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

Last updated: December 7, 2020
Sponsor: Kaia Health Software
Overall Status: Active - Enrolling

Phase

N/A

Condition

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT04290078
KaiaBP001
  • Ages 21-75
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Between 22 and 75 years old
  2. Able to speak, read, and understand English
  3. Smartphone user with a compatible device, built-in camera, and internet access at home
  4. Pain intensity ≥4/10 on Numeric Rating Scale (NRS) for low back pain, on average, inthe week prior to screening
  5. Low back pain diagnosis with duration ≥1 month and <12 months (i.e., non-specificsubacute or chronic back pain)
  6. 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:

  1. Referral or plans for surgery, chiropractic care, acupuncture, injections or othertreatment for low back pain in the next 1 month following screening
  2. Self-reported prior subscription to Kaia app or plans to participate in any otherinvestigational trials or protocols for low back pain within 90 days
  3. Known pregnancy at screening or plans to become pregnant during study.
  4. Prior back surgery or current workers compensation case or litigation related to backpain
  5. Self-reported ongoing use of opioids for conditions other than back pain within 30days prior to screening
  6. 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
  7. 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
  8. Self-reported history of substance abuse within 1 year
  9. Diagnosis of specific underlying cause of back pain (e.g., known spinal fracture,spinal tumor, spinal infection, disc herniation, spinal stenosis)
  10. 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

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 without restrictions on treatment). It is designed to enroll up to 184 participants. The treatment period will last for 90 days. This includes the randomization assignment and follow-up evaluations at 30 days, 60 days, and 90 days post-randomization. After pre-screening and informed consent activities are completed, the study will be conducted using electronic patient reported outcomes (ePROs); participants can complete all study tasks at home by means of internet-enabled devices. Participants assigned to the intervention group will implement Kaia's exercise regimen using their personal mobile devices. The control group will receive usual care without restrictions and will be provided with internet-based information about treatment of non-specific back pain, including handouts depicting typical home-based exercises as recommended by American Academy of Orthopedic Surgeons.

Connect with a study center

  • Brigham and Women's Hospital /Physiatry, Spine & Pain Management

    Boston, Massachusetts 02115
    United States

    Site Not Available

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