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Behavioural Intervention
Yoga for Chronic Lower Back Pain
N/A
Waitlist Available
Led By Karina W Davidson, PhD, MASc
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 2-week treatment period 1 to 2-week treatment period 6
Awards & highlights
Summary
The Personalized Trial of Chronic Lower Back Pain will test the feasibility of employing technology to facilitate remote N-of-1 interventions to research participants with self-identified back pain. Participants will spend 14 weeks alternating between massage, yoga, and usual care methods to treat their back pain, while answering daily questions and wearing an activity tracker. After 14 weeks, participants will have the ability to share their opinions about a Personalized Trials platform. We believe a Personalized Trials platform will be satisfactory to participants and feasible to scale to large randomized controlled trials, and eventually to clinical practice.
Eligible Conditions
- Chronic Lower Back Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 2-week treatment period 1 to 2-week treatment period 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 2-week treatment period 1 to 2-week treatment period 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean System Usability Score
Secondary outcome measures
Mean Participant Satisfaction with Personalized Trials Components
Mean Within-Subject Difference in Device-Recorded Daily Steps from Mean Baseline
Mean Within-Subject Difference in Device-Recorded Nightly Sleep from Mean Baseline
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: YogaExperimental Treatment1 Intervention
A certified yoga instructor will deliver 60-minute yoga instruction in the participant's home, 2 times per week with at least 48-hours between yoga session. Yoga sessions will be based on the yoga postures available in the appendix of the December 2005 Annals of Internal Medicine article, "Comparing Yoga, Exercise, and a Self-Care Book for Chronic Low Back Pain" (Sherman KJ et al., 2005). Each yoga arm will be 2 weeks in length, and consist of 4 total yoga sessions.
Group II: MassageExperimental Treatment1 Intervention
A licensed massage therapist will deliver 60-minute Swedish Massage in the participant's home, 2 times per week with at least 48-hours between massage sessions. Each massage arm will be 2 weeks in length, and consist of 4 total Swedish massages.
Group III: Usual CareActive Control1 Intervention
Participants will be instructed to abstain from any massage or yoga activity, and instructed to treat their chronic lower back pain as they normally would. Each usual care arm will be 2 weeks in length.
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Who is running the clinical trial?
Northwell HealthLead Sponsor
473 Previous Clinical Trials
472,215 Total Patients Enrolled
Karina W Davidson, PhD, MAScPrincipal InvestigatorNorthwell Health
1 Previous Clinical Trials
624 Total Patients Enrolled
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