Chronic PainNCT03765879
Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back Pain
A study testing Verum VGAIT (Video-Guided Acupuncture Imagery Treatment) in people with Chronic Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
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.
Read the 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).
- Conditions
- Chronic Pain
- Being tested
- Verum VGAIT (Video-Guided Acupuncture Imagery Treatment), Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)Other
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.
Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Verum VGAIT Group | Experimental | Participants in this group will receive verum (real) acupuncture and verum video-guided acupuncture imagery treatment (VGAIT). Receives: Other: Verum VGAIT (Video-Guided Acupuncture Imagery Treatment) |
| Sham VGAIT Group | Placebo comparator | Participants in this group will receive sham acupuncture and sham VGAIT. Receives: Other: Sham VGAIT (Video-Guided Acupuncture Imagery Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (6)
Changes in back-pain specific disability score
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start14 Feb 2019
- Primary completion27 Jul 2024
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765879
- Sponsor's protocol ID
- 2018P002553
- Status last verified
- Jul 2026
- First submitted
- 3 Dec 2018
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hodges S, Li Y, Wu J, Ma L, Liu Y, Reddy S, Sacca V, Walker KM, Chen L, Camprodon JA, Orr SP, Fregni F, Zhang Y, Yao S, Vangel M, Kong J. Novel avatar-based video-guided acupuncture imagery treatment for chronic low back pain: a randomised controlled trial in the USA. EClinicalMedicine. 2025 Oct 10;89:103538. doi: 10.1016/j.eclinm.2025.103538. eCollection 2025 Nov.
PubMed 41140457
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03765879
- Acronym / sponsor ID
- 2018P002553
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 27 Jul 2024 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Verum VGAIT Group | Experimental | Other: Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)Participants in this group will receive verum (real) acupuncture and verum video-guided acupuncture imagery treatment (VGAIT). |
| Sham VGAIT Group | Placebo comparator | Other: Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)Participants in this group will receive sham acupuncture and sham VGAIT. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)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. | Other | Verum VGAIT Group |
| Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)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. | Other | Sham VGAIT Group |
Primary outcome
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.
6 secondary outcomes
Changes in back-pain specific disability score
Time frame: 6 weeks
Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System-29 (PROMIS-29) score
Time frame: 6 weeks
Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System (PROMIS) Global Health score
Time frame: 6 weeks
Changes in psychiatric symptoms as measured by PROMIS-29
Time frame: 6 weeks
Changes in psychiatric symptoms as measured by PROMIS Global Health
Time frame: 6 weeks
Changes in psychiatric symptoms as measured by Beck Depression Inventory (BDI-II)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Derived from this study: PubMed 41140457Hodges S, Li Y, Wu J, Ma L, Liu Y, Reddy S, Sacca V, Walker KM, Chen L, Camprodon JA, Orr SP, Fregni F, Zhang Y, Yao S, Vangel M, Kong J. Novel avatar-based video-guided acupuncture imagery treatment for chronic low back pain: a randomised controlled trial in the USA. EClinicalMedicine. 2025 Oct 10;89:103538. doi: 10.1016/j.eclinm.2025.103538. eCollection 2025 Nov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum VGAIT (Video-Guided Acupuncture Imagery Treatment) in people with Chronic Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in low back pain (LBP) severity score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.