Clinical trial NCT03765879: Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back Pain
Official title: Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, participants will be randomly assigned to receive one of two interventions: verum video-guided acupuncture imagery treatment (VGAIT) or sham VGAIT.
Primary purpose: TREATMENT

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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in low back pain (LBP) severity score
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in back-pain specific disability score
timeFrame: 6 weeks
measure: Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System-29 (PROMIS-29) score
timeFrame: 6 weeks
measure: Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System (PROMIS) Global Health score
timeFrame: 6 weeks
measure: Changes in psychiatric symptoms as measured by PROMIS-29
timeFrame: 6 weeks
measure: Changes in psychiatric symptoms as measured by PROMIS Global Health
timeFrame: 6 weeks
measure: Changes in psychiatric symptoms as measured by Beck Depression Inventory (BDI-II)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: