E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, daily for 2 weeks, at 2 weeks, 3 and 6 months. |
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E.5.2 | 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, daily for 2 weeks, at 2 weeks, 3 and 6 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Chiropractors arms are single blinded, pharmacological arms double-blinded |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Chiropractic spinal manipulative treatment and sham chiropractic |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 25 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS
Data will be collected electronically and sent securely to TSD, University of Oslo |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |