The Kaia Back Pain Intervention for Self-management of Low Back Pain
NCT ID: NCT04290078
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
184 participants
INTERVENTIONAL
2020-12-01
2021-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Kaia Back Pain Study Intervention
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.
Kaia Back Pain Study App
Kaia Back Pain is an integrated solution for self-management of low-back pain that digitizes multidisciplinary rehabilitation into a smartphone application.
Control Group
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.
Usual Care
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Kaia Back Pain Study App
Kaia Back Pain is an integrated solution for self-management of low-back pain that digitizes multidisciplinary rehabilitation into a smartphone application.
Usual Care
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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)
21 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brigham and Women's Hospital
OTHER
Kaia Health Software
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Assoc. Prof. Srdjan Nedeljkovic, MD
Role: PRINCIPAL_INVESTIGATOR
Physiatry, Spine & Pain Management
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brigham and Women's Hospital /Physiatry, Spine & Pain Management
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KaiaBP001
Identifier Type: -
Identifier Source: org_study_id