Personalized Trial for Chronic Lower Back Pain
Completed · Not applicable
Conditions studied: Back Pain Lower Back Chronic
In brief
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.
Key facts
- Study ID
- NCT04203888
- Run by
- Northwell Health
- People needed
- 57
- Starts
- 2019-11-20
- Expected to finish
- 2021-01-31
- Last updated by the study team
- 2021-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Center for Personalized Health — New York, New York, United States
Full record on ClinicalTrials.gov
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