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Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain, Low Back Pain, Back Pain

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 treatment trial for Chronic Low Back Pain focused on measuring Acupuncture, Back Pain, Lower Back Pain, Brigham and Women's Hospital, Massachusetts General Hospital, Effects of Acupuncture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
  • Subjects must be able to provoke or exacerbate their cLBP using our calibrated exercise-like maneuver.
  • At least 4/10 clinical pain on the 11-point LBP severity 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.
  • Right handed individuals
  • 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 subject's medical record.

Exclusion Criteria:

  • Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)
  • Complicated back problems (e.g., prior back surgery, medico-legal 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 treatment difficult (e.g., paralysis, psychoses, or other severe psychiatric problems based on the judgment of a physician investigator and/or a T score >60 on the psychological assessments performed during Session 1)
  • Prior acupuncture treatment for back pain; 1 year minimum for any other condition.
  • The intent to undergo surgery during the time of involvement in the study.
  • History of cardiac, respiratory, or nervous system disease that, in the judgment of a physician investigator, precludes participation in the study because of a heightened potential for adverse outcome (e.g., asthma, claustrophobia)
  • Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of closed spaces, pregnancy)
  • Active substance abuse disorders within the last 24 months, based on subject self-report
  • Unresolved medical legal/disability/workers compensation claims
  • Radicular knee pain extending below the knee
  • Use of more than 60 mg morphine equivalent prescription opioids or steroids for pain.

Sites / Locations

  • MGH - Martinos Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Traditional Acupuncture

Non-traditional Acupuncture

Arm Description

Acupuncture will be delivered to 12 points traditionally used to treat chronic low back pain.

You will receive non-traditional acupuncture at 12 points for chronic low back pain.

Outcomes

Primary Outcome Measures

Pain improvement in patients with lower back pain
Acupuncture in patients with lower back pain

Secondary Outcome Measures

Full Information

First Posted
May 8, 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
NCT01595451
Brief Title
Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain
Official Title
Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain
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 study to investigate the effects of acupuncture on chronic low back pain. We are interested in learning about brain activity during pain. We plan to look at brain activity at the beginning and the end of the study, after 6 sessions of acupuncture treatment. You will be randomly assigned to one of two groups to receive either real or placebo acupuncture. Acupuncture has been used for many years to help relieve pain. However, it is not clear how acupuncture works. Acupuncture may relieve pain by changing activity in the nervous system. Some studies indicate that acupuncture may relieve the low back pain. However, we need more research to see how well acupuncture works to relieve pain for people with this condition. In this study, we will measure your brain activity before and after you do exercises to make your back pain worse. We will also measure your brain activity while inflating a pressure cuff device on your lower leg. We will measure this brain activity using a research tool called functional MRI (fMRI). Functional MRI is a very fast MRI that uses radio waves and a magnet, and allows the study investigators to look at changes in blood flow to different parts of the brain when there are changes in brain activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Low Back Pain, Back Pain
Keywords
Acupuncture, Back Pain, Lower Back Pain, Brigham and Women's Hospital, Massachusetts General Hospital, Effects of Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Acupuncture
Arm Type
Active Comparator
Arm Description
Acupuncture will be delivered to 12 points traditionally used to treat chronic low back pain.
Arm Title
Non-traditional Acupuncture
Arm Type
Placebo Comparator
Arm Description
You will receive non-traditional acupuncture at 12 points for chronic low back pain.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
Primary Outcome Measure Information:
Title
Pain improvement in patients with lower back pain
Description
Acupuncture in patients with lower back pain
Time Frame
6 week study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months), as determined by the referring physician. Subjects must be able to provoke or exacerbate their cLBP using our calibrated exercise-like maneuver. At least 4/10 clinical pain on the 11-point LBP severity 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. Right handed individuals 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 subject's medical record. Exclusion Criteria: Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections) Complicated back problems (e.g., prior back surgery, medico-legal 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 treatment difficult (e.g., paralysis, psychoses, or other severe psychiatric problems based on the judgment of a physician investigator and/or a T score >60 on the psychological assessments performed during Session 1) Prior acupuncture treatment for back pain; 1 year minimum for any other condition. The intent to undergo surgery during the time of involvement in the study. History of cardiac, respiratory, or nervous system disease that, in the judgment of a physician investigator, precludes participation in the study because of a heightened potential for adverse outcome (e.g., asthma, claustrophobia) Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of closed spaces, pregnancy) Active substance abuse disorders within the last 24 months, based on subject self-report Unresolved medical legal/disability/workers compensation claims Radicular knee pain extending below the knee Use of more than 60 mg morphine equivalent prescription opioids or steroids for pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert 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 Mechanisms of Acupuncture Treatment in Chronic Low Back Pain

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