Chronic Low Back PainNCT01595451
Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain
A study testing Acupuncture in people with Chronic Low Back Pain and Low Back Pain, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain, Low Back Pain, Back Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH - Martinos Center
Charlestown, Massachusetts, 02129
About this study
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.
- Conditions
- Chronic Low Back Pain, Low Back Pain, Back Pain
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Back Pain, Lower Back Pain, Brigham and Women's Hospital, Massachusetts General Hospital, Effects of Acupuncture
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Acupuncture | Active comparator | Acupuncture will be delivered to 12 points traditionally used to treat chronic low back pain. Receives: Procedure: Acupuncture |
| Non-traditional Acupuncture | Placebo comparator | You will receive non-traditional acupuncture at 12 points for chronic low back pain. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain improvement in patients with lower back pain
Acupuncture in patients with lower back pain
Measured: 6 week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Robert Edwards, Brigham and Women's Hospital
- Investigators
- Robert Edwards, Ph.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595451
- Sponsor's protocol ID
- 2011P000757
- Status last verified
- Nov 2017
- First submitted
- 8 May 2012
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms of Acupuncture Treatment in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01595451
- Acronym / sponsor ID
- 2011P000757
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2012 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Acupuncture | Active comparator | Procedure: AcupunctureAcupuncture will be delivered to 12 points traditionally used to treat chronic low back pain. |
| Non-traditional Acupuncture | Placebo comparator | Procedure: AcupunctureYou will receive non-traditional acupuncture at 12 points for chronic low back pain. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureA licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions. | Procedure or surgery | Non-traditional Acupuncture, Traditional Acupuncture |
Primary outcome
Pain improvement in patients with lower back pain
Time frame: 6 week study
Acupuncture in patients with lower back pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Edwards, Ph.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Chronic Low Back Pain and Low Back Pain, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain improvement in patients with lower back pain (time frame: 6 week study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.