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

NCT01079390 | Completed Results DMC

• 2 other identifiers: 2009-P-0009041R21AT004497-01A2
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

acupuncture; osteoarthritis; fMRI

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline

Study Arms (3)

High dose acupuncture

EXPERIMENTAL

six needle applied during acupuncture

Device: acupuncture

Low dose acupuncture

EXPERIMENTAL

two needles will be applied.

Device: acupuncture

placebo acupuncture

PLACEBO COMPARATOR

sham acupuncture treatment will be applied

Device: acupuncture

Interventions

acupuncture DEVICE

patient will receive high dose, low dose or sham acupuncture treatment.

High dose acupuncture; Low dose acupuncture; placebo acupuncture

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Massachusetts General Hosptial

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (2)

• 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.

  PMID: 26511911 DERIVED

• 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.

  PMID: 25258037 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

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.

Results Point of Contact

• Title: Jian Kong
• Organization: Mass General Hospital

kongj@nmr.mgh.harvard.edu

617-726-7893

Study Officials

• Jian Kong

  Massachusetts General Hosptial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 3, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: November 1, 2014
• Last Updated: August 10, 2017
• Results First Posted: August 10, 2017

Record last verified: 2017-02

Locations

US (1)