Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT01595451
Eligibility Criteria:
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:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01595451
Study Brief:
Protocol Section:
NCT01595451