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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
7
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.
Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system.
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, United States
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Change in pain frequency at 8 weeks
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Change in clinical score at 8 weeks