Back Pain Response to Different Acupuncture Methods

Not Applicable

Completed

• Conditions: Lower Back Pain
• Interventions: Procedure: Traditional Acupuncture; Procedure: Laser Acupuncture

• Registration Number: NCT01598974
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2017-05
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Acupuncture	Traditional Acupuncture	Participants will receive acupuncture over 6 30-minute sessions.
Laser Acupuncture	Laser Acupuncture	Participants will receive laser acupuncture over 6 30-minute sessions.

Primary Outcome Measures

Name	Time	Method
Pain improvement in patients with lower back pain	6 weeks	Pain rating changes for chronic low back pain after acupuncture sessions.

Trial Locations

Locations (1)

MGH - Martinos Center; 🇺🇸 Charlestown, Massachusetts, United States