An interventional study of Swedish Massage and Yoga in Back Pain Lower Back Chronic, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Northwell Health · Not applicable, Interventional, and Other
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 57 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
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Exclusion Criteria:
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
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
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.
60-minute Swedish Massage delivered in-home by a licensed massage therapist, 2 times per week with at least 48-hours between massage interventions.
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
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.
Time frame: Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
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