Back to resultsBack Pain Response to Different Acupuncture Methods (LBP)
Primary Purpose
Lower Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Acupuncture
Laser Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Lower Back Pain focused on measuring Lower Back Pain, Acupuncture
Eligibility Criteria
Inclusion Criteria:
- Volunteers 18-60 years of age.
- Meet the Classification Criteria of the 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 11-point LBP intensity scale.
- Patients must be able to provoke or exacerbate their chronic LBP using our calibrated exercise-like maneuver.
- Must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. Documentation of this evaluation will be sought from Partners or outside medical records and kept in the subject's research record.
- 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:
- Specific causes of back pain (e.g. cancer, fractures, spinal stenosis, infections),
- 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 acupuncture intervention effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
- Conditions making acupuncture difficult (e.g. paralysis, psychoses),
- Prior acupuncture treatment for back pain; 1 year wait for any other type.
- The intent to undergo surgery during the time of involvement in the study.
- History of cardiac, respiratory, or nervous system disease that, in Dr. Wasan'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.
- Involvement in workmen's compensation or disability claims.
- Radicular pain extending below the knee.
- Active substance abuse disorders within the last 24 months, based on subject self-report.
- 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 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Traditional Acupuncture
Laser Acupuncture
Wait-List
Arm Description
Participants will receive acupuncture over 6 30-minute sessions.
Participants will receive laser acupuncture over 6 30-minute sessions.
Subjects will be put on a 6 week wait-list and receive vouchers for acupuncture at a local clinic.
Outcomes
Primary Outcome Measures
Pain improvement in patients with lower back pain
Pain rating changes for chronic low back pain after acupuncture sessions.
Secondary Outcome Measures
Full Information
NCT ID
NCT01598974
First Posted
May 11, 2012
Last Updated
November 27, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01598974
Brief Title
Back Pain Response to Different Acupuncture Methods
Acronym
LBP
Official Title
Brain Plasticity Underlying Back Pain Response to Different Acupuncture Methods
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
Acupuncture has been used for many years to help relieve pain. However, it is not clear how acupuncture works. We are doing this study to learn about the effects of different forms 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
Lower Back Pain, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Acupuncture
Arm Type
Experimental
Arm Description
Participants will receive acupuncture over 6 30-minute sessions.
Arm Title
Laser Acupuncture
Arm Type
Experimental
Arm Description
Participants will receive laser acupuncture over 6 30-minute sessions.
Arm Title
Wait-List
Arm Type
No Intervention
Arm Description
Subjects will be put on a 6 week wait-list and receive vouchers for acupuncture at a local clinic.
Intervention Type
Procedure
Intervention Name(s)
Traditional Acupuncture
Intervention Type
Procedure
Intervention Name(s)
Laser Acupuncture
Primary Outcome Measure Information:
Title
Pain improvement in patients with lower back pain
Description
Pain rating changes for chronic low back pain after acupuncture sessions.
Time Frame
6 weeks
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:
Volunteers 18-60 years of age.
Meet the Classification Criteria of the 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 11-point LBP intensity scale.
Patients must be able to provoke or exacerbate their chronic LBP using our calibrated exercise-like maneuver.
Must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. Documentation of this evaluation will be sought from Partners or outside medical records and kept in the subject's research record.
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:
Specific causes of back pain (e.g. cancer, fractures, spinal stenosis, infections),
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 acupuncture intervention effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
Conditions making acupuncture difficult (e.g. paralysis, psychoses),
Prior acupuncture treatment for back pain; 1 year wait for any other type.
The intent to undergo surgery during the time of involvement in the study.
History of cardiac, respiratory, or nervous system disease that, in Dr. Wasan'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.
Involvement in workmen's compensation or disability claims.
Radicular pain extending below the knee.
Active substance abuse disorders within the last 24 months, based on subject self-report.
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 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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Back Pain Response to Different Acupuncture Methods
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