Clinical trial NCT04290078: The Kaia Back Pain Intervention for Self-management of Low Back Pain
Official title: The Kaia Back Pain Intervention for Self-management of Low Back Pain - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Kaia Health Software
Sponsor class: INDUSTRY
Collaborators: name: Brigham and Women's Hospital
First posted: 2020-02-28
Enrollment: 184
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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, in the week prior to screening
5. Low back pain diagnosis with duration ≥1 month and \<12 months (i.e., non-specific subacute or chronic back pain)
6. Willingness and capable of providing Informed Consent to use the Kaia Study app and participate in all assessments associated with this clinical study

Exclusion Criteria:

1. Referral or plans for surgery, chiropractic care, acupuncture, injections or other treatment 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 other investigational 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 back pain
5. Self-reported ongoing use of opioids for conditions other than back pain within 30 days prior to screening
6. 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
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 day within 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, active infection, stroke with residual neuromuscular effects, paralysis, gait imbalance, or history of recent recurrent falls)

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: Change from baseline NRS at 90 days
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: baseline (day 0), day 30, day 60 and day 90
measure: Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10)
timeFrame: baseline (day 0), day 30, day 60 and day 90
measure: Perceived Treatment Helpfulness
timeFrame: baseline (day 0), day 30, day 60 and day 90
measure: Pain Catastrophizing Scale
timeFrame: baseline (day 0) and at day 90
measure: Satisfaction and perceived treatment helpfulness
timeFrame: Study End at day 90
measure: Health care utilisation
timeFrame: baseline (day 0), day 30, day 60 and day 90
measure: Change in concomitant medication use
timeFrame: baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90
measure: Number of Adverse Events
timeFrame: baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90
measure: Number of Device Deficiencies
timeFrame: baseline (day 0), day 15, day 30, day 45, day 60, day 75 and day 90
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital /Physiatry, Spine & Pain Management
state: Massachusetts
Study officials:
affiliation: Physiatry, Spine & Pain Management
name: Assoc. Prof. Srdjan Nedeljkovic, MD
role: PRINCIPAL_INVESTIGATOR
References: