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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03664934
Eligibility Criteria:
Study population
The inclusion criteria for patients are:
* Chronic neck problems corresponding to WAD grades 2-3 verified by clinical examination
* Average estimated pain in the last week at least 20 mm on the visual analogue scale (VAS)
* Neck disability of more than 20% on the Neck Disability Index (NDI) \[10\]
* Working age (18 - 63 years)
* Daily access to a computer/tablet/smart phone and Internet
* Neck symptoms within the first week after the injury (i.e., neck pain, neck stiffness, or cervical radiculopathy).
For the present sub group study additional criteria were:
* Right handed
* Dominant right sided or equal sided pain
Inclusion criteria for healthy controls:
• Age and gender matched healthy individuals without neck pain and disability (VAS \<10mm, NDI \<5%) that feel overall healthy without known diseases.
Exclusion criteria for patients:
* Individuals with any of the following signs of head injury at the time of whiplash injury will be excluded: loss of consciousness, amnesia before or after the injury, altered mental status (e.g., confusion, disorientation), focal neurological changes (changes in smell and taste).
* Previous fractures or dislocation of the cervical spine
* Known or suspected serious physical pathology included myelopathy,
* Spinal tumours
* Spinal infection
* Ongoing malignancy
* Previous severe neck problems that resulted in sick leave for more than a month in the year before the current whiplash injury
* surgery in the cervical spine
* Generalized or more dominant pain elsewhere in the body
* Other illness/injury that may prevent full participation
* Inability to understand and write in Swedish
Additional criteria in the present sub group:
* Increased risk of bleeding,
* BMI \>35
* Contraindications of MRI such as metal, severe obesity, pacemaker and pregnancy.
Exclusion criteria for healthy controls:
* Earlier neck injury,
* Recurrent neck pain,
* Earlier treatment for neck pain.
* Increased risk of bleeding,
* BMI \>35
* Contraindications of MRI such as metal, severe obesity, pacemaker and pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
63 Years
Study:
NCT03664934
Study Brief:
Protocol Section:
NCT03664934