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Completed

NCT Number: NCT03867604

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

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei medical university

Taipei, 116, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham injection

Procedure

Injection to the subcutaneous layer at upper trapezium level

Fascia injection

Procedure

Injection to the fascia below upper trapezium muscle

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2019
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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