Study design and patient enrollment
This study was conducted as a prospective randomized controlled trial. All participants were informed about the study and their written informed consent was taken. It was registered prospectively at ClinicalTrials.gov (ref. NCT04790071) and conducted in accordance with the Helsinki Declaration. The study protocol was approved by the local ethical committee of the Biruni University, Turkey (2015-KAEK-43-20-12).
The participants in this study were patients aged 30–60 who were diagnosed with HSP and administered to the physical medicine and rehabilitation polyclinic of our hospital between May 2019 and June 2019. These participants had an active MTrP in the upper trapezius, subscapularis, supraspinatus, infraspinatus, teres minor, pectoralis major, and biceps brachii muscles. The diagnosis of HSP was made based on the patient’s history, physical examination findings, and magnetic resonance imaging techniques.15 The diagnosis of MTrP was made based on the criteria defined by David G. Simons.8 Initially, 46 patients were included in the study, but two patients refused to participate. Two other patients did not meet the inclusion criteria since they had used painkillers for shoulder pain one week ago. Throughout the study, two patients from each group could not complete the treatment process. Finally, the study was conducted with 38 patients. The flow chart of the study is illustrated in Figure 1. The patients were randomized into two groups: the conventional treatment group and the conventional treatment–DN combination group. The randomization sequence was created using Excel 2016 (Microsoft, Redmond, WA, USA) using block sizes of 2 and 4. Sample size was calculated using the study by Mendigutía-Gómez et al.12 in which pain intensity before and after treatment was equal to 7.0 (1.3) and 2.1 (1.6) in dry needling group and 7.0 (1.4) and 6.5 (1.5) in conventional group, and considering 80% of power and alpha of 0.05, as well as two-tailed difference in pain intensity before and after treatment in each group. As there was a possibility that some patients do not complete the study, 23 patients were included in each group.