Trigger Point Injection in Patients With Myofascial Pain Syndrome
Comparison of Trigger Point Injection Application Methods in Patients With Fibromyalgia Syndrome and Myofascial Pain Syndrome
1 other identifier
interventional
20
1 country
1
Brief Summary
This study aims to compare the effectiveness of blinded versus ultrasound-guided trigger point injections into the trapezius muscle in patients with FMS. Seventy-five patients with FMS will participate in this study. They will be randomly assigned to one of two groups: one group received ultrasound-guided trigger point injections, while the other group received blinded trigger point injections. Both groups will follow the same home exercise regimen, which included stretching and posture exercises targeting the trapezius and pectoral muscles. The effectiveness of the treatments was evaluated one month post-treatment. The assessment tools will include the Fibromyalgia Impact Questionnaire (FIQ) for function, the Visual Analog Scale (VAS) for pain, the Beck Anxiety Inventory (Beck-A) for anxiety, and the Neck Disability Questionnaire (NDQ) for neck disability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2024
CompletedFirst Posted
Study publicly available on registry
August 15, 2024
CompletedStudy Start
First participant enrolled
August 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2024
CompletedAugust 15, 2024
August 1, 2024
1 month
August 13, 2024
August 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain assessment
The pain levels of the patients in the last week will be questioned using a 0-10 cm long Visual Analog Scale (VAS). "0" indicated that the patient have no pain and "10" indicated that the patient's pain is unbearably severe
1 minute
Secondary Outcomes (2)
Neck disability assessment
2 minutes
Functional assessment
2 minutes
Study Arms (2)
Ultrasound-guided injection
EXPERIMENTALThe skin will be cleaned with a suitable antiseptic solution and a sterile, 25 G, 1.5 inch dental-tipped needle will be used. Patients will be injected with 5 ml 2% lidocaine + 5 ml 0.9% NaCl. The linear probe (PLT-704SBT, 7.5 MHz) of the ultrasound device will be kept parallel to the trapezoidal fibers on the marked trigger point and the dental-tipped needle will be directed to the targeted point in plane with real-time imaging
Blinded injection
EXPERIMENTALThe skin will be cleaned with a suitable antiseptic solution and a sterile, 25 G, 1.5 inch dental-tipped needle will be used. Patients will be injected with 5 ml 2% lidocaine + 5 ml 0.9% NaCl. The needle will be directed to the most sensitive point and advanced until it will be reached the trigger point.
Interventions
The skin will be cleaned with a suitable antiseptic solution and a sterile, 25 G, 1.5 inch dental-tipped needle will be used. Patients will be injected with 5 ml 2% lidocaine + 5 ml 0.9% NaCl. The linear probe (PLT-704SBT, 7.5 MHz) of the ultrasound device will be kept parallel to the trapezoidal fibers on the marked trigger point and the dental-tipped needle will be directed to the targeted point in plane with real-time imaging
The skin will be cleaned with a suitable antiseptic solution and a sterile, 25 G, 1.5 inch dental-tipped needle will be used. Patients will be injected with 5 ml 2% lidocaine + 5 ml 0.9% NaCl. The needle will be directed to the most sensitive point and advanced until it will be reached the trigger point.
Eligibility Criteria
You may qualify if:
- Patients aged 20-60 years who met the 2013 ACR criteria
- Patients who will be diagnosed with FMS and cervical chronic MAS according to Travel and Simons' criteria
- Patients who had a palpated tense band in the upper trapezius muscle and at least 1 active trigger point
You may not qualify if:
- Patients with a diagnosis of cervical radiculopathy, myelopathy, local or systemic infection, treatment for MAS in the last 3 months
- Patients who have symptom duration less than 3 months
- Patients with pregnancy status, acute or chronic disease that would cause clinical confusion at the time of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Firat Universitylead
Study Sites (1)
Songul
Elâzığ, 23100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Firat University
Study Record Dates
First Submitted
August 13, 2024
First Posted
August 15, 2024
Study Start
August 20, 2024
Primary Completion
September 20, 2024
Study Completion
September 20, 2024
Last Updated
August 15, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share