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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT04459104
Eligibility Criteria:
GROUP 1=Chronic Low Back Pain
Inclusion Criteria
* Women between 18 and 65 years old;
* Native Dutch speaker;
* Experiencing chronic nonspecific low back pain (i.e. pain present for at least 3 months, at least 3 days per week);
* No new medication or new treatments started in the 6 weeks prior to or during study participation;
* Non-specific failed back surgery can be included if the operation was anatomically successful and happened at least 3 years ago;
* No physical exertions over 3 Metabolic Equivalent of Task (MET) in the 3 days before the assessments;
* No analgesics/ caffeine/ alcohol/ nicotine 48 hours prior to the assessments
Exclusion Criteria
* People who have any other diagnosed systemic diseases e.g. diabetes mellitus, hypertension, cardiovascular diseases etc;
* Participants who have neuropathic pain according to "Douleur Neuropathique 4 Questionnaire" and the S-LANSS Neuropathic Pain Score;
* Chronic widespread pain diagnosis (like fibromyalgia, chronic fatigue syndrome, whiplash);
* Current pregnancy or pregnant in the past year;
* Specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)
GROUP 2= Breast Cancer Survivors
Inclusion Criteria
* Female breast cancer survivors with chronic pain (lasting at least 3 months, at least 3 days per week);
* Participants between 18 and 65 years old;
* Native Dutch speaker;
* Active treatment ended at least 3 months ago (i.e. surgery, radiotherapy and chemotherapy; hormone and immune therapy can be going on);
* No analgesics/ caffeine/ alcohol/ nicotine 48 hours prior to the assessments
Exclusion Criteria
* People who have any other systemic disease like hypertension, Type II Diabetes etc;
* Current pregnancy or pregnant in the past year;
* Current active cancer process;
* Tube feeding
GROUP 3= Healthy, Pain-Free Controls
Inclusion Criteria
* Female, healthy and pain-free participants between 18 and 65 years old;
* Native Dutch speaker;
* No analgesics/ caffeine/ alcohol/ nicotine 48 hours prior to the assessments
Exclusion Criteria
* Current pregnancy or pregnant in the past year;
* People who have any other diagnosed systemic diseases e.g. diabetes mellitus, hypertension, cardiovascular diseases;
* Participants who have neuropathic pain according to "Douleur Neuropathique 4 Questionnaire" and the S-LANSS Neuropathic Pain Score;
* Chronic widespread pain diagnosis (like fibromyalgia, chronic fatigue syndrome, whiplash);
* Specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04459104
Study Brief:
Protocol Section:
NCT04459104