Investigation of the effects of chiropractic spinal manipulative therapy and medicine on acute neck pai

Phase 1

Conditions: Acute neck pain
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2021-005483-21-NO

Lead Sponsor: Akershus University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

Inclusion Criteria

Eligible participants are between 18 and 59 years of age who present to the primary care chiropractic clinic with acute non-specific and 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, with onset of the present episode =2 weeks prior to the 1st chiropractic visit, and with moderate, severe or very severe pain intensity, i.e., =4, on a numeric rating scale (NRS) 0-10. In order to capture patients with episodic neck pain, they should have been pain free for at least four consecutive weeks prior to the present pain episode and in order to make it possible to perform a successful sham intervention, they should not have been treated by a chiropractor during the past 12 months. Participants will accept not to seek other manual and/or pharmacological treatments for their acute neck pain during the intervention period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Contraindication to ibuprofen (active ulcer pepticum, gastrointestinal bleeding, previous repeated episode (=2 detected events) with ulcer pepticum or gastrointestinal bleeding, previous gastrointestinal bleeding or ulcer using NSAIDs, hypersensitivity to ibuprofen, asthma induced by acetylsalicylic acid or other NSAIDs, urticaria or rhinitis, severe heart failure (NYHA grade IV) and/or renal failure (glomerulus infusion <30 ml/min)), contraindication to SMT, pregnancy, signs of spinal radiculopathy including progressive neurological deficit, concomitant low back pain with moderate, severe or very severe pain intensity (i.e., =4 on a NRS), major psychiatric disorders, rheumatoid arthritis, upper cervical spine instability (Sharp-Purser test), fracture in cervical and/or thoracic spine, previous cervical spine surgery, recent (<6 months) severe physical trauma to the head, neck or thoracic spine, recent (<2 weeks), any presence of ischemic symptoms upon examination including Horner’s syndrome, medical history of arterial anomalies, history of connective tissue disorder, familiar history of cervical artery dissection or other vascular disorders.