Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain

Not Applicable

Recruiting

• Conditions: Chronic Low-back Pain

• Registration Number: NCT06814470
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2024-07-16
• Status Verified: 2024-11
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retention	Through study intervention, an average of about four weeks	Proportion of subjects who complete all assessments from the total number of subjects enrolled
Satisfaction to the interventions	Through study interventions, an average of about four weeks	proportion of participants having therapy satisfaction scores above the midpoint
Safety of the intervention	Through study interventions, an average of about four weeks	Symptoms and adverse events reported by the participants

Secondary Outcome Measures

Name	Time	Method
PROMIS-29	baseline and after one month treatment	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.
Pain Bothersomeness scale	baseline and after one month treatment	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)	After each intervention.	MASS is a scale developed to measure sensations evoked by acupuncture treatment. The MASS will be applied after each treatment.
Vividness Scale	Through study interventions, an average of about four weeks	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).
Symptoms and Adverse Events	Through study interventions, an average of about four weeks	Symptoms and adverse events during or after treatment will be recorded after each treatment.

Trial Locations

Locations (1)

Lucy Chen; 🇺🇸 Charlestown, Massachusetts, United States