The Kaia Back Pain Intervention for Self-management of Low Back Pain

Status unconfirmed · Not applicable

Conditions studied: Low Back Pain

In brief

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 low back pain based on change in pain intensity, physical functioning, quality of life (PROMIS-10) based on self-reported information from baseline to study end as compared to a control group.

Key facts

Study ID

NCT04290078

Run by

Kaia Health Software

People needed

184

Starts

2020-12-01

Expected to finish

2021-08-01

Last updated by the study team

2020-12-08

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Brigham and Women's Hospital /Physiatry, Spine & Pain Management — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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