Osteoarthritis, KneeNCT01079390

An Acupuncture Functional Magnetic Resonance Imaging (fMRI) Study on Chronic Pain: Response Reliability and Dose Effect

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

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: 44 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Nov 2014
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

Volunteers 40-70 years of age.
Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the left / right knee for at least the past 3 months, as determined by the referring physician.
Radiographic evidence of Grade 2 or 3 knee OA using the Kellgren-Lawrence Scale [78, 85-87].
Patients must have moderate or greater clinically significant pain on most days during the past month (more than 15 days out of 30, of average daily pain of >3/10) in the left or right knee.
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

Any interventional procedure for knee pain, including corticosteroid injections (within 6 months, [88]) to the knee.
Prior acupuncture treatment for any condition. Because we are using a placebo needle as a control, acupuncture-naive patients are necessary to maximize the benefits of blinding and to control expectancy.
The intent to undergo surgery during the time of involvement in the study.
Presence of any illness or medication use that is judged to interfere with the trial. For example: skin irritations around the knee such as psoriasis; bleeding disorders or anticoagulant use that would be contraindications for acupuncture; opioids or benzodiazepines, which may alter pain sensitivity and BOLD response.
Knee pain due to other causes, such as inflammation or malignancy, other pain disorders that may refer pain to the leg, OA of ipsilateral hip, diagnosis of RA.
Non-ambulatory status.
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.
Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hosptial
Charlestown, Massachusetts, 02129

Other trials in United States

About this study

Official title: An Acupuncture fMRI Study on Chronic Pain: Response Reliability and Dose Effect

In this proposal, we plan to dynamically investigate brain response to verum acupuncture (of two different "doses") and placebo acupuncture, using a paradigm that approximates clinical acupuncture practice across multiple treatment sessions in knee osteoarthritis (OA) patients. This proposal aims to: 1) characterize session-to-session brain responses to verum / sham acupuncture treatment (reliability of response) for OA patients, and 2) investigate how different "doses" of acupuncture influence brain response and acupuncture efficacy (impact of dose). The findings of this project will deepen our biological understanding on why and how acupuncture can treat chronic pain and what happens in the brain during the multiple-session acupuncture treatment.

Conditions: Osteoarthritis, Knee
Being tested: acupuncture
Keywords: acupuncture, osteoarthritis, fMRI
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
patient will receive high dose, low dose or sham acupuncture treatment.

Study groups in NCT01079390
Study group	Role	What they receive
High dose acupuncture	Experimental	six needle applied during acupuncture Receives: Device: acupuncture
Low dose acupuncture	Experimental	two needles will be applied. Receives: Device: acupuncture
placebo acupuncture	Placebo comparator	sham acupuncture treatment will be applied Receives: Device: acupuncture

What is being measured

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

Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment
The Knee injury and Osteoarthritis Outcome Score (KOOS) was used to measure clinical outcomes. KOOS is measured on a scale from 0-4 with 0 being no pain and 4 being extreme pain (the worst). The KOOS is comprised of 5 subscales, each of which produces an outcome score. These subscales include pain, other symptoms, function in daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL). Based on previous studies, subscale scores of the KOOS related to pain, function in daily living, and function in sport and recreation were selected as the primary outcome of the present study. For each subscale, a normalized score was calculated, where 0 indicated the most extreme symptoms/pain and 100 indicated no symptoms/pain.
Measured: One post-treatment measurement 5-7 weeks after baseline
Cortical Thickness Changes at 5-7 Weeks Post-Treatment
All eligible patients were scanned using fMRI while receiving treatment during acupuncture sessions 1, 3, and 6. Structural MRI data were only compared between Session 1 (pre-treatment) and Session 6 (post-treatment). The structural data was analyzed using FreeSurfer software.
Measured: 2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline

Timeline

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

Jan 2010Nov 2014

First posted3 Mar 2010 (estimated)
Study startJan 2010
Primary completionJan 2013
Study completionNov 2014

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.
Publications (2)Papers the sponsor has linked to this study.
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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01079390
Sponsor's protocol ID: 2009-P-000904
Other IDs: 1R21AT004497-01A2
Status last verified: Feb 2017
First submitted: 1 Mar 2010
Last updated: 10 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chen X, Spaeth RB, Freeman SG, Scarborough DM, Hashmi JA, Wey HY, Egorova N, Vangel M, Mao J, Wasan AD, Edwards RR, Gollub RL, Kong J. The modulation effect of longitudinal acupuncture on resting state functional connectivity in knee osteoarthritis patients. Mol Pain. 2015 Oct 29;11:67. doi: 10.1186/s12990-015-0071-9.
PubMed 26511911
Chen X, Spaeth RB, Retzepi K, Ott D, Kong J. Acupuncture modulates cortical thickness and functional connectivity in knee osteoarthritis patients. Sci Rep. 2014 Sep 26;4:6482. doi: 10.1038/srep06482.
PubMed 25258037

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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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 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Acupuncture fMRI Study on Chronic Pain: Response Reliability and Dose Effect
ClinicalTrials.gov ID: NCT01079390
Acronym / sponsor ID: 2009-P-000904
Conditions: Osteoarthritis, Knee
Keywords: acupuncture, osteoarthritis, fMRI
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH), Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
Study start: Jan 2010
Primary completion: Jan 2013 (actual)
Study completion: Nov 2014 (actual)
First posted: 3 Mar 2010 (estimated)
Results: Posted 10 Aug 2017

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: 3

Arm	Type	Receives
High dose acupuncture	Experimental	Device: acupuncturesix needle applied during acupuncture
Low dose acupuncture	Experimental	Device: acupuncturetwo needles will be applied.
placebo acupuncture	Placebo comparator	Device: acupuncturesham acupuncture treatment will be applied

Who may qualify

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

Key inclusion criteria (5 listed)

Volunteers 40-70 years of age.
Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the left / right knee for at least the past 3 months, as determined by the referring physician.
Radiographic evidence of Grade 2 or 3 knee OA using the Kellgren-Lawrence Scale [78, 85-87].
Patients must have moderate or greater clinically significant pain on most days during the past month (more than 15 days out of 30, of average daily pain of >3/10) in the left or right knee.
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)

Any interventional procedure for knee pain, including corticosteroid injections (within 6 months, [88]) to the knee.
Prior acupuncture treatment for any condition. Because we are using a placebo needle as a control, acupuncture-naive patients are necessary to maximize the benefits of blinding and to control expectancy.
The intent to undergo surgery during the time of involvement in the study.
Presence of any illness or medication use that is judged to interfere with the trial. For example: skin irritations around the knee such as psoriasis; bleeding disorders or anticoagulant use that would be contraindications for acupuncture; opioids or benzodiazepines, which may alter pain sensitivity and BOLD response.
Knee pain due to other causes, such as inflammation or malignancy, other pain disorders that may refer pain to the leg, OA of ipsilateral hip, diagnosis of RA.

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
acupuncturepatient will receive high dose, low dose or sham acupuncture treatment.	Device	High dose acupuncture, Low dose acupuncture, placebo acupuncture

Primary outcome

Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment
Time frame: One post-treatment measurement 5-7 weeks after baseline
The Knee injury and Osteoarthritis Outcome Score (KOOS) was used to measure clinical outcomes. KOOS is measured on a scale from 0-4 with 0 being no pain and 4 being extreme pain (the worst). The KOOS is comprised of 5 subscales, each of which produces an outcome score. These subscales include pain, other symptoms, function in daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL). Based on previous studies, subscale scores of the KOOS related to pain, function in daily living, and function in sport and recreation were selected as the primary outcome of the present study. For each subscale, a normalized score was calculated, where 0 indicated the most extreme symptoms/pain and 100 indicated no symptoms/pain.
Cortical Thickness Changes at 5-7 Weeks Post-Treatment
Time frame: 2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline
All eligible patients were scanned using fMRI while receiving treatment during acupuncture sessions 1, 3, and 6. Structural MRI data were only compared between Session 1 (pre-treatment) and Session 6 (post-treatment). The structural data was analyzed using FreeSurfer software.

Results and safety

Results posted to the registry on 10 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Dose Acupuncture	15	10
Low Dose Acupuncture	15	10
Placebo Acupuncture	14	10

Primary outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment

Time frame: One post-treatment measurement 5-7 weeks after baseline. Mean (Standard Deviation). Unit: units on KOOS scale

Measure	High Dose Acupuncture n = 10	Low Dose Acupuncture n = 10	Placebo Acupuncture n = 10
Value	59 (13)	53 (9)	56 (19)

Primary outcome: Cortical Thickness Changes at 5-7 Weeks Post-Treatment

Time frame: 2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline. Mean (Standard Deviation). Unit: millimeters

Measure	Acupuncture n = 20	Placebo Acupuncture n = 10
Value	2.9 (0.15)	3.13 (0.28)

Population analysed: We combined low and high dose acupuncture into one group because we found there were not clinical differences between the two group.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Dose Acupuncture	0 of 15 (0%)	0 of 15 (0%)	Not reported
Low Dose Acupuncture	0 of 15 (0%)	0 of 15 (0%)	Not reported
Placebo Acupuncture	0 of 14 (0%)	0 of 14 (0%)	Not reported

Limitations and caveats (from the sponsor): Limitations of the study are the small sample size as well as the effects of factors such as age, gender, and chronic duration of pain.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26511911Chen X, Spaeth RB, Freeman SG, Scarborough DM, Hashmi JA, Wey HY, Egorova N, Vangel M, Mao J, Wasan AD, Edwards RR, Gollub RL, Kong J. The modulation effect of longitudinal acupuncture on resting state functional connectivity in knee osteoarthritis patients. Mol Pain. 2015 Oct 29;11:67. doi: 10.1186/s12990-015-0071-9.
Derived from this study: PubMed 25258037Chen X, Spaeth RB, Retzepi K, Ott D, Kong J. Acupuncture modulates cortical thickness and functional connectivity in knee osteoarthritis patients. Sci Rep. 2014 Sep 26;4:6482. doi: 10.1038/srep06482.

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
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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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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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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.

Jian Kong principal investigator

Massachusetts General Hosptial

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 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 10 Aug 2017. 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 10 Aug 2017). 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?

Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment (time frame: One post-treatment measurement 5-7 weeks after baseline). The study lists 2 primary outcomes in all. 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 NCT01079390, which also lists 2 linked publications.

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 10 Aug 2017.