Acupuncture Imagery for Low Back Pain

Overseen By Georgia Wilson, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cancer, Fractures, Infections, others

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether video-guided acupuncture imagery can reduce chronic low back pain. Participants will be divided into two groups: one receiving real acupuncture with imagery treatment (Verum VGAIT) and the other receiving a fake version of both (Sham VGAIT). The main goal is to observe changes in pain levels after each of the six treatment sessions over six weeks. Individuals who have experienced low back pain for more than six months and rate their pain at least a 4 out of 10 may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that video-guided acupuncture imagery treatment is safe for low back pain?

Research shows that video-guided acupuncture imagery treatment (VGAIT) is generally safe. No reports of serious side effects from VGAIT itself exist. Acupuncture is usually well-tolerated, with most people experiencing only mild discomfort, such as slight pain or temporary redness at needle sites.

This trial lacks a specific phase, indicating that the treatment is still under study for safety and effectiveness. However, since acupuncture is an established method and VGAIT merely adds video guidance, it is likely safe. Further studies will help confirm this. Always consult healthcare professionals if there are concerns about joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Verum VGAIT for low back pain because it combines real acupuncture with innovative video-guided acupuncture imagery treatment (VGAIT). Unlike standard treatments like pain medications, physical therapy, or traditional acupuncture, this approach uses visual imagery to potentially enhance the effects of acupuncture. The unique integration of video guidance aims to engage patients' minds, potentially improving pain management by leveraging both physical and mental therapeutic pathways. This dual approach might offer a more holistic and effective pain relief experience for patients suffering from low back pain.

What evidence suggests that video-guided acupuncture imagery treatment is effective for low back pain?

Research has shown that video-guided acupuncture imagery treatment (VGAIT) can help reduce chronic low back pain. One study found that VGAIT significantly eased pain after just four weeks. Another study discovered that real acupuncture helped balance brain activity linked to pain. In this trial, participants in the Verum VGAIT Group will receive real acupuncture and verum VGAIT, while those in the Sham VGAIT Group will receive sham acupuncture and sham VGAIT. Results indicated that both real and imagined acupuncture treatments reduced pain severity. These findings suggest that VGAIT could effectively relieve chronic low back pain. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with chronic low back pain lasting more than 6 months, rated at least 4/10 in intensity. Participants must have had their condition evaluated by a healthcare provider and be able to understand English well. Excluded are those with specific causes of back pain like cancer or fractures, intent to undergo surgery soon, unresolved legal claims related to back pain, active substance abuse within the last two years, prior complicated back issues including surgery, contraindications for acupuncture such as pregnancy or coagulation disorders.

Inclusion Criteria

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.

Exclusion Criteria

Specific causes of back pain (e.g. cancer, fractures, infections),

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo initial assessment to establish baseline measures

1 week

1 visit (in-person)

Treatment

Participants receive 6 treatment sessions of either verum or sham VGAIT over 6 weeks

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for changes in low back pain severity and other outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham VGAIT
• Verum VGAIT

Trial Overview The study tests 'video-guided acupuncture imagery treatment' (VGAIT) against sham VGAIT for relieving chronic low back pain. Over six weeks, participants will attend eight sessions which include six treatments. The main goal is to see if there's a change in the severity of low back pain after each session using VGAIT compared to fake treatments.

How Is the Trial Designed?

Group I: Verum VGAIT Group Experimental Treatment 1 Intervention

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

Group II: Sham VGAIT Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03765879

Brain Mechanisms of Video-Guided Acupuncture Imagery ... The primary outcome measure for this study is change in low back pain severity score after each treatment session. Detailed Description. Low back pain is the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32684925/

Imagined and Actual Acupuncture Effects on Chronic Low ... Results: All three treatments (VGAIT, real, and sham acupuncture) significantly reduced pain severity as measured by a low back pain ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213158215001722

Repeated verum but not placebo acupuncture normalizes ... This study shows that repeated verum acupuncture might act by restoring the balance in the connectivity of the key pain brain regions.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12547178/

Novel avatar-based video-guided acupuncture imagery ... In this study, we found that a 4-week intervention of video-guided acupuncture imagery treatment (VGAIT) significantly relieved chronic low back ...

5. thelancet.com thelancet.com/cms/10.1016/j.eclinm.2025.103538/attachment/655a80cf-8429-4d74-90f2-137f7424ca3b/mmc1.docx

Document (110.16 KB) Hypothesis: Eight sessions of VGAIT (video-guided acupuncture imagery treatment) will significantly reduce chronic low back pain, and the pain rating reduction ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7350074/

Imagined and Actual Acupuncture Effects on Chronic Low ... The aim of this study is to extend our previous finding by investigating whether VGAIT can relieve symptoms in patients with chronic low back pain.

7. withpower.com withpower.com/trial/phase-low-back-pain-1-2019-55439

Acupuncture Imagery for Low Back Pain · Info for Participants In this study, the investigators will examine the analgesic effects of acupuncture imagery treatment in patients with chronic low back pain.