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

Primary Purpose

Myofascial Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sham injection
Fascia injection
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Sham injection

    Fascia injection

    Arm Description

    Subcutaneous injection at upper trapezium muscle level

    Fascia injection, below upper trapezium muscle

    Outcomes

    Primary Outcome Measures

    Upper back or shoulder pain
    visual analogue scale(VAS), range 0-10, the higher the worse pain
    Upper back or shoulder pain
    visual analogue scale(VAS), range 0-10, the higher the worse pain
    Upper back or shoulder pain
    visual analogue scale(VAS), range 0-10, the higher the worse pain

    Secondary Outcome Measures

    Function
    Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
    Function
    Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
    Function
    Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse

    Full Information

    First Posted
    January 21, 2019
    Last Updated
    March 6, 2019
    Sponsor
    Taipei Medical University WanFang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03867604
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 17, 2019 (Anticipated)
    Primary Completion Date
    June 1, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University WanFang Hospital

    4. Oversight

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

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myofascial Pain Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sham injection
    Arm Type
    Sham Comparator
    Arm Description
    Subcutaneous injection at upper trapezium muscle level
    Arm Title
    Fascia injection
    Arm Type
    Experimental
    Arm Description
    Fascia injection, below upper trapezium muscle
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham injection
    Intervention Description
    Injection to the subcutaneous layer at upper trapezium level
    Intervention Type
    Procedure
    Intervention Name(s)
    Fascia injection
    Intervention Description
    Injection to the fascia below upper trapezium muscle
    Primary Outcome Measure Information:
    Title
    Upper back or shoulder pain
    Description
    visual analogue scale(VAS), range 0-10, the higher the worse pain
    Time Frame
    Change from baseline VAS at 1 week
    Title
    Upper back or shoulder pain
    Description
    visual analogue scale(VAS), range 0-10, the higher the worse pain
    Time Frame
    Change from baseline VAS at 4 week
    Title
    Upper back or shoulder pain
    Description
    visual analogue scale(VAS), range 0-10, the higher the worse pain
    Time Frame
    Change from baseline VAS at 12 week
    Secondary Outcome Measure Information:
    Title
    Function
    Description
    Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
    Time Frame
    Change from baseline SPADI at 1 week
    Title
    Function
    Description
    Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
    Time Frame
    Change from baseline SPADI at 4 week
    Title
    Function
    Description
    Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse
    Time Frame
    Change from baseline SPADI at 12 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu-Hsuan Cheng, MS
    Phone
    +886 229307930
    Ext
    1600
    Email
    heathcyh@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu-Hsuan Cheng, Cheng
    Organizational Affiliation
    Taipei Medical University, Taiwan, R.O.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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