Chronic Low-back Pain
Conditions
Brief summary
Testing the effect of Virtual Reality - guided imagery acupuncture
Detailed description
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.
Interventions
OTHERVirtual reality guided imagery acupuncture treatment (VRGAIT)
Subject watching Virtual reality video of acupuncture needle stimulation
OTHERVirtual reality guided imagery acupuncture treatment control
Subject watching VR video of swab touching
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
subject will be randomized to 2 groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Volunteers 18-75 years of age. * Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician. * At least 4/10 clinical pain on the 11-point LBP intensity scale. * Must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. Documentation of this evaluation will be sought from Partners or outside medical records and kept in the subject's research record. * At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
Exclusion criteria
* Specific causes of back pain (e.g. cancer, fractures, infections), * Complicated back problems (e.g. prior back surgery, medico legal issues), * Possible contraindications for acupuncture (e.g. coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis). * Conditions making study participation difficult (eg, paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1) * The intent to undergo surgery during the time of involvement in the study. * Unresolved medical legal/disability/workers compensation claims in connection with low back pain. * Lacking the capacity to consent for oneself * Do not have access to zoom or other software regularly to complete the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | Through study intervention, an average of about four weeks | Proportion of subjects who complete all assessments from the total number of subjects who were enrolled in the study |
| Satisfaction to the Interventions | up to 4 weeks | 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., |
| Number of Adverse Events (Safety of the Intervention) | Through study interventions, an average of about four weeks | Symptoms and adverse events reported by the participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-29 | baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported. | 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. |
| Pain Bothersomeness Scale | baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported. | 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). |
| MGH Acupuncture Sensation Scale (MASS) | up to 4 weeks. | 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. |
| Vividness Scale | After each study interventions, the average score is reported. | 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). |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50 year STANDARD_DEVIATION 17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 0 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
None listed