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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04520334
Eligibility Criteria:
General inclusion criteria:
* Low back pain and/or leg pain (caused by lumbar disorder) with at least 3 months duration.
* Pain intensity in lumbar spine and/or leg (caused by lumbar disorder) at least 30 on a 0-100 Visual Analogue Scale (VAS), being "the best description of pain the past 2 weeks". (As enrolment initially went slow, also patients scoring VAS pain intensity 25 to 30 became eligible if their pain situations were qualitatively assessed severe, resulting in enrolment of 5 such patients).
* Resident in the county of Skåne (southern part of Sweden).
* Comfortable with the Swedish language.
* Acceptance not to practise Yoga, Meditation, or any other Qigong exercises during or 1 month after the intervention.
Specific inclusion criteria, clinical pathway:
* Postoperative after lumbar spine surgery: one lumbar spine surgery 1-6 years earlier, for either spinal stenosis, spondylolisthesis, or segmental pain. Pain intensity (back and/or leg) at least 30 on 0-100 mm VAS in latest SweSpine follow-up protocol.
* Patients from Primary Healthcare Centres: chronic low back pain (at least 3 months duration) with or without leg pain.
* Patients on waiting list for lumbar spine surgery: Planned first surgery for either spinal stenosis, spondylolisthesis, or segmental pain.
Exclusion criteria:
* Lumbar spine or other major surgery planned before, during, or within 1 month after the intervention period.
* History of serious mental disease, epilepsy, or narcolepsy.
* Current abuse of medicament, drug, or alcohol.
* Pregnancy (due to practical reasons only).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04520334
Study Brief:
Protocol Section:
NCT04520334