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Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain
This study is currently recruiting participants.
Verified April 2016 by Robert Edwards, Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Collaborators:
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Robert Edwards, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01595451
First received: May 8, 2012
Last updated: April 20, 2016
Last verified: April 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Chronic Low Back Pain Low Back Pain Back Pain | Procedure: Acupuncture |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain |
Resource links provided by NLM:
Further study details as provided by Robert Edwards, Brigham and Women's Hospital:
Primary Outcome Measures:
- Pain improvement in patients with lower back pain [ Time Frame: 6 week study ]Acupuncture in patients with lower back pain
| Estimated Enrollment: | 88 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Traditional Acupuncture
Acupuncture will be delivered to 12 points traditionally used to treat chronic low back pain.
|
Procedure: Acupuncture
A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
|
|
Placebo Comparator: Non-traditional Acupuncture
You will receive non-traditional acupuncture at 12 points for chronic low back pain.
|
Procedure: Acupuncture
A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595451
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595451
Contacts
| Contact: Ana Ortiz, BA | 617-726-0324 | AKOrtiz@partners.org |
Locations
| United States, Massachusetts | |
| MGH - Martinos Center | Recruiting |
| Charlestown, Massachusetts, United States, 02129 | |
| Contact: Ana Ortiz, BA 617-726-0324 AKOrtiz@Partners.org | |
| Principal Investigator: Robert Edwards, Ph.D. | |
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
| Principal Investigator: | Robert Edwards, Ph.D. | Brigham and Women's Hospital |
More Information
| Responsible Party: | Robert Edwards, Principal Investigator, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01595451 History of Changes |
| Other Study ID Numbers: |
2011P000757 |
| Study First Received: | May 8, 2012 |
| Last Updated: | April 20, 2016 |
Keywords provided by Robert Edwards, Brigham and Women's Hospital:
|
Acupuncture Back Pain Lower Back Pain |
Brigham and Women's Hospital Massachusetts General Hospital Effects of Acupuncture |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on August 16, 2017