The Effectiveness of Osteopathic Treatment in Cervical Whiplash.

A controlled randomised clinical trial (RCT) was carried out between 13 January 2021 and 10 August 2022 at the Hospital San Juan de Dios del Aljarafe, in Bormujos (Seville, Spain), a regional hospital covering a population of 300,000.

The main objective of the study was to determine whether the intervention proposed resulted in an improvement, in terms of pain, mobility and quality of life, compared with the local conventional treatment. The secondary objectives were to determine the decrease in medication and number of pain sites, as well as the influence of age and sex on the findings.

Patients were randomised to the control and intervention groups using the "Quickcalcs" program. The study was blinded: patients were unaware of the group to which they had been assigned. Patient evaluations at the start and end were performed by a physiotherapist different to the one performing the intervention, who was also unaware of the patient assignment. The same person performed all therapies for both the control and intervention groups and was unaware of the pre-intervention measurements. The statistician who analysed the data was also unaware of the group to which each patient belonged.

The inclusion criteria were: patients diagnosed with WAD grade II (Quebec classification), aged between 18 and 55 years, who started physiotherapy treatment less than 10 days prior to joining the trial, and who agreed to join the trial and provided informed consent. Patients with a history of neck pain in the previous three months (other than the whiplash), or with a prior history of WAD, or who had previously received osteopathic treatment for WAD, were excluded. Pregnant women, patients suspected to be simulating or exaggerating their symptoms for financial reasons, and those who presented difficulties carrying out the evaluation correctly due to their culture or a language barrier, were also excluded. Patients with a history of chest, head or upper limb surgery, those diagnosed with a neurological condition (such as congenital or diabetic polyneuritis, or any neurological condition), rheumatic alterations (such as osteoarthritis, arthritis, ankylosing spondylitis, etc.), malformations or surgical interventions that prevented correct conduct of the evaluation test and/or contraindications for the application of osteopathic and/or conventional treatment, were also excluded.

The sample size was calculated using the GRANMO calculator required for the main dependent variables, namely pain (visual analogue scale (VAS)) and quality of life (Whiplash Disability Questionnaire (WDQ)18 and Neck Disability Index (NDI))19. The highest of the three sample sizes calculated (that for WAD) was used, with 46 subjects being required in each group to detect a difference of 20 units or more, accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided comparison and assuming a common standard deviation of 25, a correlation coefficient between the initial and final measurement of 0.16 and a loss to follow-up of 10%.