- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03867604
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yu-Hsuan Cheng, MS
- Phone Number: 1600 +886 229307930
- Email: heathcyh@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 116
- Taipei Medical University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham injection
Subcutaneous injection at upper trapezium muscle level
|
Injection to the subcutaneous layer at upper trapezium level
|
Experimental: Fascia injection
Fascia injection, below upper trapezium muscle
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Injection to the fascia below upper trapezium muscle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline VAS at 1 week
|
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
|
Change from baseline VAS at 4 week
|
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
|
Change from baseline VAS at 12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Function
Time Frame: Change from baseline SPADI at 1 week
|
Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
|
Change from baseline SPADI at 1 week
|
Function
Time Frame: Change from baseline SPADI at 4 week
|
Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
|
Change from baseline SPADI at 4 week
|
Function
Time Frame: Change from baseline SPADI at 12 week
|
Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
|
Change from baseline SPADI at 12 week
|
Collaborators and Investigators
Investigators
- Study Director: Yu-Hsuan Cheng, Cheng, Taipei Medical University, Taiwan, R.O.C.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201811013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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