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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01079390
First received: March 1, 2010
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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 Intervention
Osteoarthritis, Knee
Device: acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: An Acupuncture fMRI Study on Chronic Pain: Response Reliability and Dose Effect

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • fMRI signal changes evoked by different modes acupuncture stimulation [ Time Frame: 5-7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective knee pain rating changes after different treatment [ Time Frame: 5-7 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079390

Locations
United States, Massachusetts
Massachusetts General Hosptial
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Investigators
Principal Investigator: Jian Kong Massachusetts General Hosptial
  More Information

No publications provided

Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01079390     History of Changes
Other Study ID Numbers: 2009-P-000904, 1R21AT004497-01A2
Study First Received: March 1, 2010
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
acupuncture
osteoarthritis
fMRI

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014