An Interactive Gaming-based Intervention for Back Pain

Not Applicable

Terminated

Conditions: Non-specific Chronic Low Back Pain

Interventions: Behavioral: Usual care
Behavioral: Interactive gaming

Registration Number: NCT02503410

Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 7

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Subjects receive physical therapy for low back pain as typically prescribed in the clinic.
Interactive gaming	Interactive gaming	Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.

Primary Outcome Measures

Name	Time	Method
Pain Frequency at 4 Weeks	Change in pain frequency at 4 weeks	Subjects are asked how many days they experienced low back pain during the week prior to the study visit.
Visual Analogue Pain Scale at 4 Weeks	Change from baseline in Visual Analogue Pain Scale score 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).
Visual Analogue Pain Scale at 8 Weeks	Change from baseline in VAS score 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).
Pain Frequency at 8 Weeks	Change in pain frequency at 8 weeks	Subjects are asked how many days they experienced low back pain during the week prior to the study visit.

Secondary Outcome Measures

Name	Time	Method
Oswestry Low Back Pain Disability Questionnaire at 4 Weeks	Change in disability score 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.
Oswestry Low Back Pain Disability Questionnaire at 8 Weeks	Change in disability score 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.
SF36 at 4 Weeks	Change in clinical score 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.
SF36 at 8 Weeks	Change in clinical score 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