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

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

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome
• Intervention / Treatment: Procedure: Sham injection; Procedure: Fascia 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 116
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham injection; Subcutaneous injection at upper trapezium muscle level	Procedure: Sham injection; Injection to the subcutaneous layer at upper trapezium level
Experimental: Fascia injection; Fascia injection, below upper trapezium muscle	Procedure: Fascia injection; Injection to the fascia below upper trapezium muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper back or shoulder pain	visual analogue scale(VAS), range 0-10, the higher the worse pain	Change from baseline VAS at 1 week
Upper back or shoulder pain	visual analogue scale(VAS), range 0-10, the higher the worse pain	Change from baseline VAS at 4 week
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function	Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse	Change from baseline SPADI at 1 week
Function	Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse	Change from baseline SPADI at 4 week
Function	Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse	Change from baseline SPADI at 12 week

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Study Director: Yu-Hsuan Cheng, Cheng, Taipei Medical University, Taiwan, R.O.C.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes
• Other Study ID Numbers: N201811013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No