Brain Imaging Study of Acupuncture in Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

A Physiological fMRI Study of Acupuncture and Perceptions of Pain in Chronic Low Back Pain Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614639
• Other study ID #: 2011P000748
• Secondary ID: P01AT006663-01
• Status: Completed
• Phase: N/A
• First received: May 23, 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

We are doing this research study to learn about how acupuncture treatment works. This study is being done to look at changes in the brain, NOT to treat pain. We want to learn about brain activity during acupuncture. We will look at brain activity when a heating device touches the skin of a subject before and after the subject has acupuncture, to see what changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• 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:

• Meet the Classification Criteria of 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 10-point LBP intensity 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

• 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 the subject's medical record

Exclusion Criteria:

• Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)

• Radicular pain extending below the knee

• 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 treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis)

• Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator and/or a T score > 60 on the psychological measures assessed during Session 1)

• Prior acupuncture treatment for back pain; 1 year minimum wait for any condition other condition.

• Active substance abuse disorder in the past two years, as determined by subject self-report.

• The intent to undergo surgery during the time of involvement in the study.

• History of cardiac, respiratory, or nervous system disease that, in the investigator'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.

• Unresolved legal/disability/workers compensation claims in connection with low back.

• Instability of pain ratings in Session 2 or Session 3.

• Use of more than 60 mg prescription opioids or steroids for pain.

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Low Back Pain
• Low Back Pain, Recurrent

Intervention

Procedure:
• Acupuncture
A licensed acupuncturist will perform acupuncture for two 30 minute sessions.

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	Brain changes to acupuncture	The effects of pain on the brain	3 visits