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Brain Imaging Study of Acupuncture in Chronic Low Back Pain

Primary Purpose

Low Back Pain, Back Pain Lower Back Chronic, Low Back Pain, Recurrent

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Back Pain focused on measuring Acupuncture, fMRI, CLBP, Pain, Low Back Pain, Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician
  • At least 4/10 clinical pain on the 10-point LBP intensity scale on average during the past two weeks prior to enrollment
  • 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
  • Must have had a prior evaluation of their low back pain by a health care provider, which may include radiographic studies. Documentation of this evaluation will be obtained from the subject's medical record

Exclusion Criteria:

  • Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)
  • Radicular pain extending below the knee
  • Complicated back problems (e.g., prior back surgery, medicolegal issues)
  • Possible contraindications for acupuncture (e.g., coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis)
  • Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator and/or a T score > 60 on the psychological measures assessed during Session 1)
  • Prior acupuncture treatment for back pain; 1 year minimum wait for any condition other condition.
  • Active substance abuse disorder in the past two years, as determined by subject self-report.
  • The intent to undergo surgery during the time of involvement in the study.
  • 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 MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
  • Unresolved legal/disability/workers compensation claims in connection with low back.
  • Instability of pain ratings in Session 2 or Session 3.
  • Use of more than 60 mg prescription opioids or steroids for pain.

Sites / Locations

  • MGH - Martinos Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Traditional Acupuncture

Electroacupuncture

Arm Description

Traditional Acupuncture given at 2 visits.

Electro-acupuncture given at 2 visits.

Outcomes

Primary Outcome Measures

Brain changes to acupuncture
The effects of pain on the brain

Secondary Outcome Measures

Full Information

First Posted
May 23, 2012
Last Updated
November 27, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01614639
Brief Title
Brain Imaging Study of Acupuncture in Chronic Low Back Pain
Official Title
A Physiological fMRI Study of Acupuncture and Perceptions of Pain in Chronic Low Back Pain Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We are doing this research study to learn about how acupuncture treatment works. This study is being done to look at changes in the brain, NOT to treat pain. We want to learn about brain activity during acupuncture. We will look at brain activity when a heating device touches the skin of a subject before and after the subject has acupuncture, to see what changes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Back Pain Lower Back Chronic, Low Back Pain, Recurrent
Keywords
Acupuncture, fMRI, CLBP, Pain, Low Back Pain, Back Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Acupuncture
Arm Type
Experimental
Arm Description
Traditional Acupuncture given at 2 visits.
Arm Title
Electroacupuncture
Arm Type
Experimental
Arm Description
Electro-acupuncture given at 2 visits.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
A licensed acupuncturist will perform acupuncture for two 30 minute sessions.
Primary Outcome Measure Information:
Title
Brain changes to acupuncture
Description
The effects of pain on the brain
Time Frame
3 visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician At least 4/10 clinical pain on the 10-point LBP intensity scale on average during the past two weeks prior to enrollment 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 Must have had a prior evaluation of their low back pain by a health care provider, which may include radiographic studies. Documentation of this evaluation will be obtained from the subject's medical record Exclusion Criteria: Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections) Radicular pain extending below the knee Complicated back problems (e.g., prior back surgery, medicolegal issues) Possible contraindications for acupuncture (e.g., coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis) Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator and/or a T score > 60 on the psychological measures assessed during Session 1) Prior acupuncture treatment for back pain; 1 year minimum wait for any condition other condition. Active substance abuse disorder in the past two years, as determined by subject self-report. The intent to undergo surgery during the time of involvement in the study. 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 MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy. Unresolved legal/disability/workers compensation claims in connection with low back. Instability of pain ratings in Session 2 or Session 3. Use of more than 60 mg prescription opioids or steroids for pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert R Edwards, Ph.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH - Martinos Center
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

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Brain Imaging Study of Acupuncture in Chronic Low Back Pain

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