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

• ClinicalTrials.gov Identifier: NCT03867604
• Recruitment Status: Unknown
• First Posted: March 8, 2019
• Last Update Posted: March 8, 2019
• Sponsor: Taipei Medical University WanFang Hospital
• Information provided by (Responsible Party): Taipei Medical University WanFang Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myofascial Pain Syndrome	Procedure: Sham injection; Procedure: Fascia injection	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle: A Pilot Study
• Estimated Study Start Date: March 17, 2019
• Estimated Primary Completion Date: June 1, 2019
• Estimated Study Completion Date: December 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Upper back or shoulder pain [ Time Frame: Change from baseline VAS at 1 week ]
   visual analogue scale(VAS), range 0-10, the higher the worse pain
2. Upper back or shoulder pain [ Time Frame: Change from baseline VAS at 4 week ]
   visual analogue scale(VAS), range 0-10, the higher the worse pain
3. Upper back or shoulder pain [ Time Frame: Change from baseline VAS at 12 week ]
   visual analogue scale(VAS), range 0-10, the higher the worse pain

Secondary Outcome Measures :

1. Function [ Time Frame: Change from baseline SPADI at 1 week ]
   Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
2. Function [ Time Frame: Change from baseline SPADI at 4 week ]
   Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
3. Function [ Time Frame: Change from baseline SPADI at 12 week ]
   Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Yu-Hsuan Cheng, MS; +886 229307930 ext 1600; heathcyh@gmail.com

Sponsors and Collaborators

Taipei Medical University WanFang Hospital

Investigators

• Study Director: Yu-Hsuan Cheng, Cheng; Taipei Medical University, Taiwan, R.O.C.

More Information

• Responsible Party: Taipei Medical University WanFang Hospital
• ClinicalTrials.gov Identifier: NCT03867604
• Other Study ID Numbers: N201811013
• First Posted: March 8, 2019
• Last Update Posted: March 8, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders; Disease; Pathologic Processes; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases