Personalized Trial for Chronic Lower Back Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Back Pain Lower Back Chronic

Intervention / Treatment
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* Other: Swedish Massage
* Other: Yoga


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Massage<br>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<br>* 60-minute Swedish Massage delivered in-home by a licensed massage therapist, 2 times per week with at least 48-hours between massage interventions.<br>|
| Other: Yoga<br>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<br>* 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).<br>* Other names: Viniyoga;|
| No Intervention: Usual Care<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N-of-1, Yoga, Massage, Pain, Low Back Pain, Lower Back Pain, Virtual, Swedish Massage, Personalized Trial, Personalized, Feasibility