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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07395102
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants aged ≥ 18 years
* Participants experiencing low back pain for at least 3 months (\>12 weeks)
* Highest low back pain intensity within the past 2 weeks with a score of ≥ 3 on a 0-10 Numeric Pain Rating Scale (NPRS)
* Receiving pharmacological therapy with a stable analgesic regimen for at least 2 weeks prior to enrollment
* Presence of physical functional disability as indicated by an Oswestry Disability Index (ODI) score \> 20%
* Willing and able to participate in the study until completion and to provide written informed consent
Exclusion Criteria:
* History of hypersensitivity reactions to acupuncture or thread embedding acupuncture, or known allergy to stainless steel or polydioxanone (PDO) threads
* History of keloid formation
* Presence of scars (cicatrices) or skin disorders at the thread embedding acupuncture insertion sites in the lower back area
* Specific spinal pathology including fracture, tumor, infection, or severe lumbar spinal stenosis requiring surgical intervention
* Structural spinal abnormalities (scoliosis or kyphosis) detected on physical examination
* History of spinal surgery or indication for spinal surgery due to severe neurological deficits
* Presence of cardiac disease, hematological disorders, or uncontrolled diabetes mellitus
* Regular use of systemic steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, anticoagulants, or topical analgesic medications
* Receipt of other treatments for low back pain, including dry needling, neuromuscular taping, spinal injections, or acupuncture within the past 2 weeks, or thread embedding acupuncture within the past 6 months
* Severe cognitive impairment, severe psychiatric or psychological disorders, or history of alcohol or substance abuse
* Pregnant or breastfeeding women, or women planning pregnancy within the next 6 months
* Body mass index (BMI) \< 18 kg/m²
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07395102
Study Brief:
Protocol Section:
NCT07395102