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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT04086667
Eligibility Criteria:
Inclusion Criteria:
To be enrolled in the study, the participant must fulfill the following:
* Informed written consent
* Have the ability to speak and read Danish.
* Between the age of 18 and 60.
* Body mass index \< 35
* LBP \> 3 months, defined as pain on the posterior aspect of the body between the 12th thoracic vertebrae and the gluteal folds.
* No previous back surgery and must not have had surgery in general in the last 4 months.
* Must not have received spinal manipulation in the last month.
* Must not take other pain medication than paracetamol, NSAIDs or weak synthetic opioids
* Not have radiculopathy: dermatomal leg pain and a positive straight-leg-raise test \<60 degrees.
* Not have problems regarding deep vein thrombosis, circulatory issues in the under extremity, compartment syndrome or severe lung diseases
* No competing diagnoses which could a) confound the diagnosis of NSLBP e.g. osteoporosis, cancer, fibromyalgia etc. b) interfere with the allocated treatment or c) interfere with QST and VT testing
Exclusion Criteria:
Participants will be excluded during the study if:
* Not completing the allocated intervention (minimum 75% of scheduled treatments).
* Receiving other treatment than that administered as part of the study
* Deviate from the agreed upon medication at baseline measures within the treatment period.
* Inability to hold breath for 10 seconds
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04086667
Study Brief:
Protocol Section:
NCT04086667