Clinical trial NCT02503410: An Interactive Gaming-based Intervention for Back Pain
Official title: Augmenting Back Pain Exercise Therapy Using an Interactive Gaming-based Intervention in the Home Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-specific Chronic Low Back Pain
Keywords: lower back
pain
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Pain Scale at 4 Weeks
timeFrame: Change from baseline in Visual Analogue Pain Scale score at 4 weeks
measure: Visual Analogue Pain Scale at 8 Weeks
timeFrame: Change from baseline in VAS score at 8 weeks
measure: Pain Frequency at 4 Weeks
timeFrame: Change in pain frequency at 4 weeks
measure: Pain Frequency at 8 Weeks
timeFrame: Change in pain frequency at 8 weeks
Secondary outcomes:
measure: Oswestry Low Back Pain Disability Questionnaire at 4 Weeks
timeFrame: Change in disability score at 4 weeks
measure: Oswestry Low Back Pain Disability Questionnaire at 8 Weeks
timeFrame: Change in disability score at 8 weeks
measure: SF36 at 4 Weeks
timeFrame: Change in clinical score at 4 weeks
measure: SF36 at 8 Weeks
timeFrame: Change in clinical score at 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital Boston
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: