Status:
UNKNOWN
The Kaia Back Pain Intervention for Self-management of Low Back Pain
Lead Sponsor:
Kaia Health Software
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Low Back Pain
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The study aims to evaluate outcomes of the use of Kaia Study app (software program application for self-management of low-back pain) on back pain among adults with non-specific subacute and chronic lo...
Detailed Description
This is a two-arm, parallel assignment, open-label, randomized control trial comparing back pain outcomes in an intervention group (MPT using the Kaia app) to those of a control group (usual care with...
Eligibility Criteria
Inclusion
- Between 22 and 75 years old
- Able to speak, read, and understand English
- Smartphone user with a compatible device, built-in camera, and internet access at home
- Pain intensity ≥4/10 on Numeric Rating Scale (NRS) for low back pain, on average, in the week prior to screening
- Low back pain diagnosis with duration ≥1 month and \<12 months (i.e., non-specific subacute or chronic back pain)
- Willingness and capable of providing Informed Consent to use the Kaia Study app and participate in all assessments associated with this clinical study
Exclusion
- Referral or plans for surgery, chiropractic care, acupuncture, injections or other treatment for low back pain in the next 1 month following screening
- Self-reported prior subscription to Kaia app or plans to participate in any other investigational trials or protocols for low back pain within 90 days
- Known pregnancy at screening or plans to become pregnant during study.
- Prior back surgery or current workers compensation case or litigation related to back pain
- Self-reported ongoing use of opioids for conditions other than back pain within 30 days prior to screening
- If taking opioid or NSAID medication for back pain, changes in dosing or type of medications used for analgesic regimen within 30 days prior to screening
- Use of opioids greater than the following daily doses: oxycodone \>20 mg per day, morphine \> 30 mg per day, hydrocodone \> 30 mg per day, or tramadol \> 300 mg per day within 30 days prior to screening
- Self-reported history of substance abuse within 1 year
- Diagnosis of specific underlying cause of back pain (e.g., known spinal fracture, spinal tumor, spinal infection, disc herniation, spinal stenosis)
- Severe or unstable medical condition (e.g., unstable cardiac disease, active infection, stroke with residual neuromuscular effects, paralysis, gait imbalance, or history of recent recurrent falls)
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04290078
Start Date
December 1 2020
End Date
August 1 2021
Last Update
December 8 2020
Active Locations (1)
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1
Brigham and Women's Hospital /Physiatry, Spine & Pain Management
Boston, Massachusetts, United States, 02115