Virtual Reality Guided Acupuncture for Low Back Pain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cancer, Fractures, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Testing the effect of Virtual Reality - guided imagery acupuncture

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 data supports the effectiveness of the treatment Virtual Reality Guided Acupuncture Imagery Treatment for low back pain?

Research shows that acupuncture, which is part of this treatment, is frequently used for low back pain and involves specific points on the body that are targeted to relieve pain. Studies have visualized these acupuncture points and their effectiveness, suggesting that acupuncture can be beneficial for managing low back pain. ^{1 2 3 4 5}

Is Virtual Reality Guided Acupuncture safe for humans?

The research on acupuncture for low back pain suggests it is generally safe, but the specific safety of Virtual Reality Guided Acupuncture has not been directly studied in these articles. ^{1 6 7 8 9}

What makes Virtual Reality Guided Acupuncture Imagery Treatment unique for low back pain?

This treatment combines virtual reality with acupuncture, offering a novel approach by using immersive technology to guide and enhance the acupuncture experience, potentially making it more accessible and effective for beginners and those unfamiliar with traditional acupuncture methods. ^{1 2 3 10 11}

Eligibility Criteria

This trial is for adults aged 18-75 with chronic low back pain lasting more than 6 months, who can read English at a 10th-grade level. Participants must have had their condition evaluated by a healthcare provider and experience pain of at least 4/10 on the intensity scale. Excluded are those without regular software access, complex back issues, intent to undergo surgery soon, certain medical conditions like coagulation disorders or severe psychological problems.

Inclusion Criteria

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

I have had low back pain for over 6 months.

I am between 18 and 75 years old.

Exclusion Criteria

Do not have access to zoom or other software regularly to complete the study

I have had back surgery or legal issues related to my back condition.

I plan to have surgery while participating in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Virtual Reality guided acupuncture imagery treatment for chronic low back pain

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Virtual Reality Guided Acupuncture Imagery Treatment

Trial Overview The study tests Virtual Reality Guided Imagery Acupuncture Treatment (VRGAIT) against a control version for treating chronic low back pain. It aims to see if VR can enhance the effects of imagery acupuncture treatment in reducing pain and improving quality of life.

Participant Groups

Group I: Virtual Reality - guided acupuncture imagery treatment (VRGAIT) Experimental Treatment 1 Intervention

Group II: Virtual Reality -guided acupuncture imagery treatment (VRGAIT) Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

The study evaluated a simulated acupuncture technique involving toothpick insertions as a control treatment in randomized trials for low-back pain, finding it to be a reasonable alternative for acupuncture-naïve participants.

Participants receiving real acupuncture reported more immediate pain relief compared to those receiving simulated treatment, suggesting that actual needling may provide a more effective therapeutic effect, which could influence perceptions of treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description and validation of a noninvasive placebo acupuncture procedure. Sherman, KJ., Hogeboom, CJ., Cherkin, DC., et al.[2022]

The study utilized a 3D reconstruction of tissues around the Jianliao (TE 14) acupuncture point to help beginners understand the mechanics of acupuncture through virtual reality.

Using the VOXEL-MAN platform, operators could experience realistic mechanical changes during acupuncture, allowing for effective imitation and practice of needling techniques with force feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study on force feedback of acupuncture manipulation at Jianliao (TE 14) based on VOXEL-MAN]. Wang, HS., Yan, ZG., Cheng, Z., et al.[2013]

A review of 37 clinical studies on acupuncture for low-back pain identified key acupoints, with BL23 being the most frequently used (51%), indicating their importance in treatment efficacy.

The study proposes a new 3D model to visualize the meridian system and acupoints, which could enhance understanding and effectiveness of acupuncture treatments by correlating disease locations with specific acupoint usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visualization of the Meridian System Based on Biomedical Information about Acupuncture Treatment. Lee, IS., Lee, SH., Kim, SY., et al.[2021]

The study successfully recruited 45 participants with chronic low back pain, achieving a high randomization rate of 100% and treatment compliance of 86.7% to 100% across different acupuncture session groups.

Secondary outcomes showed that participants receiving 10 sessions of acupuncture reported better back function and overall satisfaction, with over 90% expressing high levels of satisfaction with the treatment, indicating potential benefits of increased treatment frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic low back pain: a randomized controlled feasibility trial comparing treatment session numbers. Liu, L., Skinner, MA., McDonough, SM., et al.[2018]

In a pilot study involving 20 patients with chronic low back pain, 10 sessions of individualized acupuncture led to significant improvements in pain and quality of life measures, with a 40% reduction in pain levels observed at the 6-month follow-up.

The study's results suggest that acupuncture may be an effective treatment for low back pain, warranting further investigation in a randomized controlled trial, although improvements could also be influenced by the natural progression of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for low back pain: results of a pilot study for a randomized controlled trial. MacPherson, H., Gould, AJ., Fitter, M.[2019]

In a study of 142 patients with chronic low back pain, higher pre-treatment expectations about minimal acupuncture treatment were linked to greater reductions in pain intensity after the first four sessions.

However, these expectations did not significantly influence pain outcomes by the end of the treatment, suggesting that other factors may become more important as treatment progresses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do patients' pre-treatment expectations about acupuncture effectiveness predict treatment outcome in patients with chronic low back pain? A secondary analysis of data from a randomised controlled clinical trial. Zieger, A., Kern, A., Barth, J., et al.[2022]

This study aims to evaluate the effectiveness and safety of acupuncture for chronic low back pain (CLBP) in a real-world setting, involving at least 2000 patients across 27 acupuncturists and 9 medical centers.

The research will assess pain and functional disability using standardized measures and explore factors influencing acupuncture's effectiveness, providing valuable insights beyond traditional randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture therapy for chronic low back pain: protocol of a prospective, multi-center, registry study. Wei, X., Liu, B., He, L., et al.[2020]

In a study of 55 older patients with chronic low back pain, those receiving biweekly acupuncture showed a significant improvement in disability scores compared to those receiving standard care alone, with a notable decrease in the modified Roland Disability Questionnaire score at week 6 (4.1 vs. 0.7).

Acupuncture not only provided effective pain relief but also resulted in fewer medication-related side effects, highlighting its safety as an adjunctive treatment for chronic low back pain in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic low back pain in older patients: a randomized, controlled trial. Meng, CF., Wang, D., Ngeow, J., et al.[2007]

A systematic review of 35 low back pain guidelines revealed that acupuncture is mentioned in 23 of them, with 20% recommending its use for treatment.

Most guidelines were published in the last 20 years, primarily from the United States and Europe, indicating a growing interest in evidence-based approaches to managing low back pain, although many guidelines still do not endorse acupuncture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current status of application of acupuncture in low back pain guidelines]. Yang, XY., Zhao, H., Liu, J., et al.[2019]

A virtual reality system has been developed to assist novices in performing hand acupuncture (sujichim) at home, making it accessible for personal health care.

Experiments demonstrated that this system is both effective and user-friendly, allowing individuals to improve their body condition through self-administered acupuncture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A virtual reality system for hand acupuncture. Kim, KH., Choi, YK., Lee, ET., et al.[2004]

Out of 24 randomized controlled trials (RCTs) of acupuncture for chronic low back pain, only 6 (25%) were rated as 'good' according to Chinese textbook standards, indicating a need for improved adherence to established acupuncture practices.

The study found a strong correlation (0.85) between expert ratings of acupuncture quality and the Low Back Pain Acupuncture Score (LBPAS), suggesting that the LBPAS is a reliable tool for assessing acupuncture quality in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An international expert survey on acupuncture in randomized controlled trials for low back pain and a validation of the low back pain acupuncture score. Molsberger, A., Zhou, J., Boewing, L., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Description and validation of a noninvasive placebo acupuncture procedure. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Study on force feedback of acupuncture manipulation at Jianliao (TE 14) based on VOXEL-MAN]. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Visualization of the Meridian System Based on Biomedical Information about Acupuncture Treatment. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic low back pain: a randomized controlled feasibility trial comparing treatment session numbers. [2018]

5. Scotland pubmed.ncbi.nlm.nih.gov

Acupuncture for low back pain: results of a pilot study for a randomized controlled trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Do patients' pre-treatment expectations about acupuncture effectiveness predict treatment outcome in patients with chronic low back pain? A secondary analysis of data from a randomised controlled clinical trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Acupuncture therapy for chronic low back pain: protocol of a prospective, multi-center, registry study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic low back pain in older patients: a randomized, controlled trial. [2007]

9. China pubmed.ncbi.nlm.nih.gov

[Current status of application of acupuncture in low back pain guidelines]. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A virtual reality system for hand acupuncture. [2004]

11. England pubmed.ncbi.nlm.nih.gov

An international expert survey on acupuncture in randomized controlled trials for low back pain and a validation of the low back pain acupuncture score. [2021]