IBUPROFEN for Acute neck pain | Neck pain

Inclusion criteria

• {"criterion_text":"- 1. Eligible participants are between the age of 18 and 59 years old\n- 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).\n- 3. Onset of the present episode ≤2 weeks prior to the 1st chiropractic visit.\n- 4. Moderate, severe or very severe pain intensity, i.e., ≥4, on a numeric rating scale (NRS) 0-10.\n- 5. Pain free for at least four consecutive weeks prior to the present pain episode.\n- 6. Not treated by a chiropractor during the past 3 months.\n- 7. Participants must accept not to seek other manual and/or pharmacological treatments for their acute neck pain during the intervention period.\n- 8. Non-pregnant women. Women in doubt shall have a negative fertility test before inclusion."}

Exclusion criteria

• {"criterion_text":"- 1. Contraindication to ibuprofen\n- a. active peptic ulcer\n- b. gastrointestinal bleeding\n- c. previous repeated episode (≥2 detected events) with peptic ulcer or gastrointestinal bleeding\n- d. previous gastrointestinal bleeding or ulcer using NSAIDs\n- e. hypersensitivity to ibuprofen\n- f. asthma induced by acetylsalicylic acid or other NSAIDs\n- g. urticarial\n- h. rhinitis\n- i. severe heart failure (NYHA class IV)\n- j. renal failure (glomerulus infusion <30 ml/min),\n- 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\n- 3. On prescribed antidepressant.\n- 4. Major psychiatric disorder.\n- 5. Pregnancy or intension to be pregnant\n- 6. Contraindication to SMT.\n- 7. Signs of spinal radiculopathy including progressive neurological deficit\n- 8. Upper cervical spine instability (positive Sharp-Purser test)\n- 9. Previous fracture in the cervical and/or thoracic spine\n- 10. Previous cervical spine surgery,\n- 11. Recent (<6 months) severe physical trauma to the head, neck or thoracic spine within the previous 6 months\n- 12. Concomitant low back pain with moderate, severe or very severe pain intensity (≥4 on a NRS)\n- 13. Current chronic pain (defined as ≥3 months duration)\n- 14. Rheumatoid arthritis\n- 15. Recent (<2 weeks) acute respiratory infection with fever\n- 16. Any presence of ischemic symptoms upon examination\n- 17. Horner’s syndrome\n- 18. Medical history of arterial anomalies\n- 19. History of connective tissue disorder\n- 20. Familial history of cervical artery dissection\n- 21. Other vascular disorders\n- 22. Inability to understand instructions given in the Norwegian language\n- 23. Inability to fill out digital questionnaires\n- 24. Other reasons to exclude the patient as deemed necessary by the chiropractor."}

Primary endpoints

• {"endpoint_text":"- Group 1) CSMT 2) CSMT sham manipulation 3) Ibuprofen medication 4) Placebo medication. The primary end-point will be defined as the mean pain intensity on a NRS 0-10. The primary analysis will assess the difference in mean pain intensity change from baseline to day 14 after baseline between group 1 and group 2, group 1 and group 3, and group 1 and group 4.","definition_or_measurement_approach":"Primary end-point defined as the mean pain intensity on a Numeric Rating Scale (NRS) 0-10. Primary analysis: difference in mean pain intensity change from baseline to day 14 between specified group comparisons (group 1 vs group 2, group 1 vs group 3, group 1 vs group 4)."}

Secondary endpoints

• {"endpoint_text":"- Group 1) CSMT 2) CSMT sham manipulation 3) Ibuprofen medication 4) Placebo medication. 1. Mean pain intensity (NRS 0-10) change from baseline to day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 in the treatment period, and from baseline to day 7, 28, 56, 84 and 168 post-treatment, respectively, and comparison between group 1 and group 2, group 1 and group 3, and group 1 and group 4, and group 3 and 4.\n- 2. Mean duration (hours) of neck pain change from baseline to day etc. See protocol for further details","definition_or_measurement_approach":"Mean pain intensity measured on NRS 0-10 at multiple timepoints (treatment days 2-13 and follow-up days 7, 28, 56, 84, 168). Secondary analyses compare group pairs as specified. Also mean duration (hours) of neck pain change from baseline; further details referenced in protocol."}

Norway

Earliest CTIS Part Ii Submission Date

27-02-2024

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

806

Number Of Participants

240

Primary sponsor

Full Name

Akershus University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"","full_name":"Stiftelsen Dam","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"University of Oslo","duties_or_roles":"Source of monetary support","organisation_type":""}