Osteoarthritis, KneeNCT03261505

Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain

A study testing Acupuncture in people with Osteoarthritis, Knee, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to investigate brain response and connectivity changes evoked by video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in knee osteoarthritis patients to elucidate the underlying brain mechanisms of mind-body interaction, imagery, and acupuncture. Read more about this study

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Acupuncture
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 125 participants
Where: 1 siteUnited States
Study dates: 4 Aug 2019to 31 Aug 2023
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 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Right-handed
Knee osteoarthritis patients
Ages 40 to 70 years old

Who cannot join

Any contraindications to MRI scanning (claustrophobia, metal implants)
Current or past history of major medical, neurological, or psychiatric illness other than knee osteoarthritis (including high blood pressure, heart disorders, impaired elimination, stomach problems, major kidney or liver problems, bleeding problems, severe dehydration, history of diabetes, history of asthma or other respiratory condition)
Pregnancy
Non fluent English speaker

Trial locations and contacts

1 site in 1 country.

United States1 site

Athinoula A. Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, 02129

Other trials in United States

About this study

Conditions: Osteoarthritis, Knee
Being tested: Acupuncture
Keywords: fMRI, acupuncture, osteoarthritis
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureDevice
Also called Video of Acupuncture
Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.

Study groups in NCT03261505
Study group	Role	What they receive
VGAIT	Experimental	Not described Receives: Device: Acupuncture
VGAIT Control	Sham comparator	Not described Receives: Device: Acupuncture
Real Acupuncture	Active comparator	Not described Receives: Device: Acupuncture
Sham Acupuncture	Placebo comparator	Not described Receives: Device: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

fMRI Signal Increases
fMRI measures changes in brain activity by detecting fluctuations in blood oxygenation levels. The primary signal used in fMRI is the Blood Oxygen Level Dependent (BOLD) signal, which reflects neuronal activity indirectly through hemodynamic responses.
Measured: Collected once during the first treatment session

Secondary outcomes (1)

PAG Resting State Connectivity
The resting state functional connectivity of periaqueduct grey (PAG) before and after intervention. Resting-state functional connectivity (rsFC) is assessed by analyzing spontaneous BOLD signal fluctuations in different brain regions when a subject is at rest, providing insights into intrinsic brain network organization. Preprocessing steps, including motion correction, spatial normalization, and noise removal, ensure data accuracy.
Measured: baseline and after one month treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 201931 Aug 2023

First posted25 Aug 2017
Study start4 Aug 2019
Primary completion29 Aug 2023
Study completion31 Aug 2023

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 Osteoarthritis, KneeStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03261505
Sponsor's protocol ID: 2017P000820
Status last verified: Oct 2025
First submitted: 22 Aug 2017
Last updated: 5 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain
ClinicalTrials.gov ID: NCT03261505
Acronym / sponsor ID: 2017P000820
Conditions: Osteoarthritis, Knee
Keywords: fMRI, acupuncture, osteoarthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 4 Aug 2019 (actual)
Primary completion: 29 Aug 2023 (actual)
Study completion: 31 Aug 2023 (actual)
First posted: 25 Aug 2017 (actual)
Results: Posted 5 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
VGAIT	Experimental	Device: Acupuncture
VGAIT Control	Sham comparator	Device: Acupuncture
Real Acupuncture	Active comparator	Device: Acupuncture
Sham Acupuncture	Placebo comparator	Device: Acupuncture

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Right-handed
Knee osteoarthritis patients
Ages 40 to 70 years old

Key exclusion criteria (4 listed)

Any contraindications to MRI scanning (claustrophobia, metal implants)
Current or past history of major medical, neurological, or psychiatric illness other than knee osteoarthritis (including high blood pressure, heart disorders, impaired elimination, stomach problems, major kidney or liver problems, bleeding problems, severe dehydration, history of diabetes, history of asthma or other respiratory condition)
Pregnancy
Non fluent English speaker

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
AcupunctureAlso: Video of AcupuncturePatients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.	Device	Real Acupuncture, Sham Acupuncture, VGAIT, VGAIT Control

Primary outcome

fMRI Signal Increases
Time frame: Collected once during the first treatment session
fMRI measures changes in brain activity by detecting fluctuations in blood oxygenation levels. The primary signal used in fMRI is the Blood Oxygen Level Dependent (BOLD) signal, which reflects neuronal activity indirectly through hemodynamic responses.

1 secondary outcome

PAG Resting State Connectivity
Time frame: baseline and after one month treatment

Results and safety

Results posted to the registry on 5 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VGAIT	30	27
VGAIT Control	30	27
Real Acupuncture	34	27
Sham Acupuncture	31	28

Primary outcome: fMRI Signal Increases

Time frame: Collected once during the first treatment session. Mean (Standard Deviation). Unit: beta value of bold signal

Measure	VGAIT n = 23	VGAIT Control n = 26	Real Acupuncture n = 24	Sham Acupuncture n = 25
Value	.42 (.27)	.48 (.47)	.47 (.37)	.33 (.32)

Population analysed: SPM 12 was applied to investigate the brain responses to different interactions. Group analysis was performed using a random-effects model. A one-sample t-test was performed to compare the fMRI signal changes during manipulation vs. no manipulation within each treatment. Thresholds of p \< 0.005 were applied. Peak values of fMRI signal increase brain regions (insula) were used for the report below.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through the whole interventions, average about one month.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VGAIT	0 of 30 (0%)	0 of 30 (0%)	0 of 30
VGAIT Control	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Real Acupuncture	0 of 34 (0%)	1 of 34 (2.9%)	0 of 34
Sham Acupuncture	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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 Acupuncture in people with Osteoarthritis, Knee, 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 3 inclusion and 4 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 5 Nov 2025. 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?

Yes. Results are posted in the registry (first posted 5 Nov 2025). 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?

fMRI Signal Increases (time frame: Collected once during the first treatment session). 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 NCT03261505.

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 5 Nov 2025.