustafsson, MD | University of Southern Denmark |
Denmark,
Ammendolia C, Stuber K, Tomkins-Lane C, Schneider M, Rampersaud YR, Furlan AD, Kennedy CA. What interventions improve walking ability in neurogenic claudication with lumbar spinal stenosis? A systematic review. Eur Spine J. 2014 Jun;23(6):1282-301. doi: 10.1007/s00586-014-3262-6. Epub 2014 Mar 15. — View Citation
Dijkstra B, Kamsma Y, Zijlstra W. Detection of gait and postures using a miniaturised triaxial accelerometer-based system: accuracy in community-dwelling older adults. Age Ageing. 2010 Mar;39(2):259-62. doi: 10.1093/ageing/afp249. Epub 2010 Jan 18. No abstract available. — View Citation
Henrica C. W. de Vet CBT, Lidwine B. Mokkink, Dirk L. Knol (2011) Measurement in Medicine A Practical Guide
Jespersen AB, Gustafsson MEAK. Correlation between the Oswestry Disability Index and objective measurements of walking capacity and performance in patients with lumbar spinal stenosis: a systematic literature review. Eur Spine J. 2018 Jul;27(7):1604-1613. doi: 10.1007/s00586-018-5520-5. Epub 2018 Mar 5. — View Citation
Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234. — View Citation
McCullagh R, Dillon C, O'Connell AM, Horgan NF, Timmons S. Step-Count Accuracy of 3 Motion Sensors for Older and Frail Medical Inpatients. Arch Phys Med Rehabil. 2017 Feb;98(2):295-302. doi: 10.1016/j.apmr.2016.08.476. Epub 2016 Sep 22. — View Citation
Norden J, Smuck M, Sinha A, Hu R, Tomkins-Lane C. Objective measurement of free-living physical activity (performance) in lumbar spinal stenosis: are physical activity guidelines being met? Spine J. 2017 Jan;17(1):26-33. doi: 10.1016/j.spinee.2016.10.016. Epub 2016 Oct 25. — View Citation
Park J, Ishikawa-Takata K, Tanaka S, Bessyo K, Tanaka S, Kimura T. Accuracy of Estimating Step Counts and Intensity Using Accelerometers in Older People With or Without Assistive Devices. J Aging Phys Act. 2017 Jan;25(1):41-50. doi: 10.1123/japa.2015-0201. Epub 2016 Aug 24. — View Citation
Tomkins CC, Battie MC, Rogers T, Jiang H, Petersen S. A criterion measure of walking capacity in lumbar spinal stenosis and its comparison with a treadmill protocol. Spine (Phila Pa 1976). 2009 Oct 15;34(22):2444-9. doi: 10.1097/BRS.0b013e3181b03fc8. — View Citation
Treacy D, Hassett L, Schurr K, Chagpar S, Paul SS, Sherrington C. Validity of Different Activity Monitors to Count Steps in an Inpatient Rehabilitation Setting. Phys Ther. 2017 May 1;97(5):581-588. doi: 10.1093/ptj/pzx010. — View Citation
Webber SC, St John PD. Comparison of ActiGraph GT3X+ and StepWatch Step Count Accuracy in Geriatric Rehabilitation Patients. J Aging Phys Act. 2016 Jul;24(3):451-8. doi: 10.1123/japa.2015-0234. Epub 2016 Jan 11. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accelerometer-data | Raw accelerometer data will be collected by four accelerometers (Axivity AX3. ), which will be placed at the participants' hip in the midaxillary line, at the thigh, ankle and on the lower back, secured by hypo-allergenic band aids. | Collected during the Standardized Movement Protocol at baseline. | |
Primary | Accelerometer-data | Raw accelerometer data collected for 7 consecutive days, by one accelerometer (Axivity AX3) secured by band-aid. The placement of the accelerometer will be decided in phase A. | At baseline | |
Primary | Accelerometer-data | Raw accelerometer data collected for 7 consecutive days, by one accelerometer (Axivity AX3) secured by band-aid. The placement of the accelerometer will be decided in phase A. | 3 months post-surgery | |
Primary | The Self-Paced Walking Test | Walking on a pre-determined rute until stopped by symptoms of LSS. Recording time and distance walked. | At baseline as part of the Standardized Movement Procotol | |
Primary | The Self-Paced Walking Test | Walking on a pre-determined rute until stopped by symptoms of LSS. Recording time and distance walked. | At baseline | |
Primary | The Self-Paced Walking Test | Walking on a pre-determined rute until stopped by symptoms of LSS. Recording time and distance walked. | 3 months post-surgery | |
Primary | The Oswestry Disability Index | Questionnaire on function in patients with lower back pain. Score 0-100% where 100% is severe disability | At baseline | |
Primary | The Oswestry Disability Index | Questionnaire on function in patients with lower back pain. Score 0-100% where 100% is severe disability | 3 months post-surgery. | |
Secondary | The Swiss Spinal Stenosis Questionnaire | Questionnaire on function in patients with spinal stenosis. Score 0-100% where 100% indicates severe disability. | At baseline | |
Secondary | The Swiss Spinal Stenosis Questionnaire | Questionnaire on function in patients with spinal stenosis. Score 0-100% where 100% indicates severe disability. | 3 months post-surgery | |
Secondary | Visual Analog Scale for Back and Leg Pain | Scale from 0-100. 100 indicating worse pain ever experienced. | At baseline | |
Secondary | Visual Analog Scale for Back and Leg Pain | Scale from 0-100. 100 indicating worse pain ever experienced. | 3 months post-surgery | |
Secondary | Hospital Anxiety and Depression Scale | Questionnaire on anxiety and depression. Rating anxiety and depression seperately on an ordinal scale from 0-21, 21 indicating worst result. | At baseline | |
Secondary | Hospital Anxiety and Depression Scale. Rating anxiety and depression seperately on an ordinal scale from 0-21, 21 indicating worst result. | Questionnaire on anxiety and depression | 3 months post-surgery | |
Secondary | Mean Change from Baseline in Accelerometer Measures at 3 Months Post-Surgery | Axivity AX3 secured by band-aids | 3-months post-surgery | |
Secondary | Mean Change from Baseline in The Self-Paced Walking Test at 3 Months Post-Surgery | Walking on a pre-determined rute until stopped by symptoms of LSS. Recording time and distance walked. | 3 months post-surgery | |
Secondary | Mean Change from Baseline in The Oswestry Disability Index at 3 months Post-Surgery | Questionnaire on function in patients with lower back pain | 3 months post-surgery | |
Secondary | Mean Change from Baseline in The Swiss Spinal Stenosis Questionnaire at 3 Months Post-Surgery | Questionnaire on function in patients with spinal stenosis | 3 months post-surgery |
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