Chronic Low-back PainNCT06814470
Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain
A study testing Virtual reality guided imagery acupuncture treatment (VRGAIT) in people with Chronic Low-back Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Testing the effect of Virtual Reality - guided imagery acupuncture Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Virtual reality guided imagery acupuncture treatment (VRGAIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers 18-75 years of age.
- Meet the Classification Criteria of chronic LBP (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 LBP 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.
- Unresolved medical legal/disability/workers compensation claims in connection with low back pain.
- Lacking the capacity to consent for oneself
- Do not have access to zoom or other software regularly to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain
Testing the effect of Virtual Reality - guided imagery acupuncture
Read the detailed description
The aim of this study is to develop a Virtual Reality guided acupuncture imagery treatment system for the treatment of chronic low back pain. This product will provide a new cost-effective treatment option for chronic low back pain and potentially other chronic pain disorders.
- Conditions
- Chronic Low-back Pain
- Being tested
- Virtual reality guided imagery acupuncture treatment (VRGAIT), Virtual reality guided imagery acupuncture treatment control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality guided imagery acupuncture treatment (VRGAIT)Other
Subject watching Virtual reality video of acupuncture needle stimulation
Virtual reality guided imagery acupuncture treatment controlOther
Subject watching VR video of swab touching
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality - guided acupuncture imagery treatment (VRGAIT) | Experimental | Not described Receives: Other: Virtual reality guided imagery acupuncture treatment (VRGAIT) |
| Virtual Reality -guided acupuncture imagery treatment (VRGAIT) Control | Active comparator | Not described Receives: Other: Virtual reality guided imagery acupuncture treatment control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Proportion of subjects who complete all assessments from the total number of subjects who were enrolled in the study
Measured: Through study intervention, an average of about four weeks
Satisfaction to the Interventions
Mean of the satisfaction score on a scale from 1 to 5, larger number indicated greater satisfaction. Assessed after each study interventions, an average score is reported.,
Measured: up to 4 weeks
Number of Adverse Events (Safety of the Intervention)
Symptoms and adverse events reported by the participants
Measured: Through study interventions, an average of about four weeks
Secondary outcomes (4)
PROMIS-29
The PROMIS-29 profile measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain. We use pain intensity in this report, low score indicates improvement.
Measured: baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported.
Pain Bothersomeness Scale
This is a self-reported measure of cLBP pain severity that is commonly used to assess clinical chronic pain. Participants rate how bothersome their LBP was during the previous week with a VAS scale (0-10) from "not at all bothersome" (0) to "extremely bothersome" (10).
Measured: baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported.
MGH Acupuncture Sensation Scale (MASS)
MASS is a scale developed to measure sensations evoked by acupuncture treatment (total range 0-120). The MASS will be applied after each treatment. We reported total score in this report (average of sum of each session). larger numbers indicate stronger sensations.
Measured: up to 4 weeks.
Vividness Scale
Vividness Scale is a 0-10 vividness scale to measure imagery vividness during the intervention. The scale ranges from Not Vivid/Unclear (0) to Vivid/Clear (10).
Measured: After each study interventions, the average score is reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start16 Jul 2024
- Primary completion3 Jan 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low-back 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
- subject will be randomized to 2 groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy Chen, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814470
- Sponsor's protocol ID
- 2018p002553-1
- Status last verified
- Nov 2024
- First submitted
- 28 Jan 2025
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Small Business Act permits NIH SBIR/STTR grantees to withhold data for 4 years after the end of the grant award.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06814470
- Acronym / sponsor ID
- 2018p002553-1
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testing the effect of Virtual Reality - guided imagery acupuncture
Detailed description
The aim of this study is to develop a Virtual Reality guided acupuncture imagery treatment system for the treatment of chronic low back pain. This product will provide a new cost-effective treatment option for chronic low back pain and potentially other chronic pain disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- subject will be randomized to 2 groups
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality - guided acupuncture imagery treatment (VRGAIT) | Experimental | Other: Virtual reality guided imagery acupuncture treatment (VRGAIT) |
| Virtual Reality -guided acupuncture imagery treatment (VRGAIT) Control | Active comparator | Other: Virtual reality guided imagery acupuncture treatment control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers 18-75 years of age.
- Meet the Classification Criteria of chronic LBP (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 LBP 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 (8 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 |
|---|---|---|
| Virtual reality guided imagery acupuncture treatment (VRGAIT)Subject watching Virtual reality video of acupuncture needle stimulation | Other | Virtual Reality - guided acupuncture imagery treatment (VRGAIT) |
| Virtual reality guided imagery acupuncture treatment controlSubject watching VR video of swab touching | Other | Virtual Reality -guided acupuncture imagery treatment (VRGAIT) Control |
Primary outcome
Retention
Time frame: Through study intervention, an average of about four weeks
Proportion of subjects who complete all assessments from the total number of subjects who were enrolled in the study
Satisfaction to the Interventions
Time frame: up to 4 weeks
Mean of the satisfaction score on a scale from 1 to 5, larger number indicated greater satisfaction. Assessed after each study interventions, an average score is reported.,
Number of Adverse Events (Safety of the Intervention)
Time frame: Through study interventions, an average of about four weeks
Symptoms and adverse events reported by the participants
4 secondary outcomes
PROMIS-29
Time frame: baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported.
Pain Bothersomeness Scale
Time frame: baseline, midpoint (week 2), and post-treatment (week 4), the change of score (baseline minus post-treatment) is reported.
MGH Acupuncture Sensation Scale (MASS)
Time frame: up to 4 weeks.
Vividness Scale
Time frame: After each study interventions, the average score is reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The Small Business Act permits NIH SBIR/STTR grantees to withhold data for 4 years after the end of the grant award.
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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 Virtual reality guided imagery acupuncture treatment (VRGAIT) in people with Chronic Low-back 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 8 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: finished, as of the sponsor's last update on 26 Jan 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. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Retention (time frame: Through study intervention, an average of about four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.