Skip to main content
OpenTrials
Completed

NCT Number: NCT01614639

Brain Imaging Study of Acupuncture in Chronic Low Back Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MGH - Martinos Center

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

A licensed acupuncturist will perform acupuncture for two 30 minute sessions.

Primary outcomes

  1. Brain changes to acupuncture

    Time frame: 3 visits

    The effects of pain on the brain

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Massachusetts General Hospital
  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2012
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.