Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back Pain

NCT03765879 | Active Not Recruiting DMC

• 1 other identifier: 2018P002553
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will examine the analgesic effects of acupuncture imagery treatment in patients with chronic low back pain. The intervention used in this study is "video-guided acupuncture imagery treatment" (VGAIT) treatment. The control used in this study is sham (fake) VGAIT. Participants in each group will participate in 8 study sessions (including 6 treatment sessions) over the course of 6 weeks. The primary outcome measure for this study is change in low back pain severity score after each treatment session.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Changes in low back pain (LBP) severity score

  LBP Severity will be measured by a single-item questionnaire that asks participants to rate how bothersome their back pain has been during the past week on a visual analog scale.

  6 weeks

Secondary Outcomes (6)

• Changes in back-pain specific disability score

  6 weeks

• Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System-29 (PROMIS-29) score

  6 weeks

• Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System (PROMIS) Global Health score

  6 weeks

• Changes in psychiatric symptoms as measured by PROMIS-29

  6 weeks

• Changes in psychiatric symptoms as measured by PROMIS Global Health

  6 weeks

Study Arms (2)

Verum VGAIT Group

EXPERIMENTAL

Participants in this group will receive verum (real) acupuncture and verum video-guided acupuncture imagery treatment (VGAIT).

Other: Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)

Sham VGAIT Group

PLACEBO COMPARATOR

Participants in this group will receive sham acupuncture and sham VGAIT.

Other: Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)

Interventions

Verum VGAIT (Video-Guided Acupuncture Imagery Treatment) OTHER

In VGAIT treatment sessions, participants will re-watch the video of an avatar receiving acupuncture treatment, and they will be asked to vividly imagine that the treatment is being concurrently applied on themself.

Verum VGAIT Group

Sham VGAIT (Video-Guided Acupuncture Imagery Treatment) OTHER

In sham VGAIT treatment sessions, participants will re-watch this video of an avatar receiving the sham acupuncture treatment, and they will be asked to vividly imagine that the treatment is being concurrently applied on themself.

Sham VGAIT Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers 18-60 years of age
• Meet the Classification Criteria of the chronic low back pain (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 low back pain 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.
• History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia.
• Unresolved medical legal/disability/workers compensation claims in connection with low back pain.
• Active substance abuse disorder in the past 24 months, as determined by self-report and/or urine toxicology
• Lacking the capacity to consent for oneself

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (1)

• Hodges S, Li Y, Wu J, Ma L, Liu Y, Reddy S, Sacca V, Walker KM, Chen L, Camprodon JA, Orr SP, Fregni F, Zhang Y, Yao S, Vangel M, Kong J. Novel avatar-based video-guided acupuncture imagery treatment for chronic low back pain: a randomised controlled trial in the USA. EClinicalMedicine. 2025 Oct 10;89:103538. doi: 10.1016/j.eclinm.2025.103538. eCollection 2025 Nov.

  PMID: 41140457 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This experiment will not be blinded. Participants will be aware if they are in the verum VGAIT or sham VGAIT group by nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: In this study, participants will be randomly assigned to receive one of two interventions: verum video-guided acupuncture imagery treatment (VGAIT) or sham VGAIT.

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: February 14, 2019
• Primary Completion: July 27, 2024
• Study Completion: July 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (1)