Personalized Trial for Chronic Lower Back Pain

Northwell Health

Status: Completed

Conditions: Back Pain Lower Back Chronic

Treatments: Other: Swedish Massage; Other: Yoga

Study type: Interventional

Funder types: Other

Identifiers

NCT04203888

19-0672

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

Massage

Other group

Description:

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.

Treatment:

Other: Swedish Massage

Yoga

Other group

Description:

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.

Treatment:

Other: Yoga

Usual Care

No Intervention group

Description:

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.