Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back Pain
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)
Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Verum VGAIT Group
Sham VGAIT Group
Arm Description
Participants in this group will receive verum (real) acupuncture and verum video-guided acupuncture imagery treatment (VGAIT).
Participants in this group will receive sham acupuncture and sham VGAIT.
Outcomes
Primary Outcome Measures
Changes in low back pain (LBP) severity score
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
Changes in back-pain specific disability score
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.
Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System-29 (PROMIS-29) score
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.
Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System (PROMIS) Global Health score
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.
Changes in psychiatric symptoms as measured by PROMIS-29
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.
Changes in psychiatric symptoms as measured by PROMIS Global Health
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.
Changes in psychiatric symptoms as measured by Beck Depression Inventory (BDI-II)
BDI-II is a 210item instrument that is used to measure major depression. Higher scores on this instrument indicate more severe depression symptoms.
Full Information
NCT ID
NCT03765879
First Posted
December 3, 2018
Last Updated
December 29, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03765879
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Verum VGAIT Group
Arm Type
Experimental
Arm Description
Participants in this group will receive verum (real) acupuncture and verum video-guided acupuncture imagery treatment (VGAIT).
Arm Title
Sham VGAIT Group
Arm Type
Placebo Comparator
Arm Description
Participants in this group will receive sham acupuncture and sham VGAIT.
Intervention Type
Other
Intervention Name(s)
Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)
Intervention Description
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 Measure Information:
Title
Changes in low back pain (LBP) severity score
Description
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
Secondary Outcome Measure Information:
Title
Changes in back-pain specific disability score
Description
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.
Time Frame
6 weeks
Title
Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System-29 (PROMIS-29) score
Description
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
Title
Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System (PROMIS) Global Health score
Description
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
Title
Changes in psychiatric symptoms as measured by PROMIS-29
Description
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
Title
Changes in psychiatric symptoms as measured by PROMIS Global Health
Description
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
Title
Changes in psychiatric symptoms as measured by Beck Depression Inventory (BDI-II)
Description
BDI-II is a 210item instrument that is used to measure major depression. Higher scores on this instrument indicate more severe depression symptoms.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Kong, MD, MS, MPH
Phone
617-726-7893
Email
jkong2@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Georgia Wilson, BA
Phone
617-726-5004
Email
gjwilson@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgia Wilson, BA
Phone
617-726-5004
Email
gjwilson@mgh.harvard.edu
12. IPD Sharing Statement
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Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back Pain
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