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 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT03437967
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older.
* Taking prescribed opioid pain medications in an amount in excess of 30 Morphine Equivalent Dose (MED) for 6 months or longer.
* Have been recommended to wean or reduce their MED.
* Medically stable such that subject does not have unstable angina, COPD requiring supplemental oxygen, untreated or active cancer or similar conditions that would make participation difficult or unsafe.
* Compliant with all physician recommendations relating to medication usage.
* Ambulatory and able to use the toilet independently.
* Negative pregnancy test in subjects of childbearing potential
* Willing to attempt opioid pain medication taper.
* Competent to provide informed consent.
* Capable of understanding and completing study questionnaires.
* Subject willing to participate in the study for up to 12 weeks.
Exclusion Criteria:
* Not capable of understanding or completing study questionnaires.
* Lacking capacity to provide fully informed consent.
* Substance use disorder not in remission.
* Considering surgery or other invasive procedures that would take place during the study.
* Used isotretinoin (Accutane) within 6 months prior to study enrollment
* Cancer not in remission.
* Need of ongoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy, massage therapy, chiropractic care or other treatments intended to remediate pain other than treatment in the Sharp Pain Program.
* A female who is pregnant or lactating, or of childbearing potential unless a medically acceptable method of birth control is in use.
* Any use of light-activated drugs (photodynamic therapy) or heat sensitive medications within 30 days of first treatment.
* Used an investigational drug/device therapy or participated in any clinical investigation relating to pain within 4 weeks prior to study enrollment.
* A psychiatric or psychological condition that would place undo stress on the subject, prevent full participation or compromise data collection.
* The subject is otherwise determined, based on the opinion of the Investigator, to be an unsuitable candidate for enrollment in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03437967
Study Brief:
Protocol Section:
NCT03437967