ClinicalTrials.gg
Sign In
CompletedNCT01595451Updated Nov 29, 2017

Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain

An interventional study of Acupuncture in Chronic Low Back Pain, Low Back Pain and Back Pain, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-11-29.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2012, registered May 2012).
Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

We are doing this study to investigate the effects 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 treatment. You will be randomly assigned to one of two groups to receive either real or placebo acupuncture.

Acupuncture has been used for many years to help relieve pain. However, it is not clear how acupuncture works. Acupuncture may relieve pain by changing activity in the nervous system. Some studies indicate that acupuncture may relieve the low back pain. However, we need more research to see how well acupuncture works to relieve pain for people with this condition.

In this study, we will measure your brain activity before and after you do exercises to make your back pain worse. We will also measure your brain activity while inflating a pressure cuff device on your lower leg. We will measure this brain activity using a research tool called functional MRI (fMRI). Functional MRI is a very fast MRI that uses radio waves and a magnet, and allows the study investigators to look at changes in blood flow to different parts of the brain when there are changes in brain activity.

02

Conditions studied

  • Chronic Low Back Pain
  • Low Back Pain
  • Back Pain

Keywords

  • Acupuncture
  • Back Pain
  • Lower Back Pain
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Effects of Acupuncture
03

In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's enrollment of 79 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Browse Brigham and Women's Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
  • Subjects must be able to provoke or exacerbate their cLBP using our calibrated exercise-like maneuver.
  • At least 4/10 clinical pain on the 11-point LBP severity 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.
  • Right handed individuals
  • 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 subject's medical record.

Exclusion criteria

Exclusion Criteria:

  • Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)
  • Complicated back problems (e.g., prior back surgery, medico-legal 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 treatment difficult (e.g., paralysis, psychoses, or other severe psychiatric problems based on the judgment of a physician investigator and/or a T score >60 on the psychological assessments performed during Session 1)
  • Prior acupuncture treatment for back pain; 1 year minimum for any other condition.
  • The intent to undergo surgery during the time of involvement in the study.
  • History of cardiac, respiratory, or nervous system disease that, in the judgment of a physician investigator, precludes participation in the study because of a heightened potential for adverse outcome (e.g., asthma, claustrophobia)
  • Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of closed spaces, pregnancy)
  • Active substance abuse disorders within the last 24 months, based on subject self-report
  • Unresolved medical legal/disability/workers compensation claims
  • Radicular knee pain extending below the knee
  • Use of more than 60 mg morphine equivalent prescription opioids or steroids for pain.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
79 participants (actual)

Study arms

  • Active comparator
    Traditional Acupuncture

    Acupuncture will be delivered to 12 points traditionally used to treat chronic low back pain.

    Procedure: Acupuncture

  • Placebo comparator
    Non-traditional Acupuncture

    You will receive non-traditional acupuncture at 12 points for chronic low back pain.

    Procedure: Acupuncture

Interventions

  • ProcedureAcupuncture

    A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.

06

What researchers measure

Primary outcomes

  1. Pain improvement in patients with lower back pain

    Acupuncture in patients with lower back pain

    Time frame: 6 week study

07

Study locations

1 site
  • MGH - Martinos Center
    Charlestown, Massachusetts 02129, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2012 to primary completion in May 2017, 64 months.

Of 1,187 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 64 months is above that.

Counting every sponsor, half of 1,246 studies reached it within 11 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2012
First posted
May 10, 2012
StartActual
Jan 2012
Primary completionActual
May 2017
CompletionActual
Oct 2017
Last update
Nov 29, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01595451
Lead sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Robert Edwards (Principal Investigator, Brigham and Women's Hospital) — Principal investigator
First posted
May 10, 2012
Start date
Jan 2012
Primary completion
May 2017
Completion
Oct 2017
Last update
Nov 29, 2017

Study contacts

Robert Edwards, Ph.D.
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Low Back Pain →

Other studies from this sponsor

Brigham and Women's Hospital →

Start the discussion