Trigger Point Injection in Patients With Myofascial Pain Syndrome

NCT ID: NCT06555523

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2024-09-20

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.

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.

Conditions

Injection Site; Fibromyalgia

Study Design

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

Study Groups

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

Group Type: EXPERIMENTAL

Ultrasound guided injection

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Blinded injection

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Firat University

OTHER

Sponsor Role: lead

Responsible Party

Songül Bağlan Yentür

Firat University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Songul

Elâzığ, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Songul Baglan Yentur

Role: primary

songulbaglan23@hotmail.com

04242370000

Songul Baglan Yentur

Role: backup

songulbaglan23@hotmail.com

+904242370000 ext. 8282

Other Identifiers

2024/03-10

Identifier Type: -

Identifier Source: org_study_id