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

Low Back Pain Clinical Trial

Official title:
The Kaia Back Pain Intervention for Self-management of Low Back Pain - a Randomized Controlled Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04290078
Study type Interventional
Source Kaia Health Software
Contact
Status Enrolling by invitation
Phase N/A
Start date December 1, 2020
Completion date August 1, 2021
View Details
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