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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT05374057
Eligibility Criteria:
Inclusion criteria
1. Eligible participants are between the age of 18 and 59 years old
2. Acute non-radicular neck pain, i.e., grade 1 or 2 according to the classification by the Bone and Joint Decade 2000-2010 Task Force on neck pain
3. Onset of the present episode ≤2 weeks prior to the 1st chiropractic visit
4. Moderate, severe or very severe pain intensity, i.e., ≥4, on a numeric rating scale (NRS) 0-10
5. Pain free for at least four consecutive weeks prior to the present pain episode
6. Not treated by a chiropractor during the past 3 months
7. Participants must accept not to seek other manual and/or pharmacological treatments for their acute neck pain during the intervention period
8. Non-pregnant women. Women in doubt shall have a negative fertility test before inclusion
Exclusion criteria
1. Contraindication to ibuprofen
1. active peptic ulcer
2. gastrointestinal bleeding
3. previous repeated episode (≥2 detected events) with peptic ulcer or gastrointestinal bleeding
4. previous gastrointestinal bleeding or ulcer using NSAIDs
5. hypersensitivity to ibuprofen
6. asthma induced by acetylsalicylic acid or other NSAIDs
7. urticarial
8. rhinitis
9. severe heart failure (NYHA class IV)
10. renal failure (glomerulus infusion \<30 ml/min)
2. Taken pain- and/or anti-inflammatory medicine during the past 24 hours? (Patients that have taken acute pain- and/or anti-inflammatory medicine, including ibuprofen, can be included if they come back after 24 hours without having taken the medicine where they then fill out questionnaires and are randomized at the clinic)
3. On prescribed antidepressant
4. Major psychiatric disorder
5. Pregnancy or intention to be pregnant
6. Contraindication to SMT
7. Signs of spinal radiculopathy including progressive neurological deficit
8. Upper cervical spine instability (positive Sharp-Purser test)
9. Previous fracture in the cervical and/or thoracic spine
10. Previous cervical spine surgery
11. Recent (\<6 months) severe physical trauma to the head, neck or thoracic spine within the previous 6 months
12. Concomitant low back pain with moderate, severe or very severe pain intensity (≥4 on a NRS)
13. Current chronic pain (defined as ≥3 months duration)
14. Rheumatoid arthritis
15. Recent (\<2 weeks) acute respiratory infection with fever
16. Any presence of ischemic symptoms upon examination
17. Horner's syndrome
18. Medical history of arterial anomalies
19. History of connective tissue disorder
20. Familial history of cervical artery dissection
21. Other vascular disorders
22. Inability to understand instructions given in the Norwegian language
23. Inability to fill out digital questionnaires
24. Other reasons to exclude the patient as deemed necessary by the chiropractor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT05374057
Study Brief:
Protocol Section:
NCT05374057