Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
NCT Number: NCT03765879
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Charlestown, Massachusetts, 02129, United States
Low back pain is the one of the most common reasons for all physician visits in the USA and a leading cause of disability. However, conventional/pharmacological treatments for chronic low back pain (cLBP) have achieved limited success. Imagery is a commonly used therapeutic method for many disorders, such as chronic pain and stroke. Yet, the underlying mechanism remains unclear. Studies suggest that in addition to directly perceiving one's environment, individuals spend considerable time recalling and/or imagining experiences. A large body of literature suggests that common brain areas are activated during direct and vicarious (observational) experiences. Acupuncture is an invasive treatment that involves needle insertion and manipulation. Literature suggests that deqi (sensations evoked by acupuncture needle manipulation, such as soreness, aching, and dull pain) are crucial for treatment effects. In a recent study, the investigators examined video-guided acupuncture imagery treatment ("VGAIT"), during which participants watch a video of acupuncture previously administered on their own body while imagining it being concurrently applied. They found that this treatment can produce deqi sensations and increase pain thresholds in healthy subjects. In this study, the investigators will further investigate the modulation effects of VGAIT on patients with chronic pain.
This study will recruit up to 80 male and female participants, ages 18-60, with a diagnosis of chronic low back pain (having low back pain for more than 6 months), until 60 participants have finished the study. These participants will be randomly assigned to receive VGAIT or sham VGAIT, with 30 in each group.
We first performed a pilot study in which subjects (up to 25) only received real treatment to ensure that the intervention has a treatment effect. In addition, we will also compare the results from the pilot study with previous acupuncture studies from our lab to further validate the effect of VGAIT. If a treatment effect is evident in this pilot cohort, we will begin randomization.
This study consists of 10 sessions over approximately 6 weeks. These sessions include 2 assessment sessions (Session 1 and 10) and 8 treatment sessions (Sessions 2-9). The treatment sessions will consist of verum VGAIT or sham VGAIT. Verum VGAIT will involve the use of acupuncture points commonly used for chronic low back pain. Sham VGAIT will involve the use of non-acupoints.
All study procedures will take place in the department of Psychiatry or the Clinical Research Center at the Martinos Center for Biomedical Imaging (Charlestown Navy Yard Campus of Massachusetts General Hospital).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
Back-pain specific disability will be measured via the Roland-Morris Disability Questionnaire, an instrument that asks participants to describe their low back pain by using 24 questions. Higher scores on this instrument indicate more severe disability.
Time frame: 6 weeks
PROMIS-29 is a 29-item instrument that assesses pain, function, anxiety, and depression. Higher scores can indicate better or worse outcomes, depending on the section of this instrument being scored.
Time frame: 6 weeks
PROMIS Global Health is a 10-item instrument that assesses pain, function, depression, and anxiety. A higher score on this instrument is associated with more improved outcomes in regard to these measures.
Time frame: 6 weeks
PROMIS-29 is a 29-item instrument that assesses pain, function, anxiety, and depression. Higher scores can indicate better or worse outcomes, depending on the section of this instrument being scored.
Time frame: 6 weeks
PROMIS Global Health is a 10-item instrument that assesses pain, function, depression, and anxiety. A higher score on this instrument is associated with more improved outcomes in regard to these measures.
Time frame: 6 weeks
BDI-II is a 210item instrument that is used to measure major depression. Higher scores on this instrument indicate more severe depression symptoms.
Massachusetts General Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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