Myofascial pain syndrome (MPS) is one of the most common causes of musculoskeletal pain. Among patients with MPS, the upper trapezius muscle appears to be the common muscle that generates pain in the area of upper extremity. The main target treatment for MPS is to eradicate the painful trigger points by using treatment options, such as ultrasound, laser, and dry needling (DN). In the past decade, focused extracorporeal shockwave therapy (fESWT) has become the well-known treatment for pain relief in various musculoskeletal pain conditions. The main advantages of this non-invasive treatment modality are reducing pain, inflammation and promoting tissue healing. However, there were no previous studies compared effects of fESWT to dry needling. Therefore, the present study aims to compare the efficacy of the two treatments in terms of pain reduction and functional improvement.
* This study is a single-blinded non-inferiority randomized controlled trial that will compare the efficacy of fESWT to DN in terms of pain reduction and functional improvement in patients with MPS of the upper trapezius. * 58 patients will be recruited for the study and randomly allocated to 2 groups, mainly fESWT and DN. * For the fESWT group, the participants will receive fESWT once a week, for a total of 3 sessions, consecutively. While the participants in the DN group will receive DN at the painful trigger point for 1 session. Moreover, both groups will receive the same conservative treatment, for example, education, exercise, and behavioral modification advice. * The primary outcome is Visual Analogue Scale (VAS) and the secondary outcomes are Pain Pressure Threshold (PPT) and Neck Disability Index (NDI) which will be recorded at baseline, 1 week, 3 week, and 6 week from baseline. * Statistical analysis will be performed using Stata to detect statistically significant changes in the same group and differences between the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
53
fESWT will be done using an energy flux density of 0.20 - 0.25 millijoule (mJ)/mm2, a frequency of 4 Hz, and 1000 shocks per session which will be done one session per week, for a total of 3 sessions, consecutively.
DN will be done by using a sterile technique with a sterile acupuncture needle, a diameter of 0.25 mm, and a length of 30-40 mm. The needle will be applied to the painful active trigger point using fan-shaped movements and the fast-in and fast-out technique until the twitching response disappears.
Ramathibodi Hospital
Bangkok, Thailand
Visual Analogue Scale (VAS)
VAS is a subjective tool that is used to measure pain scores. In this study, the 100-numerical scale will be used, in which 0 means "no pain," whereas 100 means "the worst pain." Patients mark the scale to rate the pain score based on their pain perception.
Time frame: Changes in VAS were assessed at baseline, and at 4 and 6 weeks following baseline.
Pain pressure threshold (PPT)
PPT is used to assess the strength of a physical stimulus that causes pain. A mechanical pressure is applied over the measured area, such as a muscle. The minimum force that provokes pain is determined as the pain threshold.
Time frame: Changes in PPT were assessed at baseline, and at 4 and 6 weeks following baseline.
The Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a self-report questionnaire intended to evaluate patients' disabilities and how much their neck pain impacts their lives. This questionnaire consists of 10 items; 5 points for each item (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation).
Time frame: Changes in NDI were assessed at baseline and 6 weeks following baseline.
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