NCT01614639

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

5.3 years

First QC Date

May 23, 2012

Last Update Submit

November 27, 2017

Conditions

Low Back PainBack Pain Lower Back ChronicLow Back Pain, Recurrent

Keywords

AcupuncturefMRICLBPPainLow Back PainBack Pain

Outcome Measures

Primary Outcomes (1)

  • Brain changes to acupuncture

    The effects of pain on the brain

    3 visits

Study Arms (2)

Traditional Acupuncture

EXPERIMENTAL

Traditional Acupuncture given at 2 visits.

Procedure: Acupuncture

Electroacupuncture

EXPERIMENTAL

Electro-acupuncture given at 2 visits.

Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

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

ElectroacupunctureTraditional Acupuncture

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH - Martinos Center

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Low Back PainPainBack Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Robert R Edwards, Ph.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

May 23, 2012

First Posted

June 8, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2017

Study Completion

October 1, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

US(1)