Osteopathic treatment of patients with shoulder pain. A pragmatic randomized controlled trial

Background: Shoulder complaints are common in the general population. Typically, the diagnosis of a specific pathology is lacking. The objective of this trial was to evaluate the effectiveness of an osteopathic treatment in patients suffering from shoulder pain. Methods: A pragmatic randomized controlled trial was conducted in patients with a history of shoulder pain of 6 weeks to 12 months, and a pain intensity level of at least 40% on the visual analogue scale (VAS). Participants were identified from the general population in Germany and allocated by means of external randomization to an intervention group or a control group. Patients in the intervention group received five osteopathic treatments at intervals of two weeks. Treatment was custom tailored and based on osteopathic principles. Controls received their osteopathic treatment after an 8-week untreated waiting period. Primary outcome parameters were pain intensity and frequency, measured by VAS and Likert Scales. Secondary outcome parameters were shoulder specific pain and disability (Shoulder Pain and Disability Index, SPADI), and quality of life (SF-36). Results: A total of 70 patients aged 25e70 years (average age 45.6 +/- 13.4 years) were included, 36 in the intervention group and 34 in the control group. The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005). The proportion of participants with a low frequency of pain increased in the osteopathic group only (from 7 to 34 vs. 9 to 6 in the control group, p = 0.006), and the number of patients with a high frequency decreased in the osteopathic group only (from 29 to 2 vs. 25 to 28, p < 0.0005). Shoulder specific pain and disability also improved. The follow-up assessment in the intervention group showed further improvements. Conclusions: Five osteopathic treatments over a period of eight weeks led to statistically significant and clinically relevant positive changes of pain and disability in patients suffering from shoulder pain. (C) 2020 Elsevier Ltd. All rights reserved.