Clinical trial NCT03867604: Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle
Official title: Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with myofascial pain syndrome at upper trapezius will be randomized into 2 groups, fascial injection group and subcutaneous control injection group. Pain condition pain, range of motion and function will be evaluated in 1 week, 4 weeks and 12 weeks after injection.

Detailed description: Myofascial pain syndrome(MPS) is characterized by a trigger point with a hyperirritable nodule and taut band of muscle or fascia. MPS was usually treated by dry needling or met needing, local anesthetics injection, to the trigger point. According to recent researches, dry and wet needling to affected muscle are effectiveness for short term and medium term pain relief. Although some researches indicated an increased viscosity at fascial layer in MPS and there are few studies of manipulation for fascial release. There is not study of injective fascial release.

Investigators will include 40 patients with myofascial pain syndrome at upper trapezius. Participants will be randomized into 2 groups, fascia injection group and subcutaneous control injection group. Investigators will use algometer to measure pain threshold and peak pressure, measure the range of motion of neck and shoulder and assess the neck and shoulder function by questionnaire. The examination will be done before injection, immediately after injection, 1 week, 4 weeks and 12 weeks after injection.

To our hypothesis, investigators suggest focal anesthetics injection could decrease the fascial viscosity and improved pain and quality of life.

Eligibility criteria: Inclusion Criteria:

* 20-70 years old
* diagnosed as a myofascial pain syndrome at upper trapezium muscle
* trigger point
* taut band
* refer pain while taut band irritation

Exclusion Criteria:

* Cognitive impairment.
* Post operation at neck and shoulder.
* Nerve compression at cervical region.
* Could not receive injection therapy, history of fainting during needling

Primary outcomes:
measure: Upper back or shoulder pain
timeFrame: Change from baseline VAS at 1 week
measure: Upper back or shoulder pain
timeFrame: Change from baseline VAS at 4 week
measure: Upper back or shoulder pain
timeFrame: Change from baseline VAS at 12 week
Secondary outcomes:
measure: Function
timeFrame: Change from baseline SPADI at 1 week
measure: Function
timeFrame: Change from baseline SPADI at 4 week
measure: Function
timeFrame: Change from baseline SPADI at 12 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei medical university
Study officials:
affiliation: Taipei Medical University, Taiwan, R.O.C.
name: Yu-Hsuan Cheng, Cheng
role: STUDY_DIRECTOR
References: