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

NCT ID: NCT03867604

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-12-01

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.

Conditions

Myofascial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham injection

Subcutaneous injection at upper trapezium muscle level

Group Type: SHAM_COMPARATOR

Sham injection

Intervention Type: PROCEDURE

Injection to the subcutaneous layer at upper trapezium level

Fascia injection

Fascia injection, below upper trapezium muscle

Group Type: EXPERIMENTAL

Fascia injection

Intervention Type: PROCEDURE

Injection to the fascia below upper trapezium muscle

Interventions

Sham injection

Injection to the subcutaneous layer at upper trapezium level

Intervention Type: PROCEDURE

Fascia injection

Injection to the fascia below upper trapezium muscle

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Hsuan Cheng, Cheng

Role: STUDY_DIRECTOR

Taipei Medical University, Taiwan, R.O.C.

Locations

Taipei medical university

Taipei, , Taiwan

Countries

Taiwan

References

Hsu CY, Hsu T, Lin YN, Cheng YH. Additional Effect of Interfascial Hydrodissection With Dextrose on Shoulder and Neck Function in Patients With Myofascial Pain Syndrome: A Randomized Control Trial. Am J Phys Med Rehabil. 2024 Sep 1;103(9):827-834. doi: 10.1097/PHM.0000000000002442. Epub 2024 Jan 31.

Reference Type: DERIVED

PMID: 38320240 (View on PubMed)

Other Identifiers

N201811013

Identifier Type: -

Identifier Source: org_study_id