Non-specific Chronic Low Back Pain
Conditions
Keywords
lower back, pain
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.
Interventions
BEHAVIORALUsual care
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.
BEHAVIORALInteractive gaming
Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessor is blinded to treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited primarily among the outpatient population of individuals with low back pain at Spaulding Rehabilitation Hospital.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Subjects receive physical therapy for low back pain as typically prescribed in the clinic. | 4 |
| Interactive Gaming Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system. | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Usual Care | Interactive Gaming | Total |
|---|---|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 10.4 | 31.7 years STANDARD_DEVIATION 3.8 | 34.6 years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pain Frequency | 5.3 days STANDARD_DEVIATION 0.9 | 6.0 days STANDARD_DEVIATION 1.7 | 5.8 days STANDARD_DEVIATION 1.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
| Visual Analog Pain Scale | 3.5 units on a scale STANDARD_DEVIATION 1.3 | 4.0 units on a scale STANDARD_DEVIATION 1 | 3.7 units on a scale STANDARD_DEVIATION 1.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Pain Frequency at 4 Weeks | 2.5 days | Standard Deviation 2.4 |
| Interactive Home-Based System Group | Pain Frequency at 4 Weeks | -0.3 days | Standard Deviation 0.6 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Pain Frequency at 8 Weeks | -0.2 days | Standard Deviation 2.1 |
| Interactive Home-Based System Group | Pain Frequency at 8 Weeks | 0.0 days | Standard Deviation 0 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Visual Analogue Pain Scale at 4 Weeks | 0.0 units on a scale | Standard Deviation 0.8 |
| Interactive Home-Based System Group | Visual Analogue Pain Scale at 4 Weeks | 0.3 units on a scale | Standard Deviation 1.2 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Visual Analogue Pain Scale at 8 Weeks | 0.2 units on a scale | Standard Deviation 1.7 |
| Interactive Home-Based System Group | Visual Analogue Pain Scale at 8 Weeks | 1.3 units on a scale | Standard Deviation 1.2 |
Secondary
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.
Time frame: Change in disability score at 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Oswestry Low Back Pain Disability Questionnaire at 4 Weeks | 1.0 percentage disability | Standard Deviation 3.5 |
| Interactive Home-Based System Group | Oswestry Low Back Pain Disability Questionnaire at 4 Weeks | 4.7 percentage disability | Standard Deviation 4.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Oswestry Low Back Pain Disability Questionnaire at 8 Weeks | 12.7 percentage disability | Standard Deviation 10.6 |
| Interactive Home-Based System Group | Oswestry Low Back Pain Disability Questionnaire at 8 Weeks | 11.3 percentage disability | Standard Deviation 7 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | SF36 at 4 Weeks | 2.6 units on a scale | Standard Deviation 14.6 |
| Interactive Home-Based System Group | SF36 at 4 Weeks | 6.6 units on a scale | Standard Deviation 11.2 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | SF36 at 8 Weeks | 13.2 units on a scale | Standard Deviation 6.1 |
| Interactive Home-Based System Group | SF36 at 8 Weeks | 9.5 units on a scale | Standard Deviation 15.7 |