Trigger Point Injection in Patients With Myofascial Pain Syndrome

Official title

Comparison of Trigger Point Injection Application Methods in Patients With Fibromyalgia Syndrome and Myofascial Pain Syndrome

Overview

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.

Detailed description

The primary objectives in treating Fibromyalgia Syndrome (FMS) are to deactivate trigger points, alleviate pain, and remove factors that exacerbate the condition. Recently, the use of ultrasound (US) has been advocated to reduce potential complications during trigger point injections and to ensure more effective administration of the treatment.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.

Interventions

• Other Ultrasound guided injection
  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
• Other Blinded injection
  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.

Primary outcome measures

• Pain assessment [Time frame: 1 minute]

Secondary outcome measures (2)

• Neck disability assessment [Time frame: 2 minutes]
• Functional assessment [Time frame: 2 minutes]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Songul — Elâzığ

Identifiers

NCT: NCT06555523 · 2024/03-10

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗