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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT04079894
Eligibility Criteria:
Inclusion Criteria for Patients with LSS:
* Informed written consent.
* Fluent in Danish in reading and speaking.
* Age \>60 with LSS, +/- spondylolisthesis diagnosed via clinical examination and MRI. Suffering from neurogenic claudication with positive answers to a set of six items characteristic to LSS\[29\].
* Patients in phase A will be included to represent a spectrum of severeness of LSS and age. Severeness will be evaluated by ODI score, VAS and self-reported maximum walking distance.
* Patients for phase C will have the additional inclusion criteria of being scheduled for decompressive surgery.
Exclusion Criteria:
* Other disease limiting walking rather than neurogenic claudication, such as cardiopulmonary diseases, vascular claudication, recent operation or fracture of spine, pelvis or leg, severe hip or knee arthrosis (not efficiently threated by hip/knee replacement), systemic muscular diseases, impaired vision.
* Traits which interfere with the participants' gait pattern, such as habitual use of walking aids during walking at home and away from home, drop foot.
Eligibility Criteria for Patients with LBP:
* Informed written consent.
* Fluent in Danish in reading and speaking.
* Age \>60
* Suffering from Low Back Pain
* Low Back Pain is the primary source of pain and disability.
Eligibility Criteria for Healthy Participants:
\- Healthy participants will be \>60 years old and have the same exclusion criteria as patients, with the addition of not suffering from neurogenic claudication.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04079894
Study Brief:
Protocol Section:
NCT04079894