NCT03867604

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 13, 2024

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

January 21, 2019

Last Update Submit

March 12, 2024

Conditions

Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (3)

  • Upper back or shoulder pain

    visual analogue scale(VAS), range 0-10, the higher the worse pain

    Change from baseline VAS at 1 week

  • Upper back or shoulder pain

    visual analogue scale(VAS), range 0-10, the higher the worse pain

    Change from baseline VAS at 4 week

  • Upper back or shoulder pain

    visual analogue scale(VAS), range 0-10, the higher the worse pain

    Change from baseline VAS at 12 week

Secondary Outcomes (3)

  • Function

    Change from baseline SPADI at 1 week

  • Function

    Change from baseline SPADI at 4 week

  • Function

    Change from baseline SPADI at 12 week

Study Arms (2)

Sham injection

SHAM COMPARATOR

Subcutaneous injection at upper trapezium muscle level

Procedure: Sham injection

Fascia injection

EXPERIMENTAL

Fascia injection, below upper trapezium muscle

Procedure: Fascia injection

Interventions

Sham injectionPROCEDURE

Injection to the subcutaneous layer at upper trapezium level

Sham injection
Fascia injectionPROCEDURE

Injection to the fascia below upper trapezium muscle

Fascia injection

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • diagnosed as a myofascial pain syndrome at upper trapezium muscle
  • trigger point
  • taut band
  • refer pain while taut band irritation

You may not qualify if:

  • Cognitive impairment.
  • Post operation at neck and shoulder.
  • Nerve compression at cervical region.
  • Could not receive injection therapy, history of fainting during needling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei medical university

Taipei, 116, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 38320240DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Yu-Hsuan Cheng, Cheng

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

March 8, 2019

Study Start

June 1, 2019

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

March 13, 2024

Record last verified: 2019-01

Locations

TW(1)