Expired Study
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Boston, Massachusetts 02129


Purpose:

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.


Criteria:

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


NCT ID:

NCT02503410


Primary Contact:

Principal Investigator
Paolo Bonato, PhD
Spaulding Rehabilitation Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02129
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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