An Interactive Gaming-based Intervention for Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Non-specific Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Usual care
* Behavioral: Interactive gaming


Participation Criteria
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Eligibility Criteria
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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: Balance problems due to vestibular or other neurological impairments. Osteoporosis (Osteopenia is not an exclusionary condition) Fibromyalgia Severe or progressive neurological deficits, including neuromotor impairment Any hypercoagulation condition Eczema, Psoriasis, or skin infections, and deep vein thrombosis Burns or other acute trauma including unhealed bone fractures or open wounds Psychiatric illness not well controlled, or current episode of exacerbated major depressive disorder 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Subjects receive physical therapy for low back pain as typically prescribed in the clinic. | Behavioral: Usual care<br>* 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.<br>|
| Experimental: Interactive gaming<br>Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system. | Behavioral: Interactive gaming<br>* Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Scale at 4 Weeks | Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain). | Change from baseline in Visual Analogue Pain Scale score at 4 weeks | 
| Visual Analogue Pain Scale at 8 Weeks | Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain). | Change from baseline in VAS score at 8 weeks | 
| Pain Frequency at 4 Weeks | Subjects are asked how many days they experienced low back pain during the week prior to the study visit. | Change in pain frequency at 4 weeks | 
| Pain Frequency at 8 Weeks | Subjects are asked how many days they experienced low back pain during the week prior to the study visit. | Change in pain frequency at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Low Back Pain Disability Questionnaire at 4 Weeks | Subjects are asked to fill in a questionnaire inquiring about how their pain interferes with their activities of daily living. Accordingly, they receive a disability score ranging between 0 and 100%. A score between 0 and 20% indicates minimal disability; a score between 21 and 40% indicates moderate disability; a score between 41 and 60% indicates severe disability; a score between 61 and 80% indicates that pain impinges on all aspects of the patient's life; and score between 81 and 100% indicates that the subject is bed-bound. | Change in disability score at 4 weeks | 
| Oswestry Low Back Pain Disability Questionnaire at 8 Weeks | Subjects are asked to fill in a questionnaire inquiring about how their pain interferes with their activities of daily living. Accordingly, they receive a disability score ranging between 0 and 100%. A score between 0 and 20% indicates minimal disability; a score between 21 and 40% indicates moderate disability; a score between 41 and 60% indicates severe disability; a score between 61 and 80% indicates that pain impinges on all aspects of the patient's life; and score between 81 and 100% indicates that the subject is bed-bound. | Change in disability score at 8 weeks | 
| SF36 at 4 Weeks | The SF36 is a clinical outcome measure based on the administration of a questionnaire inquiring about the quality of life and health status of the subject. It consists of eight normalized (so that they have the some weight) scores related to vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The lower the score the more disability. The higher the score the less disability. The score is provide as units on a scale from 0 to 100. | Change in clinical score at 4 weeks | 
| SF36 at 8 Weeks | The SF36 is a clinical outcome measure based on the administration of a questionnaire inquiring about the quality of life and health status of the subject. It consists of eight normalized (so that they have the some weight) scores related to vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The lower the score the more disability. The higher the score the less disability. The score is provide as units on a scale from 0 to 100 | Change in clinical score at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lower back, pain