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Lack of funding to continue the study
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Subjects receive physical therapy for low back pain as typically prescribed in the clinic. |
|
| Interactive gaming | Experimental | Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital Boston | Boston | Massachusetts | 02129 | United States |
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Subjects were recruited primarily among the outpatient population of individuals with low back pain at Spaulding Rehabilitation Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Subjects receive physical therapy for low back pain as typically prescribed in the clinic. |
| FG001 | Interactive Gaming | Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Subjects receive physical therapy for low back pain as typically prescribed in the clinic. |
| BG001 | Interactive Gaming | Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Change from baseline in Visual Analogue Pain Scale score at 4 weeks |
|
We collected information in regard to potential adverse events during the 8 weeks of the study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Subjects receive physical therapy for low back pain as typically prescribed in the clinic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paolo Bonato | Spaulding Rehabilitation Hospital | 617-952-6319 | pbonato@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2016 | May 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Assessor is blinded to treatment assignment.
| Interactive gaming | Behavioral | Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system. |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Visual Analog Pain Scale | 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). | Mean | Standard Deviation | units on a scale |
|
| Pain Frequency | Subjects are asked how many days they experienced low back pain during the week prior to the study visit. | Mean | Standard Deviation | days |
|
| OG001 | Interactive Home-Based System Group | physical therapy (as prescribed during 8 to 12 weeks) and interactive exercises program at home with the Valedo® System (Hocoma AG) (at least 2x/week) Interactive gaming home-based exercises: Subjects will receive a combination of physical therapy (during 8 to 12 weeks) and at least two sessions of interactive exercises program at home with the Valedo® System (Hocoma AG). Subjects will fill out a questionnaire about their pain every two weeks during the treatment period. Valedo® System (Hocoma AG) |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Change from baseline in VAS score at 8 weeks |
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| 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. | Posted | Mean | Standard Deviation | days | Change in pain frequency at 4 weeks |
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| 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. | Posted | Mean | Standard Deviation | days | Change in pain frequency at 8 weeks |
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| 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. | Posted | Mean | Standard Deviation | percentage disability | Change in disability score at 4 weeks |
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| 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. | Posted | Mean | Standard Deviation | percentage disability | Change in disability score at 8 weeks |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Change in clinical score at 4 weeks |
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| 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 | Posted | Mean | Standard Deviation | units on a scale | Change in clinical score at 8 weeks |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Interactive Gaming | Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system. | 0 | 3 | 0 | 3 | 0 | 3 |
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