Authorised Therapeutic use (Phase IV) Acute neck pain

Chiropractic spinal manipulative therapy for acute neck pain: a 4-armed clinical placebo randomized controlled trial

EU CTIS ID: 2023-509624-17-00

What this study is testing

Investigate efficacy of CSMT and NSAIDs on the intensity of acute neck pain in the treatment period

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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 (35). 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.

You likely can't join if

  • 1. Contraindication to ibuprofen a. active peptic ulcer b. gastrointestinal bleeding c. previous repeated episode (≥2 detected events) with peptic ulcer or gastrointestinal bleeding d. previous gastrointestinal bleeding or ulcer using NSAIDs e. hypersensitivity to ibuprofen f. asthma induced by acetylsalicylic acid or other NSAIDs g. urticarial h. rhinitis i. severe heart failure (NYHA class IV) j. 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 questionnaire and are randomized at the clinic 3. On prescribed antidepressant. 4. Major psychiatric disorder. 5. Pregnancy or intension 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.