Clinical trial NCT04998630: Comparison of Focused ESWT by Frequency for Patients With Myofascial Pain Syndrome
Official title: Comparison of Focused ESWT by Low and High Frequency for Patients With Myofascial Pain Syndrome: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: ESWT
myofascial pain syndrome
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety according to the frequency of focused ESWT in patients with myofascial pain syndrome.

Detailed description: Myofascial pain syndrome is one of the common causes of musculoskeletal pain seen in clinical practice and is characterized by the presence of trigger points associated with sensitive areas such as taut bands of skeletal muscle. It may also be accompanied by referred pain, which is pain in other parts of the body. Although the pathophysiology and etiology of myofascial pain syndrome and trigger points are still unknown, there are reports that myofascial pain is a complex form of neuromuscular dysfunction caused by motor and sensory abnormalities involving both the peripheral nervous system and the central nervous system. Recently, it has been considered as a method of treatment for myofascial pain syndrome. In addition, although pain reduction and functional improvement of focused ESWT in patients with myofascial pain syndrome have been reported, related studies are lacking on the effect of focused ESWT according to the frequency difference. The purpose of the study is to examine the efficacy and safety of focused type ESWT frequency in patients with myofascial pain syndrome.

Eligibility criteria: Inclusion Criteria:

1. Those diagnosed with myofascial pain syndrome according to Simon's criteria
2. Pain is 4 points or more on the Numerical Rating Scale (NRS)

Exclusion Criteria:

1. Pain is due to trauma, fibromyalgia and neurological disorders including neuromyopathy, myelopathy, and stroke
2. If you have received injection treatment for trigger points within the last 2 months or have had surgery on the painful area within 1 year
3. If there is a high risk of bleeding due to severe coagulopathy, etc. or if you have recently had severe bleeding (except taking antiplatelet)
4. If you have a tumor, infection, kidney failure, severe liver disease, epilepsy, skin disease, or mental retardation

Primary outcomes:
measure: Change from baseline NRS (numerical rating scale) at each time frame
timeFrame: baseline, immediately after primary treatment, 1 day after primary treatment, 3 day after primary treatment, immediately after secondary treatment, 1 day after secondary treatment, 3 day after secondary treatment
Secondary outcomes:
measure: Number of treatment-related adverse events as assessed by CTCAE v4.0 at each time frame
timeFrame: immediately after primary treatment, 1 day after primary treatment, 3 day after primary treatment, immediately after secondary treatment, 1 day after secondary treatment, 3 day after secondary treatment
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang CHA Medical Center
state: Gyeonggi-do
Study officials:
affiliation: Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
name: Kyunghoon Min, MD, PhD
role: STUDY_DIRECTOR
References: