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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01079390
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
National Center for Complementary and Integrative Health (NCCIH)
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: An Acupuncture fMRI Study on Chronic Pain: Response Reliability and Dose Effect
Study Start Date : January 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: High dose acupuncture
six needle applied during acupuncture
Device: acupuncture
patient will receive high dose, low dose or sham acupuncture treatment.

Experimental: Low dose acupuncture
two needles will be applied.
Device: acupuncture
patient will receive high dose, low dose or sham acupuncture treatment.

Placebo Comparator: placebo acupuncture
sham acupuncture treatment will be applied
Device: acupuncture
patient will receive high dose, low dose or sham acupuncture treatment.

Primary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01079390

United States, Massachusetts
Massachusetts General Hosptial
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Principal Investigator: Jian Kong Massachusetts General Hosptial

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital Identifier: NCT01079390     History of Changes
Other Study ID Numbers: 2009-P-000904
1R21AT004497-01A2 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2010    Key Record Dates
Results First Posted: August 10, 2017
Last Update Posted: August 10, 2017
Last Verified: February 2017

Keywords provided by Jian Kong, Massachusetts General Hospital:

Additional relevant MeSH terms:
Chronic Pain
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms