Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain

NCT06814470 | Completed Results DMC

• 1 other identifier: 2018p002553-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Testing the effect of Virtual Reality - guided imagery acupuncture

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• PROMIS-29

  baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported.

• Pain Bothersomeness Scale

  baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported.

• MGH Acupuncture Sensation Scale (MASS)

  up to 4 weeks.

• Vividness Scale

  After each study interventions, the average score is reported.

Study Arms (2)

Virtual Reality - guided acupuncture imagery treatment (VRGAIT)

EXPERIMENTAL

Other: Virtual reality guided imagery acupuncture treatment (VRGAIT)

Virtual Reality -guided acupuncture imagery treatment (VRGAIT) Control

ACTIVE COMPARATOR

Other: Virtual reality guided imagery acupuncture treatment control

Interventions

Virtual reality guided imagery acupuncture treatment (VRGAIT) OTHER

Subject watching Virtual reality video of acupuncture needle stimulation

Virtual Reality - guided acupuncture imagery treatment (VRGAIT)

Virtual reality guided imagery acupuncture treatment control OTHER

Subject watching VR video of swab touching

Virtual Reality -guided acupuncture imagery treatment (VRGAIT) Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Lucy Chen

Charlestown, Massachusetts, 02129, United States

Location

Results Point of Contact

• Title: Lucy Chen
• Organization: MGH

llchen@mgh.harvard.edu

6177243466

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: subject will be randomized to 2 groups

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 7, 2025
• Study Start: July 16, 2024
• Primary Completion: January 3, 2025
• Study Completion: August 31, 2025
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)