Personalized Trial for Chronic Lower Back Pain

NCT04203888 | Completed DMC

• 1 other identifier: 19-0672
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain Lower Back Chronic

Keywords

N-of-1; Yoga; Massage; Pain; Low Back Pain; Lower Back Pain; Virtual; Swedish Massage; Personalized Trial; Personalized; Feasibility

Outcome Measures

Primary Outcomes (1)

• Mean System Usability Score

  Usability of the Personalized Trials platform will be evaluated using the System Usability Scale (SUS), a 10-item questionnaire created by Digital Equipment Co Ltd. and John Brooke in 1986 that asks users to score each item on a Likert scale from Strongly Disagree (1) to Strongly Agree (5). Individual results are calculated to arrive at a composite measure out of 100. Participant SUS scores will be averaged together. Higher scored values correlate to a more usable system, and therefore a better outcome.

  Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion

Secondary Outcomes (9)

• Mean Participant Satisfaction with Personalized Trials Components

  Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion

• Mean Within-Subject Difference in Self-Reported Daily Pain Intensity During 3 Treatment Periods from Mean Baseline

  From 2-Week Treatment Period 1 to 2-week Treatment Period 6

• Mean Within-Subject Difference in Self-Reported Daily Pain Interference During 3 Treatment Periods from Mean Baseline

  From 2-Week Treatment Period 1 to 2-week Treatment Period 6

• Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Pain During 3 Treatment Periods from Mean Baseline

  From 2-Week Treatment Period 1 to 2-week Treatment Period 6

• Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Fatigue During 3 Treatment Periods from Mean Baseline

  From 2-Week Treatment Period 1 to 2-week Treatment Period 6

Study Arms (3)

Massage

OTHER

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.

Other: Swedish Massage

Yoga

OTHER

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.

Other: Yoga

Usual Care

NO 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.

Interventions

Swedish Massage 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.

Massage

Yoga 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).

Also known as: Viniyoga

Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Center for Personalized Health

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Pain; Low Back Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Karina W Davidson, PhD, MASc

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Vice President of Research

Model Details: This study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: December 18, 2019
• Study Start: November 20, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form before the first participant is randomized into the study. De-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.
• Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.

Locations

US (1)