Back Pain Response to Different Acupuncture Methods

Lower Back Pain Clinical Trial

— LBP  

Official title:

Brain Plasticity Underlying Back Pain Response to Different Acupuncture Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598974
• Other study ID #: 2011P001364
• Status: Completed
• Phase: N/A
• First received: May 11, 2012
• Last updated: November 27, 2017
• Start date: January 2012
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: October 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

Procedure:
• Traditional Acupuncture

• Laser Acupuncture

Locations

Country	Name	City	State
United States	MGH - Martinos Center	Charlestown	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Massachusetts General Hospital, National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain improvement in patients with lower back pain	Pain rating changes for chronic low back pain after acupuncture sessions.	6 weeks