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



Status:Terminated
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 65
Updated:12/13/2017
Start Date:August 2015
End Date:March 2017

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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. 50 subjects with non-specific cLBP will be recruited in the study.
Following baseline measures, study volunteers will be randomized to either the Usual Care
alone group or to the Interactive Home-Based System group. In each group, an endpoint
assessment session will be conducted at approximately 4 and 8 weeks post baseline measures.


Inclusion Criteria:

- English speaking and reading

- Back pain subject-rated at > 3 on an 11 point VAS scale (0-10), with a duration > six
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:

- Impairment in vision or mobility interfere with required participation in the study

- Current or anticipated receipt of payments from Worker's Compensation or other
insurance for disability attributed to low back pain.

- Plans to initiate 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 (Osteopina is not an exclusionary condition)

3. Fibromyaligia

4. Severe or progressive neurological deficits, including neuromotor impairment

5. Any hypercoagulation condition

6. Eczema, Psoriasis, or skin infectionsdeep 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
We found this trial at
1
site
Boston, Massachusetts 02114
Principal Investigator: Paolo Bonato, PhD
Phone: 617-952-6321
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mi
from
Boston, MA
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