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Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03765879
Recruitment Status : Not yet recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Other: Verum VGAIT (Video-Guided Acupuncture Imagery Treatment) Other: Sham VGAIT (Video-Guided Acupuncture Imagery Treatment) Not Applicable

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. The first several participants (up to 10) will only receive real treatment to ensure that the intervention has an apparent treatment effect. If a treatment effect is evident in this pilot cohort, we will begin randomization.

This study consists of 8 sessions over approximately 6 weeks. These sessions include 2 assessment sessions (Session 1 and 8) and 6 treatment sessions (Sessions 2-7). 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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description: This experiment will not be blinded. Participants will be aware if they are in the verum VGAIT or sham VGAIT group by nature of the interventions.
Primary Purpose: Treatment
Official Title: Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back Pain
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Verum VGAIT Group
Participants in this group will receive verum (real) acupuncture and verum video-guided acupuncture imagery treatment (VGAIT).
Other: Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)
In VGAIT treatment sessions, participants will re-watch the video of themselves receiving acupuncture treatment, and they will be asked to vividly imagine that the treatment is being concurrently applied.

Placebo Comparator: Sham VGAIT Group
Participants in this group will receive sham acupuncture and sham VGAIT.
Other: Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)
In sham VGAIT treatment sessions, participants will re-watch this video of themselves receiving the sham acupuncture treatment, and they will be asked to vividly imagine that the treatment is being concurrently applied.




Primary Outcome Measures :
  1. Changes in low back pain (LBP) severity score [ 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.


Secondary Outcome Measures :
  1. Changes in back-pain specific disability score [ Time Frame: 6 weeks ]
    Back-pain specific disability will be measured via the Owestry Low Back Pain Disability Questionnaire, an instrument that asks participants to describe their low back pain by checking statements that are most applicable to their pain. The instrument is scored based on disability severity over ten different areas (such as personal care and walking abilities). Higher scores on this instrument indicate more severe disability.

  2. Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System-29 (PROMIS-29) score [ 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.

  3. Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System (PROMIS) Global Health score [ 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.

  4. Changes in psychiatric symptoms as measured by PROMIS-29 [ 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.

  5. Changes in psychiatric symptoms as measured by PROMIS Global Health [ 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.

  6. Changes in psychiatric symptoms as measured by Beck Depression Inventory (BDI-II) [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765879


Contacts
Contact: Jian Kong, MD, MS, MPH 617-726-7893 jkong2@mgh.harvard.edu
Contact: Georgia Wilson, BA 617-726-5004 gjwilson@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: Jian Kong, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03765879     History of Changes
Other Study ID Numbers: 2018P002553
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms