Back to resultsAn Interactive Gaming-based Intervention for Back Pain
Primary Purpose
Non-specific Chronic Low Back Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual care
Interactive gaming
Sponsored by
About this trial
This is an interventional treatment trial for Non-specific Chronic Low Back Pain focused on measuring lower back, pain
Eligibility Criteria
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
Sites / Locations
- Spaulding Rehabilitation Hospital Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual care
Interactive gaming
Arm Description
Subjects receive physical therapy for low back pain as typically prescribed in the clinic.
Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.
Outcomes
Primary Outcome Measures
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).
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).
Pain Frequency at 4 Weeks
Subjects are asked how many days they experienced low back pain during the week prior to the study visit.
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
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.
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.
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.
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
Full Information
NCT ID
NCT02503410
First Posted
July 10, 2015
Last Updated
May 24, 2019
Sponsor
Spaulding Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02503410
Brief Title
An Interactive Gaming-based Intervention for Back Pain
Official Title
Augmenting Back Pain Exercise Therapy Using an Interactive Gaming-based Intervention in the Home Setting
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding to continue the study
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Chronic Low Back Pain
Keywords
lower back, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessor is blinded to treatment assignment.
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Subjects receive physical therapy for low back pain as typically prescribed in the clinic.
Arm Title
Interactive gaming
Arm Type
Experimental
Arm Description
Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interactive gaming
Intervention Description
Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system.
Primary Outcome Measure Information:
Title
Visual Analogue Pain Scale at 4 Weeks
Description
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
Title
Visual Analogue Pain Scale at 8 Weeks
Description
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
Title
Pain Frequency at 4 Weeks
Description
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
Title
Pain Frequency at 8 Weeks
Description
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
Secondary Outcome Measure Information:
Title
Oswestry Low Back Pain Disability Questionnaire at 4 Weeks
Description
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
Title
Oswestry Low Back Pain Disability Questionnaire at 8 Weeks
Description
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
Title
SF36 at 4 Weeks
Description
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
Title
SF36 at 8 Weeks
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Interactive Gaming-based Intervention for Back Pain
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