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:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT05463367
Eligibility Criteria:
Inclusion Criteria:
* History of low back pain for a minimum of 6 months daily (prior to screening), meeting the Quebec Task Force Classification System symptom categories I-III;
* Male or female, age equal or greater than 18 years, with no racial/ethnic restrictions;
* Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;
* Must be in generally stable health;
* Must sign an informed consent document after a complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits and potential risks, and are willing to participate;
* Must have, on average ≥ 4/10 units of pain intensity over the course of a 1-4 week period prior to the brain scanning visit;
* Must be willing to complete daily smartphone/computer eDiary ratings;
* Must be on regular opioid therapy or for at least 3 months prior to randomization which will be up to the clinical investigator's decision
* Must be on a short acting opioid therapy (anticipated duration of action \< 6 hours)
Exclusion Criteria:
* Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;
* Other comorbid chronic pain or neurological conditions;
* Use of therapeutic doses of antidepressant medications at unstable doses (i.e., tricyclic depressants, SSRIs, SNRIs; low doses used for sleep may be allowed);
* Significant other unstable medical disease such as diabetes, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy;
* Uncontrolled hypertension;
* Renal insufficiency;(correlated creatinine clearance \< 40mL/min or serum creatinine ≥2)
* Daily use of high doses of opioids,, as defined as \> 50mg morphine equivalent/day;
* Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
* In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
* Evidence of poor treatment compliance, in the judgment of the investigator;
* Intra-axial implants (e.g. spinal cord stimulators or pumps);
* All exclusion criteria for MR safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia;
* Pregnancy, or inability to use an effective form of contraception in women of child-bearing age;
* An established diagnosis of diabetes (type 1 or type 2)
* Lactose intolerance
* History of an allergic reaction to naproxen or any NSAID;
* History of any untoward reaction to carbidopa/levodopa
* Use of a patch or long acting opioid therapy (e.g. anticipated duration of action \> 6 hours)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05463367
Study Brief:
Protocol Section:
NCT05463367