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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT04129450
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
* A score ≥ 3 on the Pain, Enjoyment of Life and General Activity (PEG)
* Willing and able to provide online or telephone informed consent
* Speak English as the intervention manual is currently written in English
Exclusion Criteria:
* Do not meet the above inclusion criteria
* Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
* Pregnancy
* Metastatic cancer
* First-degree relatives (parents, siblings, child) of someone who has participated or is participating in the OPTIMUM study
* Members of the same household
* Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 12 or more months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04129450
Study Brief:
Protocol Section:
NCT04129450