Back Pain Response to Different Acupuncture Methods

NCT01598974 | Completed DMC

• 1 other identifier: 2011P001364
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Back Pain

Keywords

Lower Back Pain; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Pain improvement in patients with lower back pain

  Pain rating changes for chronic low back pain after acupuncture sessions.

  6 weeks

Study Arms (3)

Traditional Acupuncture

EXPERIMENTAL

Participants will receive acupuncture over 6 30-minute sessions.

Procedure: Traditional Acupuncture

Laser Acupuncture

EXPERIMENTAL

Participants will receive laser acupuncture over 6 30-minute sessions.

Procedure: Laser Acupuncture

Wait-List

NO INTERVENTION

Subjects will be put on a 6 week wait-list and receive vouchers for acupuncture at a local clinic.

Interventions

Traditional Acupuncture PROCEDURE

Traditional Acupuncture

Laser Acupuncture PROCEDURE

Laser Acupuncture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts General Hospital: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

MGH - Martinos Center

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 15, 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)