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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-guided injection | Experimental | 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 |
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| Blinded injection | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided injection | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neck disability assessment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Songul | Recruiting | Elâzığ | 23100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009209 | Myofascial Pain Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Blinded injection | 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. |
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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 |
| D009422 |
| Nervous System Diseases |