A Feasibility Study of Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain
Phase: NA
Conditions: Chronic Low-back Pain
Sponsor: Massachusetts General Hospital

 
Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain 
 
NCT06814470 
 
07/15/2024 
 
 

The use of imagery to treat illness has a long history in medical practice. Although still under 
investigation, research findings support the notion that the brain responds in similar ways to 
imagined experiences as it does to actual experience. Thus, underlying the functional nature of 
mental imagery may be shared neurocognitive operations that support both imagination and 
perception. Acupuncture is a unique, invasive treatment modality and has been recommended 
for the treatment of cLBP by the American College of Physicians.  Studies have shown that the 
experience of acupuncture needle stimulation and the visualization of acupuncture needle 
stimulation can provoke overlapping activations in brain regions, such as the anterior insula (AI), 
anterior cingulate cortex (ACC), and periaqueductal grey (PAG).  
Based on above findings, the PI and his team developed a new treatment modality, whereby 
participants watch a 2-dimensional (2D) video of acupuncture that was previously administered 
to their own body and imagine it being concurrently applied, viz., 2D video-guided acupuncture 
imagery treatment (2D-VGAIT). We found that 2D-VGAIT can produce an analgesic effect in 
healthy subjects. In a more recent pilot study, we found that 2D-VGAIT can produce comparable 
symptom relief to real acupuncture after a 1-month (6 treatments) intervention in cLBP patients. 
Nevertheless, the reality simulation of 2D-VGAIT can be improved. 
Recently, Virtual Reality (VR) has drawn the attention of researchers. VR allows for the 
simulation of physical presence in the real or imagined worlds. As a powerful tool for studying 
body representation and creating perceptual body-ownership transfer illusions, literature 
suggests that VR is more effective in reducing pain than 2D screen applications. This unique 
property of VR may further increase 2D-VGAIT’s efficacy.  
Specific Aim: Perform a feasibility study of cLBP treatment using the developed VRGAIT 
system. cLBP patients will be recruited and randomized to VRGAIT and VRGAIT control 
conditions. Primary outcomes will be feasibility-related assessments (recruitment, retention, 
fidelity, satisfaction, and safety). Secondary outcomes will be clinical outcomes, presence, 
imagery vividness, and acupuncture deqi sensations.  
Detailed experimental procedure 
Subject recruitment. Patients with non-specific cLBP will be recruited.  
Randomization. Patients who pass the screening will be randomized to the VRGAIT or 
VRGAIT control group using a centrally generated, variable-sized block design.  
Endpoints. Primary outcomes will be feasibility-related outcomes such as recruitment, 
retention, fidelity, satisfaction, and safety. Secondary outcomes will include clinical outcomes 
and vividness and presence scales. 
Blinding. Due to the nature of the intervention, patients cannot be blinded as to whether they 
receive VRGAIT or VRGAIT control. All outcome assessors will be blinded to the treatment each 
patient receives.  
Session 1 will be a baseline session that will include clinical outcome measures and other 
related assessments and videotaping for VRGAIT treatment. Similar to our previous studies, we 
will explain the potential underlying mechanism of how imagery treatment works and the 
procedures for this study. Next, the subject will receive: 1) a brief, real acupuncture treatment, 

which will be videotaped using a VR camera; 2) a cotton swab touching non-acupuncture sites, 
which will also be videotaped as a VRGAIT control condition. All subjects will experience brief 
acupuncture and swab touch to avoid the potential confounding provoked by brief acupuncture 
treatment. Subjects will then be introduced to the MGH Acupuncture Sensation Scale (MASS) to 
report the sensations they experienced during acupuncture treatment and cotton swab touch. 
Outcomes 
Participant Satisfaction Survey is a 5-point Likert scale (5 = very satisfied; 1 = completely 
dissatisfied) used to assess participant satisfaction at the end of the study. 
29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29): We will 
use PROMIS-29 to assess pain intensity (using an 11-point numeric rating scale [NRS]), 
physical function, depression, anxiety, fatigue, sleep disturbance, interference and social role, 
and activity in the past 7 days. 
Pain Bothersomeness Scale: 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).  
MGH Acupuncture Sensation Scale (MASS)  is a scale developed to measure sensations 
evoked by acupuncture treatment. The MASS will be applied after each treatment. 
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).  
Symptoms and Adverse Events: Symptoms and adverse events during or after treatment will be 
recorded after each treatment.  
Sessions 2-7 will be treatment sessions. Subjects will receive VRGAIT or the VRGAIT control 
based on the randomization across 4 weeks (2 times per week during weeks 1-2, 1 time per 
week during weeks 3-4). 
Session 8 will be an assessment session identical to Session 1.