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

NCT04290078 | Unknown

• 1 other identifier: KaiaBP001
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale

  Pain Intensity (NRS-11, 0 no pain to 10 Severe pain)

  Change from baseline NRS at 90 days

Secondary Outcomes (9)

• Oswestry Disability Index

  baseline (day 0), day 30, day 60 and day 90

• Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10)

  baseline (day 0), day 30, day 60 and day 90

• Perceived Treatment Helpfulness

  baseline (day 0), day 30, day 60 and day 90

• Pain Catastrophizing Scale

  baseline (day 0) and at day 90

• Satisfaction and perceived treatment helpfulness

  Study End at day 90

Study Arms (2)

Kaia Back Pain Study Intervention

EXPERIMENTAL

The study intervention consists of training sessions conducted daily by the participant via Kaia back pain program. This content combines several approaches that may be effective when used together such as physical exercises, relaxation practices and learning modules. Additionally, there is availability of an electronic motion coach on a set of exercises. Users also receive behavioural health coaching provided by Kaia's coaching staff based on a coaching curriculum.

Device: Kaia Back Pain Study App

Control Group

ACTIVE COMPARATOR

Participants in the control arm will be provided with online links to educational materials about home exercises and pain management and asked to continue their usual care. On-line resources will include links to Web MD, the National Library of Medicine (Medline), and OnHealth.

Other: Usual Care

Interventions

Kaia Back Pain Study App DEVICE

Kaia Back Pain is an integrated solution for self-management of low-back pain that digitizes multidisciplinary rehabilitation into a smartphone application.

Kaia Back Pain Study Intervention

Usual Care OTHER

Participants in the control arm will be provided with online links to educational materials about home exercises and pain management and asked to continue their usual care. On-line resources will include links to Web MD, the National Library of Medicine (Medline), and OnHealth

Control Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Kaia Health Software: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

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

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Assoc. Prof. Srdjan Nedeljkovic, MD

  Physiatry, Spine & Pain Management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 28, 2020
• Study Start: December 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)