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.