Acute neck pain
Conditions
Interventions
Trade Name: Ibux
Product Code: Ibuprofen
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Akershus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of days, intensity and duration of neck pain, number of days and severity of bothersome neck, are assessed at baseline and daily for 14 days (except for pain intensity which is primary end-point), and at baseline to follow-up time-points 1, 4, 8, 12 and 24 weeks post-treatment (except pain duration in the follow-up period). Proportion with absolute reduction of =50%, =75% and 100% in days, intensity and duration with neck pain, and days and severity of bothersome neck from baseline and daily for 14 days, and at follow-up time-points 1, 4, 8, 12 and 24 weeks post-treatment (except pain duration in the follow-up period). RAND-12 and Neck Disability Index from baseline to day 14 and follow-up weeks 12- and 24.;Timepoint(s) of evaluation of this end point: Baseline, daily for 2 weeks, at 2 weeks, 3 and 6 months. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effecacy (reduction in pain intensity) of chiropractic and ibuprofen for acute neck pain Participants are allocated to one of four treatment groups i.e., chiropractic (1), sham chiropractic (2), ibuprofen (3) and placebo medication (4). Pain intensity is defined to be primary end-point. 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. ;Secondary Objective: Number of days, intensity and duration of neck pain, number of days and severity of bothersome neck, are assessed at baseline and daily for 14 days (except for pain intensity which is primary end-point), and at baseline to follow-up time-points 1, 4, 8, 12 and 24 weeks post-treatment (except pain duration in the follow-up period). Proportion with absolute reduction of =50%, =75% and 100% in days, intensity and duration with neck pain, and days and severity of bothersome neck from baseline and daily for 14 days, and at follow-up time-points 1, 4, 8, 12 and 24 weeks post-treatment (except pain duration in the follow-up period). RAND-12 and Neck Disability Index from baseline to day 14 and follow-up weeks 12- and 24.;Primary end point(s): Participants are allocated to one of four treatment groups i.e., chiropractic (1), sham chiropractic (2), ibuprofen (3) and placebo medication (4). Pain intensity is defined to be primary end-point. 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. ;Timepoint(s) of evaluation of this end point: Baseline, daily for 2 weeks, at 2 weeks, 3 and 6 months. | — |
Countries
Norway
Contacts
Public ContactHead and Neck Research Group
Akershus University Hospital
Outcome results
None listed