Personalized Trial for Chronic Lower Back Pain

Re-engineering Precision Therapeutics Through N-of-1 Trials

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.

Study Overview

• Status: Completed
• Conditions: Back Pain Lower Back Chronic
• Intervention / Treatment: Other: Swedish Massage; Other: Yoga

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Center for Personalized Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Other: 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.
OTHER: 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.	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).; Other Names: Viniyoga
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Participant Satisfaction with Personalized Trials Components	Participant satisfaction rated on a 5-point Likert scale from Very Dissatisfied (1) to Very Satisfied (5), or Strongly Disagree (1) to Strongly Agree (5). Higher scores correlate to greater satisfaction, and therefore a better outcome.	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	Pain intensity is measured using the PROMIS Scale v1.0 - Pain Intensity 3a Fixed Length Short Form. The measure is modified from instructions to recall over the last 7 days to recall over the last 24 hours. Raw scores will be converted to an item response theory-based T-score using the PROMIS scoring manual. A T-score of 50 is the average for the US general population with an SD of 10. A higher T-score represents higher pain intensity or interference.	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	Pain interference is measured using a PROMIS Short Form v1.0 - Pain Interference 4a Fixed Length Short Form. The measure is modified from instructions to recall over the last 7 days to recall over the last 24 hours. Raw scores will be converted to an item response theory-based T-score using the PROMIS scoring manual. A T-score of 50 is the average for the US general population with an SD of 10. A higher T-score represents higher pain intensity or interference.	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	Numeric Pain Rating Scale adapted from McCaffery, Beebe et al. 1989 Numeric Pain Rating Scale, assessing current Pain level on a scale from 0 (none) to 10 (severe). Higher scores correlate to a worse outcome.	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	Numeric Fatigue Rating Scale adapted from McCaffery, Beebe et al. 1989, assessing current Fatigue level on a scale from 0 (none) to 10 (severe). Higher scores correlate to a worse outcome.	From 2-Week Treatment Period 1 to 2-week Treatment Period 6
Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Stress During 3 Treatment Periods from Mean Baseline	Numeric Stress Rating Scale adapted from McCaffery, Beebe et al. 1989, assessing current Stress level on a scale from 0 (none) to 10 (severe). Higher scores correlate to a worse outcome.	From 2-Week Treatment Period 1 to 2-week Treatment Period 6
Mean Within-Subject Difference in Self-Reported Use of Pain Medication from Baseline	Average number of pain medication pills self-reported by participants as taken to manage their back pain. Daily question to quantify how many pain pills taken in the last 24 hours, and of what type and dosage.	From 2-Week Treatment Period 1 to 2-week Treatment Period 6
Mean Within-Subject Difference in Device-Recorded Daily Steps from Mean Baseline	Average participant daily step data, as recorded by a Fitbit Charge 3 device.	From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks.
Mean Within-Subject Difference in Device-Recorded Nightly Sleep from Mean Baseline	Average participant sleep minutes and sleep stage minute estimates, as recorded by a Fitbit Charge 3 device.	From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks.

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2019
• Primary Completion (ACTUAL): January 31, 2021
• Study Completion (ACTUAL): January 31, 2021

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (ACTUAL): December 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Feasibility; Pain; Yoga; Low Back Pain; Personalized; N-of-1; Virtual; Massage; Lower Back Pain; Personalized Trial; Swedish Massage
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 19-0672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary. Pooling N-of-1 trials together is a more efficient approach to deriving population-level estimates than conventional randomized controlled trials.
• IPD Sharing 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.
• IPD Sharing Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No