Clinical trial NCT06814470: Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain
Official title: A Feasibility Study of Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: subject will be randomized to 2 groups
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retention
timeFrame: Through study intervention, an average of about four weeks
measure: Satisfaction to the interventions
timeFrame: Through study interventions, an average of about four weeks
measure: Safety of the intervention
timeFrame: Through study interventions, an average of about four weeks
Secondary outcomes:
measure: PROMIS-29
timeFrame: baseline and after one month treatment
measure: Pain Bothersomeness scale
timeFrame: baseline and after one month treatment
measure: MGH Acupuncture Sensation Scale (MASS)
timeFrame: After each intervention.
measure: Vividness Scale
timeFrame: Through study interventions, an average of about four weeks
measure: Symptoms and Adverse Events
timeFrame: Through study interventions, an average of about four weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Lucy Chen
state: Massachusetts
Study officials:
References: