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

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

acupuncture

About this trial

This is an interventional basic science trial for Osteoarthritis, Knee focused on measuring acupuncture, osteoarthritis, fMRI

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Massachusetts General Hosptial

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

High dose acupuncture

Low dose acupuncture

placebo acupuncture

Arm Description

six needle applied during acupuncture

two needles will be applied.

sham acupuncture treatment will be applied

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01079390

First Posted

March 1, 2010

Last Updated

July 12, 2017

Sponsor

Massachusetts General Hospital

Collaborators

National Center for Complementary and Integrative Health (NCCIH), Beth Israel Deaconess Medical Center, Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01079390

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Center for Complementary and Integrative Health (NCCIH), Beth Israel Deaconess Medical Center, Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

acupuncture, osteoarthritis, fMRI

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High dose acupuncture

Arm Type

Experimental

Arm Description

six needle applied during acupuncture

Arm Title

Low dose acupuncture

Arm Type

Experimental

Arm Description

two needles will be applied.

Arm Title

placebo acupuncture

Arm Type

Placebo Comparator

Arm Description

sham acupuncture treatment will be applied

Intervention Type

Device

Intervention Name(s)

acupuncture

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

One post-treatment measurement 5-7 weeks after baseline

Title

Cortical Thickness Changes at 5-7 Weeks Post-Treatment

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Kong

Organizational Affiliation

Massachusetts General Hosptial

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hosptial

City

Charlestown

State/Province

Massachusetts

ZIP/Postal Code

02129

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26511911

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.

Results Reference

derived

PubMed Identifier

25258037

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.

Results Reference

derived

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

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