An Interactive Gaming-based Intervention for Back Pain

NCT ID: NCT02503410

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-06-30

Brief 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.

Detailed 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.

Conditions

Non-specific Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care

Subjects receive physical therapy for low back pain as typically prescribed in the clinic.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Subjects receive standard physical therapy, including outpatient visits as prescribed by the treating clinician and home-based exercises based on recommendations by the physical therapist.

Interactive gaming

Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.

Group Type: EXPERIMENTAL

Interactive gaming

Intervention Type: BEHAVIORAL

Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system.

Interventions

Usual care

Subjects receive standard physical therapy, including outpatient visits as prescribed by the treating clinician and home-based exercises based on recommendations by the physical therapist.

Intervention Type: BEHAVIORAL

Interactive gaming

Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paolo Bonato

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Bonato, PhD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-P-000663

Identifier Type: -

Identifier Source: org_study_id