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Testing the effect of Virtual Reality - guided imagery acupuncture
The aim of this study is to develop a Virtual Reality guided acupuncture imagery treatment system for the treatment of chronic low back pain. This product will provide a new cost-effective treatment option for chronic low back pain and potentially other chronic pain disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality - guided acupuncture imagery treatment (VRGAIT) | Experimental |
| |
| Virtual Reality -guided acupuncture imagery treatment (VRGAIT) Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality guided imagery acupuncture treatment (VRGAIT) | Other | Subject watching Virtual reality video of acupuncture needle stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Proportion of subjects who complete all assessments from the total number of subjects who were enrolled in the study | Through study intervention, an average of about four weeks |
| Satisfaction to the Interventions | Mean of the satisfaction score on a scale from 1 to 5, larger number indicated greater satisfaction. Assessed after each study interventions, an average score is reported., | up to 4 weeks |
| Number of Adverse Events (Safety of the Intervention) | Symptoms and adverse events reported by the participants | Through study interventions, an average of about four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS-29 | The PROMIS-29 profile measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain. We use pain intensity in this report, low score indicates improvement. | baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucy Chen | Charlestown | Massachusetts | 02129 | United States |
The Small Business Act permits NIH SBIR/STTR grantees to withhold data for 4 years after the end of the grant award.
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT) | Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation |
| FG001 | Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control | Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Individuals with chronic low back pain
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT) | Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation |
| BG001 | Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control |
| 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 | Retention | Proportion of subjects who complete all assessments from the total number of subjects who were enrolled in the study | Posted | Count of Participants | Participants | Through study intervention, an average of about four weeks |
|
1 months
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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 | Virtual Reality - Guided Acupuncture Imagery Treatment (VRGAIT) | Virtual reality guided imagery acupuncture treatment (VRGAIT): Subject watching Virtual reality video of acupuncture needle stimulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lucy Chen | MGH | 6177243466 | llchen@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2024 | Nov 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2024 | Nov 21, 2025 | SAP_001.pdf |
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subject will be randomized to 2 groups
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| Virtual reality guided imagery acupuncture treatment control | Other | Subject watching VR video of swab touching |
|
| Pain Bothersomeness Scale | This is a self-reported measure of cLBP pain severity that is commonly used to assess clinical chronic pain. Participants rate how bothersome their LBP was during the previous week with a VAS scale (0-10) from "not at all bothersome" (0) to "extremely bothersome" (10). | baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported. |
| MGH Acupuncture Sensation Scale (MASS) | MASS is a scale developed to measure sensations evoked by acupuncture treatment (total range 0-120). The MASS will be applied after each treatment. We reported total score in this report (average of sum of each session). larger numbers indicate stronger sensations. | up to 4 weeks. |
| Vividness Scale | Vividness Scale is a 0-10 vividness scale to measure imagery vividness during the intervention. The scale ranges from Not Vivid/Unclear (0) to Vivid/Clear (10). | After each study interventions, the average score is reported. |
Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
|
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| Primary | Satisfaction to the Interventions | Mean of the satisfaction score on a scale from 1 to 5, larger number indicated greater satisfaction. Assessed after each study interventions, an average score is reported., | Posted | Mean | Standard Deviation | scores on a scale | up to 4 weeks |
|
|
|
| Primary | Number of Adverse Events (Safety of the Intervention) | Symptoms and adverse events reported by the participants | Posted | Number | number of adverse event | Through study interventions, an average of about four weeks |
|
|
|
| Secondary | PROMIS-29 | The PROMIS-29 profile measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain. We use pain intensity in this report, low score indicates improvement. | Posted | Mean | 95% Confidence Interval | scores on a scale | baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported. |
|
|
|
| Secondary | Pain Bothersomeness Scale | This is a self-reported measure of cLBP pain severity that is commonly used to assess clinical chronic pain. Participants rate how bothersome their LBP was during the previous week with a VAS scale (0-10) from "not at all bothersome" (0) to "extremely bothersome" (10). | pre minus post intervention score is reported | Posted | Mean | 95% Confidence Interval | scores on a scale | baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported. |
|
|
|
| Secondary | MGH Acupuncture Sensation Scale (MASS) | MASS is a scale developed to measure sensations evoked by acupuncture treatment (total range 0-120). The MASS will be applied after each treatment. We reported total score in this report (average of sum of each session). larger numbers indicate stronger sensations. | Posted | Mean | Standard Deviation | unit on a scale | up to 4 weeks. |
|
|
|
| Secondary | Vividness Scale | Vividness Scale is a 0-10 vividness scale to measure imagery vividness during the intervention. The scale ranges from Not Vivid/Unclear (0) to Vivid/Clear (10). | Posted | Mean | Standard Deviation | the unit on the scale | After each study interventions, the average score is reported. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Virtual Reality -Guided Acupuncture Imagery Treatment (VRGAIT) Control | Virtual reality guided imagery acupuncture treatment control: Subject watching VR video of swab touching | 0 | 16 | 0 | 16 | 0 | 16 |
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