Clinical trial NCT04203888: Personalized Trial for Chronic Lower Back Pain
Official title: Re-engineering Precision Therapeutics Through N-of-1 Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Mean System Usability Score
timeFrame: Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion
Secondary outcomes:
measure: Mean Participant Satisfaction with Personalized Trials Components
timeFrame: Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion
measure: Mean Within-Subject Difference in Self-Reported Daily Pain Intensity During 3 Treatment Periods from Mean Baseline
timeFrame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
measure: Mean Within-Subject Difference in Self-Reported Daily Pain Interference During 3 Treatment Periods from Mean Baseline
timeFrame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
measure: Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Pain During 3 Treatment Periods from Mean Baseline
timeFrame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
measure: Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Fatigue During 3 Treatment Periods from Mean Baseline
timeFrame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
measure: Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Stress During 3 Treatment Periods from Mean Baseline
timeFrame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
measure: Mean Within-Subject Difference in Self-Reported Use of Pain Medication from Baseline
timeFrame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
measure: Mean Within-Subject Difference in Device-Recorded Daily Steps from Mean Baseline
timeFrame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks.
measure: Mean Within-Subject Difference in Device-Recorded Nightly Sleep from Mean Baseline
timeFrame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks.
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Personalized Health
state: New York
Study officials:
affiliation: Northwell Health
name: Karina W Davidson, PhD, MASc
role: PRINCIPAL_INVESTIGATOR
References: