An Interactive Gaming-based Intervention for Back Pain

Mass General Brigham

Status

Terminated

Conditions

Non-specific Chronic Low Back Pain

Treatments

Behavioral: Usual care

Behavioral: Interactive gaming

Study type

Interventional

Funder types

Other

Identifiers

NCT02503410

2015-P-000663

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

English speaking
Back pain subject-rated > 3 on an 11 point visual-analog scale (0-10), with pain reported for a time > 6 months
Able to commit to all study visits
Low back pain attributable to mechanical etiology as opposed to infectious, neoplastic, or inflammatory causes.
BMI ≤ 40
Familiar with tablet use

Exclusion criteria

Vision or mobility impairment interfering with the performance of the interactive games
Current or anticipated receipt of payments from Worker's Compensation or other insurance for disability attributed to low back pain
Additional treatment for back pain during the period of the study, such as acupuncture
Unresolved musculoskeletal pathology of the lower limbs
Severe radiculopathic pain
Alcohol or substance abuse
Prior discectomy or implantation of rods, screws or plates (bulging disc without radicular pain is not exclusionary; hip or shoulder replacement is not exclusionary)
Current medication with coumadin or prednisone, chronic use of steroid medications, daily use of narcotic analgesics, or estrogen supplementation, tricyclic anti-depressants (if not on a regular steady dose at least one month prior to enrollment), or any substance that could impair balance.
Current diagnosis of:
1. Balance problems due to vestibular or other neurological impairments.
2. Osteoporosis (Osteopenia is not an exclusionary condition)
3. Fibromyalgia
4. Severe or progressive neurological deficits, including neuromotor impairment
5. Any hypercoagulation condition
6. Eczema, Psoriasis, or skin infections, and deep vein thrombosis
7. Burns or other acute trauma including unhealed bone fractures or open wounds
8. Psychiatric illness not well controlled, or current episode of exacerbated major depressive disorder
9. Rheumatoid arthritis
Any other major medical condition that would impair the subject's ability to complete the study visits
Any other major medical condition that has not been stabilized, or that would impair the subject's ability to complete the activities required by the study