Personalized Trial for Chronic Lower Back Pain

NCT ID: NCT04203888

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2021-01-31

Brief 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.

Detailed Description

The Personalized Trial of Chronic Lower Back Pain will facilitate remote N-of-1 interventions to research participants with self-identified back pain persisting longer than 12 weeks. Participants will be randomized in a multiple crossover design to receive Swedish massage in-home by a commercial wellness service, yoga instruction in-home by a commercial wellness service, and no intervention/usual care. Participants will evaluate their pain intensity, pain interference, fatigue and stress daily through self-reported questionnaires. Online screening and enrollment methods, text-message reminders and questionnaire prompts, and wearable devices will be employed to collect data. At the end of the study, participants will receive a personalized report summarizing their observed data in each treatment period. Participants will evaluate the system usability of Personalized Trials, will debrief their experience with a member of the research team, and will share their overall satisfaction with Personalized Trials.

Conditions

Back Pain Lower Back Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Massage

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 Type: OTHER

Swedish Massage

Intervention Type: OTHER

60-minute Swedish Massage delivered in-home by a licensed massage therapist, 2 times per week with at least 48-hours between massage interventions.

Yoga

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 Type: OTHER

Yoga

Intervention Type: OTHER

60-minute yoga session delivered in-home by a certified yoga instructor, 2 times per week with at least 48-hours between yoga interventions.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).

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Swedish Massage

60-minute Swedish Massage delivered in-home by a licensed massage therapist, 2 times per week with at least 48-hours between massage interventions.

Intervention Type: OTHER

Yoga

60-minute yoga session delivered in-home by a certified yoga instructor, 2 times per week with at least 48-hours between yoga interventions.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).

Intervention Type: OTHER

Other Intervention Names

Viniyoga

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age
• Fluent in English
• Experiencing symptoms of low back pain for > 12 weeks
• Self-reported pain intensity > 8 on the PROMIS pain intensity scale during screening
• Able to receive massage and yoga interventions (2x/week between 8 am and 10 pm)
• Owns and can regularly access a smartphone capable of receiving text messages
• Owns and can regularly access an e-mail account

Exclusion Criteria

• Pregnant women
• History of spinal surgery
• Complex back pain (e.g. sciatica, spinal stenosis, or other pre-existing condition)
• Previous diagnosis of a serious mental health condition or psychiatric disorder
• Previous diagnosis of opioid use disorder or treatment for any substance use disorder
• Previously advised that yoga or massage is unsafe for their condition
• Current opioid use
• Current physical activity restrictions
• Planned surgery or procedures within 6 months of recruitment
• Planned travel outside the United States within treatment period time-frame
• Weight greater than or equal to 500 lbs.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Karina Davidson

Senior Vice President of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karina W Davidson, PhD, MASc

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Center for Personalized Health

New York, New York, United States

Countries

United States

Other Identifiers

19-0672

Identifier Type: -

Identifier Source: org_study_id