Chronic Low Back Pain, Fear of Injury, Fear of Pain
Conditions
Brief summary
This study will measure the effects of interactive, whole-body video games on movement behavior in people with chronic low back pain.
Detailed description
A fundamental clinical problem in individuals with chronic low back pain is the significant alteration in movement patterns that restrict lumbar spine motion. This restriction of lumbar motion is particularly evident in patients with kinesiophobia; that is, a fear of movement due to possible injury or reinjury. For chronic back pain patients with kinesiophobia it is critical to develop an effective intervention to increase spine motion while minimizing concerns of pain and harm. Accordingly, we have developed a innovative video games that track whole-body motion and are designed to encourage spinal flexion while reducing concerns of pain and harm among individuals with low back pain. Our games have two distinct advantages. First, within this video game environment, visual feedback can be altered by changing the feedback gain of a given movement (e.g., the magnitude of a given joint movement could appear on screen as either larger or smaller than the actual movement). Thus, gain manipulation will result in progressively larger amounts of lumbar spine flexion during game play. Second, video games are potent distractors that can reduce attention to pain.
Interventions
BEHAVIORALExperimental Group 1
Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).
BEHAVIORALExperimental Group 2
Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).
Sponsors
Ohio University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The principal investigators, the statistician, and members of the data collection team will remain blinded to intervention assignment throughout the duration of the study. They will be given the identifying codes only at the end of the study when it is necessary to interpret the results. The un-blinded study coordinator, who is responsible for scheduling testing and treatment sessions, will serve to receive the study patients and escort them to the various testing and treatments sites to minimize the interaction between patients; however, the study coordinator will not participate in the assessments.
Intervention model description
Participants will be randomly assigned to one of two intervention arms. Both intervention arms involve immersive video games that encourage participants to produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. The two groups are distinguished by the amount of lumbar flexion needed to achieve game objectives. One is a control group and the other is the experimental.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 18-60 years of age * Low back pain that has been ongoing for at least half the days in the last 6 months * Average pain intensity of greater than 3 over the past week on a 0-10 Numerical Rating Scale * Disability greater than 4 on Roland and Morris Disability Questionnaire * Agrees with statement It is not really safe for a person with my back problem to be physically active or Tampa Scale of Kinesiophobia score greater than 36 * Has sought care or consultation from a health care provider for back pain * Meets category 1, 2, or 3 on the Classification System of the Quebec Task Force on Spinal Disorders which reflects low back pain without neurological signs * Working proficiency in English
Exclusion criteria
* Has a personal history of the following neurological disorders: Alzheimers, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinsons, Neuropathy, Stroke, Seizures * Has a personal history of the following cardiorespiratory disorders: Congestive heart failure, heart attack in past 2 years * Has a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, Muscular Dystrophy, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis * History of spine surgery or a hip arthroplasty * Has active cancer * Has a chronic disease that may restrict movement or preclude safe participation * Has used opioids within 30 days prior to study enrollment * Reports being pregnant, lactating, or that they anticipate becoming pregnant within 2-months * Reports pending litigation related to CLBP * Has current drug or alcohol use or dependence that, in the opinion of the PIs, would interfere with adherence to study requirements * Has significant visual impairment that would prevent virtual reality headset use * Has significant motion sickness that would prevent virtual reality headset use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS) | Baseline measure through the 48-weeks post-treatment measure | The Numerical Pain Rating Scale (NPRS) is a pain assessment tool that uses a 11 point scale of 0-10 to help patients rate the intensity of their pain: 0: No pain and 10: The worst pain imaginable. The NPRS is the most commonly used unidimensional pain scale. It can be administered verbally or graphically, and patients are asked to select the number that best reflects their pain intensity over the past 24 hours. The smaller the number (closer to 0), the less pain the subject is enduring, and the larger the number, the more pain they are enduring. Percent change in NPRS rather than raw score change may provide more meaningful information regarding a patient's response to pain treatment. |
| Change in Disability Using the Roland Morris Disability Questionnaire | Baseline measurement through 48-weeks post-treatment measurement change | Roland Morris Disability Questionnaire: A patient taking the survey agrees or disagrees with these statements (Yes/No). The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability. The sum of the seven items equals the total score of the PDI, which ranges from 0 to 70, with higher scores (closer to 70) reflecting higher interference of pain with daily activities and a lower score (closer to 0) has less interference of pain with daily activities.. Test-retest reliability 24-item: intraclass correlation (ICC) ranges from 0.42 - 0.91 T |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group 1 Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.
Experimental Group 1: Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9). | 74 |
| Experimental Group 2 Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.
Experimental Group 2: Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9). | 80 |
| Total | 154 |
Baseline characteristics
| Characteristic | Experimental Group 2 | Total | Experimental Group 1 |
|---|---|---|---|
| Age, Customized | 41.1 years | 39.05 years | 37 years |
| Median BMI | 26.7 kg/m^2 | 28.3 kg/m^2 | 29.9 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 26 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 49 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 70 Participants | 35 Participants |
| Radiating pain no | 29 Participants | 51 Participants | 22 Participants |
| Radiating pain yes | 51 Participants | 103 Participants | 52 Participants |
| Region of Enrollment United States | 80 participants | 154 participants | 74 participants |
| Sex: Female, Male Female | 50 Participants | 100 Participants | 50 Participants |
| Sex: Female, Male Male | 30 Participants | 54 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 80 |
| other Total, other adverse events | 4 / 74 | 3 / 80 |
| serious Total, serious adverse events | 0 / 74 | 0 / 80 |
Outcome results
Primary
Change in Disability Using the Roland Morris Disability Questionnaire
Roland Morris Disability Questionnaire: A patient taking the survey agrees or disagrees with these statements (Yes/No). The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability. The sum of the seven items equals the total score of the PDI, which ranges from 0 to 70, with higher scores (closer to 70) reflecting higher interference of pain with daily activities and a lower score (closer to 0) has less interference of pain with daily activities.. Test-retest reliability 24-item: intraclass correlation (ICC) ranges from 0.42 - 0.91 T
Time frame: Baseline measurement through 48-weeks post-treatment measurement change
Population: Subjects that completed this procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group 1 | Change in Disability Using the Roland Morris Disability Questionnaire | 37 score on Roland Morris Disability Questi | Standard Deviation 34.6 |
| Experimental Group 2 | Change in Disability Using the Roland Morris Disability Questionnaire | 25 score on Roland Morris Disability Questi | Standard Deviation 35.2 |
Primary
Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS)
The Numerical Pain Rating Scale (NPRS) is a pain assessment tool that uses a 11 point scale of 0-10 to help patients rate the intensity of their pain: 0: No pain and 10: The worst pain imaginable. The NPRS is the most commonly used unidimensional pain scale. It can be administered verbally or graphically, and patients are asked to select the number that best reflects their pain intensity over the past 24 hours. The smaller the number (closer to 0), the less pain the subject is enduring, and the larger the number, the more pain they are enduring. Percent change in NPRS rather than raw score change may provide more meaningful information regarding a patient's response to pain treatment.
Time frame: Baseline measure through the 48-weeks post-treatment measure
Population: Study participants who completed this procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group 1 | Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS) | 30.3 percentage change (NPRS) | Standard Deviation 43.2 |
| Experimental Group 2 | Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS) | 35.2 percentage change (NPRS) | Standard Deviation 33 |