Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle

Myofascial Pain Syndrome Clinical Trial

Official title:

Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867604
• Other study ID #: N201811013
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2019
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Sham injection
Injection to the subcutaneous layer at upper trapezium level
• Fascia injection
Injection to the fascia below upper trapezium muscle

Locations

Country	Name	City	State
Taiwan	Taipei medical university	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper back or shoulder pain	visual analogue scale(VAS), range 0-10, the higher the worse pain	Change from baseline VAS at 1 week
Primary	Upper back or shoulder pain	visual analogue scale(VAS), range 0-10, the higher the worse pain	Change from baseline VAS at 4 week
Primary	Upper back or shoulder pain	visual analogue scale(VAS), range 0-10, the higher the worse pain	Change from baseline VAS at 12 week
Secondary	Function	Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse	Change from baseline SPADI at 1 week
Secondary	Function	Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse	Change from baseline SPADI at 4 week
Secondary	Function	Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse	Change from baseline SPADI at 12 week