About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Ultrasound guided injection
Other interventionThe 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
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Functional assessment
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.
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