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OpenTrials
Completed

NCT Number: NCT06814470

Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain

Testing the effect of Virtual Reality - guided imagery acupuncture

Completed

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Key information

Conditions

Chronic Low-back Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucy Chen

Charlestown, Massachusetts, 02129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality guided imagery acupuncture treatment (VRGAIT)

Other

Subject watching Virtual reality video of acupuncture needle stimulation

Virtual reality guided imagery acupuncture treatment control

Other

Subject watching VR video of swab touching

Primary outcomes

  1. Retention

    Time frame: 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

  2. Satisfaction to the Interventions

    Time frame: 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.,

  3. Number of Adverse Events (Safety of the Intervention)

    Time frame: Through study interventions, an average of about four weeks

    Symptoms and adverse events reported by the participants

Secondary outcomes

  1. PROMIS-29

    Time frame: 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.

  2. Pain Bothersomeness Scale

    Time frame: 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).

  3. MGH Acupuncture Sensation Scale (MASS)

    Time frame: 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.

  4. Vividness Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

A Feasibility Study of Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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