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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT05820204
Eligibility Criteria:
Inclusion Criteria:
* Last-week average back pain of at least 4 of 10 at the two pretreatment timepoints (online pre-screening and informed consent session)
* Back pain that is an ongoing problem for at least half the days of the last 6 months
* Back pain that is worse than leg pain.
Exclusion Criteria:
* Current litigation or compensation associated with pain or plans to apply for compensation or engage in litigation in the next 6 months
* Active suicidal ideation with intent, recent history of suicide attempt, or recent history of suicide attempts or self-harm behaviors within the past 5 years (including non-suicidal self-harm)
* Recent history of inpatient psychiatric hospitalization within the past 5 years
* Active, current psychosis or mania
* Active, current substance abuse, or problems with substance abuse within the past 2 years
* Instability in living conditions or major interfering life events:
* Major surgery or other major medical event planned in coming six months
* Unsure whether will reliably have suitable conditions for telehealth appointments over the next two months, including a computer or tablet, reliable fast internet, and a quiet comfortable room that is reliably available.
* Major, interfering changes in employment or housing anticipated over the next six months
* Failure to complete at least 85% (6 of 7) of EMA surveys in the first week of the study (post-consent, pre-randomization)
* Leg pain worse than back pain
* Back surgery within the last 2 years
* Difficulty controlling bladder function (to screen out cauda equina syndrome)
* Serious medical illness (e.g., current, or recent cancer diagnosis, severe cardiovascular disease)
* Recent large unexplained, unintended weight loss (20lbs or more)
* Recent vertebral fracture/ known spinal fractures or tumors
* Known sensory/motor abnormalities in the trunk or legs.
* Self-reported diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, or polymyositis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05820204
Study Brief:
Protocol Section:
NCT05820204