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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT05321550
Eligibility Criteria:
Inclusion Criteria Fibromyalgia patients:
\- diagnosed according to 2010 ACR-criteria
Inclusion Criteria neck pain patients:
\- having idiopathic neck pain complaints or having grade 1 (pain, stiffness or tenderness of the neck and without objective physical abnormalities) or grade 2 (neck complaints and musculoskeletal disorders such as decreased range of motion and tender pain points) according to the Quebec Task Force on Whiplash Associated Disorders
Inclusion Criteria low back pain patients:
\- having idiopathic low back pain complaints
Inclusion Criteria healthy controls:
* no history of serious pain complaints (e.g. severe migraine, fibromyalgia, etc.)
* no low back or neck pain complaints with an intensity of ≥2/10 on a visual analogue scale in the past year and of such severity that the daily activities were disrupted and a (para)medic was consulted
Exclusion Criteria:
* history of severe respiratory (e.g. cystic fibrosis), orthopedic (e.g. whiplash trauma), neurological (e.g. cerebrovascular incident), cardiovascular (e.g. severe hypertension), or endocrinological (e.g. diabetes) disorders
* recent psychological trauma (e.g. post-traumatic stress disorder)
* history of spinal surgery (e.g. lumbar discectomy), spinal trauma (e.g. vertebral fracture), or severe spinal deformities (e.g. spondylolisthesis)
* BMI ≥35 (due to potential difficulties in obtaining an NFR in severely overweight individuals)
* having pacemakers and defibrillators (absolute exclusion criteria for electrical stimulus stimulation, i.e. TENS)
* pregnancy, lactation, or within 1 year postpartum
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05321550
Study Brief:
Protocol Section:
NCT05321550