Last updated: December 7, 2020
Sponsor: Kaia Health Software
Overall Status: Active - Enrolling
Phase
N/A
Condition
Chronic Pain
Treatment
N/AClinical Study ID
NCT04290078
KaiaBP001
Ages 21-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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, inthe week prior to screening
- Low back pain diagnosis with duration ≥1 month and <12 months (i.e., non-specificsubacute or chronic back pain)
- Willingness and capable of providing Informed Consent to use the Kaia Study app andparticipate in all assessments associated with this clinical study
Exclusion
Exclusion Criteria:
- Referral or plans for surgery, chiropractic care, acupuncture, injections or othertreatment for low back pain in the next 1 month following screening
- Self-reported prior subscription to Kaia app or plans to participate in any otherinvestigational 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 backpain
- Self-reported ongoing use of opioids for conditions other than back pain within 30days prior to screening
- If taking opioid or NSAID medication for back pain, changes in dosing or type ofmedications 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 daywithin 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, activeinfection, stroke with residual neuromuscular effects, paralysis, gait imbalance, orhistory of recent recurrent falls)
Study Design
Total Participants: 184
Study Start date:
December 01, 2020
Estimated Completion Date:
August 01, 2021
Study Description
Connect with a study center
Brigham and Women's Hospital /Physiatry, Spine & Pain Management
Boston, Massachusetts 02115
United StatesSite Not Available
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