Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain

NCT ID: NCT06814470

Last Updated: 2026-01-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-16

Study Completion Date

2025-08-31

Brief Summary

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Testing the effect of Virtual Reality - guided imagery acupuncture

Detailed Description

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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.

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

subject will be randomized to 2 groups
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Virtual Reality - guided acupuncture imagery treatment (VRGAIT)

Group Type EXPERIMENTAL

Virtual reality guided imagery acupuncture treatment (VRGAIT)

Intervention Type OTHER

Subject watching Virtual reality video of acupuncture needle stimulation

Virtual Reality -guided acupuncture imagery treatment (VRGAIT) Control

Group Type ACTIVE_COMPARATOR

Virtual reality guided imagery acupuncture treatment control

Intervention Type OTHER

Subject watching VR video of swab touching

Interventions

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Virtual reality guided imagery acupuncture treatment (VRGAIT)

Subject watching Virtual reality video of acupuncture needle stimulation

Intervention Type OTHER

Virtual reality guided imagery acupuncture treatment control

Subject watching VR video of swab touching

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lucy Chen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lucy Chen

Charlestown, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018p002553-1

Identifier Type: -

Identifier Source: org_study_id

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