Trigger Point Injection in Patients With Myofascial Pain Syndrome

August 13, 2024 updated by: Songül Bağlan Yentür, Firat University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: 1 minute
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck disability assessment
Time Frame: 2 minutes
Neck Disability Questionnaire will be used. It consists of 10 questions questioning the effect of neck pain on pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/study, driving, sleep and social activities.
2 minutes
Functional assessment
Time Frame: 2 minutes
Fibromyalgia Impact Questionnaire will be used. The FIQ is a 10-item scale that evaluates the health status and physical function of patients with fibromyalgia syndrome.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2024

Primary Completion (Estimated)

September 20, 2024

Study Completion (Estimated)

September 20, 2024

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/03-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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