Personalized Trial for Chronic Lower Back Pain

February 1, 2021 updated by: Karina Davidson, Northwell Health

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean System Usability Score
Time Frame: Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Participant Satisfaction with Personalized Trials Components
Time Frame: Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion
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
Time Frame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
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
Time Frame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
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
Time Frame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
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
Time Frame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
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
Time Frame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
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
Time Frame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6
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
Time Frame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks.
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
Time Frame: From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings