Back Pain Lower Back ChronicNCT04203888
Personalized Trial for Chronic Lower Back Pain
A study testing Swedish Massage and Yoga in people with Back Pain Lower Back Chronic, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Swedish Massage and Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Personalized Health
New York, New York, 10022
About this study
Official title: 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.
Read the 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.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Swedish Massage, Yoga
- Keywords
- N-of-1, Yoga, Massage, Pain, Low Back Pain, Lower Back Pain, Virtual, Swedish Massage, Personalized Trial, Personalized, Feasibility
- Medical subject headings
- Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swedish MassageOther
60-minute Swedish Massage delivered in-home by a licensed massage therapist, 2 times per week with at least 48-hours between massage interventions.
YogaOther
Also called Viniyoga
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).
| Study group | Role | What they receive |
|---|---|---|
| Massage | Other | 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. Receives: Other: Swedish Massage |
| Yoga | Other | 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. Receives: Other: Yoga |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start20 Nov 2019
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karina Davidson, Northwell Health
- Investigators
- Karina W Davidson, PhD, MASc, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203888
- Sponsor's protocol ID
- 19-0672
- Status last verified
- Feb 2021
- First submitted
- 18 Nov 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-engineering Precision Therapeutics Through N-of-1 Trials
- ClinicalTrials.gov ID
- NCT04203888
- Acronym / sponsor ID
- 19-0672
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- N-of-1, Yoga, Massage, Pain, Low Back Pain, Lower Back Pain, Virtual, Swedish Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
| Arm | Type | Receives |
|---|---|---|
| Massage | Other | Other: Swedish MassageA 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. |
| Yoga | Other | Other: YogaA 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swedish Massage60-minute Swedish Massage delivered in-home by a licensed massage therapist, 2 times per week with at least 48-hours between massage interventions. | Other | Massage |
| YogaAlso: Viniyoga60-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 | Yoga |
Primary outcome
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.
9 secondary outcomes
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
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
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
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
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
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina W Davidson, PhD, MASc principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swedish Massage and Yoga in people with Back Pain Lower Back Chronic, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean System Usability Score (time frame: Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.