Chiropractic Spinal Manipulative Therapy for Acute Neck Pain

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Acute neck is very common in the general population and often causes disability over shorter or longer time periods. Unfortunately, the efficacy of chiropractic spinal manipulative therapy (CSMT) and the efficacy of Non-steroidal Anti-inflammatory Drugs (NSAIDs) on acute neck pain is unknown. This 4-armed randomized controlled trial (RCT) will likely provide evidence for the efficacy of CSMT as well as NSAIDs. The applied methodology of the study will aim towards the highest research standards possible for manual-therapy RCTs, thus avoiding typical methodological shortcomings from previous manual-therapy studies. Our aim is to establish evidence-based knowledge on the efficacy of CSMT and NSAIDs in the treatment of acute neck pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Akershus
• Collaborators: The Dam Foundation; University of Oslo
• Treatments: Ibuprofen

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 6 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. Ingestion of NSAIDs

3. Prescription opioids within ≤14 days

4. Ingestion of any analgesics within ≤24 hours prior to baseline

5. On prescribed antidepressant

6. Major psychiatric disorder

7. Pregnancy or intention to be pregnant

8. Contraindication to SMT

9. Signs of spinal radiculopathy including progressive neurological deficit

10. Upper cervical spine instability (positive Sharp-Purser test)

11. Previous fracture in the cervical and/or thoracic spine

12. Previous cervical spine surgery

13. Recent (<6 months) severe physical trauma to the head, neck or thoracic spine within the previous 6 months

14. Concomitant low back pain with moderate, severe or very severe pain intensity (≥4 on a NRS)

15. Current chronic pain (defined as ≥3 months duration)

16. Rheumatoid arthritis

17. Recent (<2 weeks) acute respiratory infection with fever

18. Any presence of ischemic symptoms upon examination

19. Horner's syndrome

20. Medical history of arterial anomalies

21. History of connective tissue disorder

22. Familial history of cervical artery dissection

23. Other vascular disorders

24. Inability to understand instructions given in the Norwegian language

25. Inability to fill out digital questionnaires

26. Other reasons to exclude the patient as deemed necessary by the chiropractor