About the project
The project is a clinical placebo randomized controlled trial with four treatment groups: one group receives chiropractic manipulation treatment, one group receives sham chiropractic manipulation treatment, one group receives Ibuprofen and one group receives placebo medicine.
Manual treatment involves five chiropractic treatments over 10-12 days of approx. 15 minutes duration. Pharmacological treatment involves three doses of Ibuprofen/placebo medicine daily for 12 days (as a course of treatment).
Electronic questionnaires via Nettskjema will be used at baseline, during treatment for 14 days, and at five different time points, 1-, 4-, 8-, 12- and 24 weeks after the end of treatment. Data will be stored and kept at the services for Sensitive Data (TSD), at the University of Oslo.
The primary endpoint will assess the difference in average pain intensity from baseline to day-14 on a pain scale (Numerical Rating Scale). Chiropractic manipulation treatment will be compared with chiropractic sham manipulation treatment, ibuprofen and placebo medicine, respectively.
Ibuprofen is compared with placebo medicine as a secondary endpoint. Other secondary endpoints assess average pain intensity and duration at different time points, as well as documenting side effects, the degree to which blinding is successful and treatment satisfaction.
Outcomes
This study will examine the effect of chiropractic manipulation treatment for patients with acute neck pain. To our knowledge, this is the largest, and first clinical study to include four treatment groups and two control groups.
Background
Neck pain is a leading cause of non-fatal disability in adults worldwide, with an estimated prevalence of 4.9 percent, which corresponds to ≥260,000 Norwegians experiencing neck pain on any given day.
Musculoskeletal disorders in Norway exceeds NOK 500 million per day and NOK 185 billion per year in direct and indirect costs.
Chiropractic manipulation treatment and non-steroidal anti-inflammatory drugs such as Ibuprofen are commonly used despite a lack of compelling efficacy data.
Link to further information on background regarding the study
Chaibi, A., et al. (2021). Spinal Manipulative Therapy for Acute Neck Pain: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. J Clin Med 10(21). Spinal Manipulative Therapy for Acute Neck Pain: A Systematic Review and Meta-Analysis of Randomised Controlled Trials - PubMed (nih.gov)
Trial registration
ClinicalTrials.gov identifier: NCT05374057
EU Clinical Trials Register: EudraCT number: 2021-005483-21
Financing
- Stiftelsen DAM via The Norwegian Spine and Back Pain Association
Cooperation
- Oslo Univesity
- Akershus University Hospital
- The Norwegian Spine and Back Pain Association
Project start - finish
September 2021 – August 2024