An Interactive Gaming-based Intervention for Back Pain

Non-specific Chronic Low Back Pain Clinical Trial

Official title: Augmenting Back Pain Exercise Therapy Using an Interactive Gaming-based Intervention in the Home Setting

Status Terminated

Clinical Trial Summary

This study aims to compare the outcomes of a traditional, exercise-based rehabilitation intervention for chronic low back pain with the outcomes achieved by combining a traditional intervention with adjunct therapy delivered using an interactive gaming-based system for home-based therapy.

Clinical Trial Description

The study relies upon the Valedo system by Hocoma AG to implement an interactive gaming-based intervention (i.e. subjects receive part of their physical therapy by playing interactive video games). The system is similar to consumer electronics products for interactive gaming that track the subject's movements using body-worn sensors. The FDA has determined that the Valedo system is a 510(K) exempt device under the product code ION (i.e. exerciser, non-measuring device for Physical Medicine). In the study, subjects with non-specific chronic low back pain are randomized using a block design to one of two groups: group 1 receives usual care alone; group 2 receives an exercise-based rehabilitation intervention using interactive gaming in addition to usual care. Clinical assessments are performed at baseline and again 4 weeks and 8 weeks after baseline measures are gathered. ;

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-specific Chronic Low Back Pain

• NCT number: NCT02503410
• Study type: Interventional
• Source: Spaulding Rehabilitation Hospital
• Status: Terminated
• Phase: N/A
• Start date: September 2015
• Completion date: June 2017