Clinical trial NCT01079390: An Acupuncture Functional Magnetic Resonance Imaging (fMRI) Study on Chronic Pain: Response Reliability and Dose Effect
Official title: An Acupuncture fMRI Study on Chronic Pain: Response Reliability and Dose Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: acupuncture
osteoarthritis
fMRI
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
First posted: 2010-03-03
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Volunteers 40-70 years of age.
2. 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.
3. Radiographic evidence of Grade 2 or 3 knee OA using the Kellgren-Lawrence Scale \[78, 85-87\].
4. 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.
5. 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:

1. Any interventional procedure for knee pain, including corticosteroid injections (within 6 months, \[88\]) to the knee.
2. 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.
3. The intent to undergo surgery during the time of involvement in the study.
4. 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.
5. 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.
6. Non-ambulatory status.
7. 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.
8. Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment
timeFrame: One post-treatment measurement 5-7 weeks after baseline
measure: Cortical Thickness Changes at 5-7 Weeks Post-Treatment
timeFrame: 2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hosptial
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hosptial
name: Jian Kong
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.