Low Back PainNCT02301741
Using an Interactive Game to Reduce Fear and Increase Spine Motion in Low Back Pain
A study testing Game in people with Low Back Pain, run by Ohio University at 1 site in United States.
Trial summary
A fundamental clinical problem in individuals with chronic low back pain is the significant alteration in movement patterns that restrict lumbar spine motion. This is particularly true for individuals with fear of re-injury with movement (i.e., kinesiophobia). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Answer Yes to the following:
- Have you had low back pain constantly or on most days for the last 3 months?
- Has your back pain caused you to seek medical care?
- Low back pain is classified from category 1 (back pain that does not radiate) through category 3 (back pain that radiates beyond the knee, but without neurological signs) on the Classification System of the Quebec Task Force on Spinal Disorders.
- Report elevated levels of kinesiophobia.
- Report no health conditions that may restrict movement or preclude safe participation.
Who cannot join
- Individuals must not:
- Have a personal history of the following neurological disorders: Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke
- Have a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
- Have a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis.
- Have a personal history of spine surgery or a hip arthroplasty
- Have active cancer or recent, unexplained weight loss
Show all 11Show fewer
- Report being blind
- Report being pregnant
- Report current or pending litigation related to back pain
- Currently be taking narcotic medication
- Score in the clinically significant range for substance abuse (Drug Abuse Screening Test (DAST) > 6), alcohol abuse (Alcohol Use Disorders Identification Test (AUDIT-C) > 4), or depression (Center for Epidemiological Studies-Depression (CES-D) > 16).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using an Interactive Game to Reduce Fear & Increase Spine Motion in Low Back Pain
A fundamental clinical problem in individuals with chronic low back pain is the significant alteration in movement patterns that restrict lumbar spine motion. This is particularly true for individuals with fear of re-injury with movement (i.e., kinesiophobia). The primary aims of the current study are to use a whole body video game environment to 1) determine the effects of game play on lumbar spine flexion and expectations of pain and harm and 2) determine the effects of altered movement gain on lumbar spine flexion.
Read the detailed description
Using a 2 groups (Game, Control) between subjects design, the investigators will assess the influence of participation in a computer game of virtual dodge ball that requires whole-body reaching movements to manipulate an on-screen avatar. Further, the investigators will gradually reduce the gain of lumbar spine motion of the participant's on-screen avatar across the three game sessions such that participants will need to produce progressively larger excursions of the lumbar spine to manipulate their avatar's spinal motion. Specifically, in game session 1, the spine motion of the avatar is equal to that of the participant (gain=1); in session 2 spine motion of the avatar is 5% less than the participant (gain=0.95); in session 3 spine motion of the avatar is 10% less than the participant (gain=0.90). The investigators will recruit participants with chronic low back pain and kinesiophobia. Participants in the GAME condition will complete laboratory sessions on five consecutive days. Session 1 (baseline) and Session 5 (post-test) will be used to assess lumbar spine motion and expectations of pain and harm during standardized reaching tasks. In sessions 2 through 4 they will play the virtual dodge ball game. Participants in the CONTROL condition will complete baseline and post-test standardized reaching tasks, but will not play the game in the intervening three days.
- Conditions
- Low Back Pain
- Being tested
- Game
- Keywords
- chronic low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GameBehavioural
We will assess the influence of participation in a computer game of virtual dodge ball that requires whole-body reaching movements to manipulate an on-screen avatar. We will gradually reduce the gain of lumbar spine motion of the participant's on-screen avatar across the three game sessions such that participants will need to produce progressively larger excursions of the lumbar spine to manipulate their avatar's spinal motion. Specifically, in game session 1, the spine motion of the avatar is equal to that of the participant (gain=1); in session 2 spine motion of the avatar is 5% less than the participant (gain=0.95); in session 3 spine motion of the avatar is 10% less than the participant (gain=0.90).
| Study group | Role | What they receive |
|---|---|---|
| Game Condition | Experimental | Participants in the GAME condition will complete laboratory sessions on five consecutive days. Session 1 (baseline) and Session 5 (post-test) will be used to assess lumbar spine motion and expectations of pain and harm during standardized reaching tasks. In sessions 2 through 4 they will play the virtual dodge ball game. Receives: Behavioral: Game |
| Control Condition | No intervention | Participants in the CONTROL condition will complete baseline and post-test standardized reaching tasks, but will not play the game in the intervening three days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine flexion changes
This assessment tracks the magnitude of spine motion used to complete standardized reaching tasks in which participants reach to 3 targets (High, Middle, Low) located in the mid-sagittal plane. Participants will perform five reaching trials to each the target location and then return to an upright posture, with rest provided between each trial. Lumbar spine flexion will be defined as the change in joint angle (i.e., the difference between the joint angles at the beginning of the trial before the go signal and those extracted 100 ms after target contact). The average of the five reaches to each target location will serve as the dependent variable.
Measured: baseline (day 1) to post-test (day 5)
Expectation of pain changes
For each target height, prior to the first reaching trial participants will be asked to rate the level of "expected pain" using a visual analog scale. The scale will consist of a 10-cm horizontal line with no numbers, marks, or descriptive vocabulary along its length. The scale will be anchored with the descriptors "No pain" and "Worst pain imaginable", respectively, at each end of the line. The pain expectancy ratings for each target location will serve as the dependent variable.
Measured: baseline (day 1) to post-test (day 5)
Expectation of harm changes
For each target height, prior to the first reaching trial participants will be asked to rate the level of "expected harm" using a visual analog scale. The scale will consist of a 10-cm horizontal line with no numbers, marks, or descriptive vocabulary along its length. The scale will be anchored with "Not at all concerned" and "Extremely concerned" regarding potential harm to the back during task performance. The harm expectancy ratings for each target location will serve as the dependent variable.
Measured: baseline (day 1) to post-test (day 5)
Secondary outcomes (1)
Lumbar spine flexion change as a function of altered movement gain
Change in lumbar flexion measured during game play will be measured across the three gaming sessions.
Measured: session day 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301741
- Sponsor's protocol ID
- R21AR064430-01A1
- Status last verified
- Jun 2016
- First submitted
- 24 Nov 2014
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thomas JS, France CR, Applegate ME, Leitkam ST, Walkowski S. Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial. J Pain. 2016 Dec;17(12):1302-1317. doi: 10.1016/j.jpain.2016.08.011. Epub 2016 Sep 9.
PubMed 27616607
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an Interactive Game to Reduce Fear & Increase Spine Motion in Low Back Pain
- ClinicalTrials.gov ID
- NCT02301741
- Acronym / sponsor ID
- R21AR064430-01A1
- Conditions
- Low Back Pain
- Keywords
- chronic low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A fundamental clinical problem in individuals with chronic low back pain is the significant alteration in movement patterns that restrict lumbar spine motion. This is particularly true for individuals with fear of re-injury with movement (i.e., kinesiophobia). The primary aims of the current study are to use a whole body video game environment to 1) determine the effects of game play on lumbar spine flexion and expectations of pain and harm and 2) determine the effects of altered movement gain on lumbar spine flexion.
Detailed description
Using a 2 groups (Game, Control) between subjects design, the investigators will assess the influence of participation in a computer game of virtual dodge ball that requires whole-body reaching movements to manipulate an on-screen avatar. Further, the investigators will gradually reduce the gain of lumbar spine motion of the participant's on-screen avatar across the three game sessions such that participants will need to produce progressively larger excursions of the lumbar spine to manipulate their avatar's spinal motion. Specifically, in game session 1, the spine motion of the avatar is equal to that of the participant (gain=1); in session 2 spine motion of the avatar is 5% less than the participant (gain=0.95); in session 3 spine motion of the avatar is 10% less than the participant (gain=0.90). The investigators will recruit participants with chronic low back pain and kinesiophobia. Participants in the GAME condition will complete laboratory sessions on five consecutive days. Session 1 (baseline) and Session 5 (post-test) will be used to assess lumbar spine motion and expectations of pain and harm during standardized reaching tasks. In sessions 2 through 4 they will play the virtual dodge ball game. Participants in the CONTROL condition will complete baseline and post-test standardized reaching tasks, but will not play the game in the intervening three days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game Condition | Experimental | Behavioral: GameParticipants in the GAME condition will complete laboratory sessions on five consecutive days. Session 1 (baseline) and Session 5 (post-test) will be used to assess lumbar spine motion and expectations of pain and harm during standardized reaching tasks. In sessions 2 through 4 they will play the virtual dodge ball game. |
| Control Condition | No intervention | –Participants in the CONTROL condition will complete baseline and post-test standardized reaching tasks, but will not play the game in the intervening three days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Answer Yes to the following:
- Low back pain is classified from category 1 (back pain that does not radiate) through category 3 (back pain that radiates beyond the knee, but without neurological signs) on the Classification System of the Quebec Task Force on Spinal Disorders.
- Report elevated levels of kinesiophobia.
- Report no health conditions that may restrict movement or preclude safe participation.
Key exclusion criteria (11 listed)
- Have a personal history of the following neurological disorders: Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke
- Have a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
- Have a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis.
- Have a personal history of spine surgery or a hip arthroplasty
- Have active cancer or recent, unexplained weight loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GameWe will assess the influence of participation in a computer game of virtual dodge ball that requires whole-body reaching movements to manipulate an on-screen avatar. We will gradually reduce the gain of lumbar spine motion of the participant's on-screen avatar across the three game sessions such that participants will need to produce progressively larger excursions of the lumbar spine to manipulate their avatar's spinal motion. Specifically, in game session 1, the spine motion of the avatar is equal to that of the participant (gain=1); in session 2 spine motion of the avatar is 5% less than the participant (gain=0.95); in session 3 spine motion of the avatar is 10% less than the participant (gain=0.90). | Behavioural | Game Condition |
Primary outcome
Lumbar spine flexion changes
Time frame: baseline (day 1) to post-test (day 5)
This assessment tracks the magnitude of spine motion used to complete standardized reaching tasks in which participants reach to 3 targets (High, Middle, Low) located in the mid-sagittal plane. Participants will perform five reaching trials to each the target location and then return to an upright posture, with rest provided between each trial. Lumbar spine flexion will be defined as the change in joint angle (i.e., the difference between the joint angles at the beginning of the trial before the go signal and those extracted 100 ms after target contact). The average of the five reaches to each target location will serve as the dependent variable.
Expectation of pain changes
Time frame: baseline (day 1) to post-test (day 5)
For each target height, prior to the first reaching trial participants will be asked to rate the level of "expected pain" using a visual analog scale. The scale will consist of a 10-cm horizontal line with no numbers, marks, or descriptive vocabulary along its length. The scale will be anchored with the descriptors "No pain" and "Worst pain imaginable", respectively, at each end of the line. The pain expectancy ratings for each target location will serve as the dependent variable.
Expectation of harm changes
Time frame: baseline (day 1) to post-test (day 5)
For each target height, prior to the first reaching trial participants will be asked to rate the level of "expected harm" using a visual analog scale. The scale will consist of a 10-cm horizontal line with no numbers, marks, or descriptive vocabulary along its length. The scale will be anchored with "Not at all concerned" and "Extremely concerned" regarding potential harm to the back during task performance. The harm expectancy ratings for each target location will serve as the dependent variable.
1 secondary outcome
Lumbar spine flexion change as a function of altered movement gain
Time frame: session day 2, 3 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Derived from this study: PubMed 27616607Thomas JS, France CR, Applegate ME, Leitkam ST, Walkowski S. Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial. J Pain. 2016 Dec;17(12):1302-1317. doi: 10.1016/j.jpain.2016.08.011. Epub 2016 Sep 9.
Related trials for Low Back Pain
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Ultrasound-guided Percutaneous Electrical Stimulation for Gluteus Muscle Dysfunction After Low Back Pain Episode
Low Back Pain, Functional Motor Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game in people with Low Back Pain, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar spine flexion changes (time frame: baseline (day 1) to post-test (day 5)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.