Hospital Clinic De Barcelona
Barcelona, Spain
Not yet recruitingFibromyalgiaMyofascial pain syndrome
Study on Pain Relief for Fibromyalgia Patients with Trapezius Myofascial Syndrome Using Bupivacaine, Triamcinolone, and Sodium Chloride
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the treatment of pain in patients with fibromyalgia, a condition characterized by widespread pain and tenderness. Specifically, the study targets trapezius myofascial syndrome, which involves pain in the trapezius muscle, a large muscle extending over the back of the neck and shoulders. The treatment being tested involves an injection into the muscle using different substances: bupivacaine, a local anesthetic; triamcinolone acetonide, an anti-inflammatory medication; and a physiological saline solution, which is a simple saltwater solution. Some participants will receive a placebo.
The purpose of the study is to compare how effective these treatments are in reducing pain in the trapezius muscle and overall body pain in fibromyalgia patients. The study will involve injections guided by ultrasound to ensure accuracy, targeting specific areas between muscles in the shoulder region. Participants will receive these treatments and will be monitored over a period of time to assess changes in their pain levels and overall well-being.
Throughout the study, participants will be asked to report their pain levels and other symptoms at various intervals. This will help researchers understand the duration and effectiveness of the pain relief provided by each treatment. The study aims to provide insights into better managing pain for those suffering from fibromyalgia and trapezius myofascial syndrome.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Patients must be **over 18 years old**.
- Patients must have **fibromyalgia**, which is a condition that causes widespread pain, diagnosed using specific criteria from 1990 and 2010.
- Patients should not have started a new treatment recently, or they should have been on a **stable treatment** for the last three months.
- In the last three months, patients should have used **weak opiates** like tramadol or codeine, or pain relievers like paracetamol or metamizol, either as needed or as prescribed.
- Patients must have **continuous pain** in the upper trapezius area (a muscle in the upper back and neck) for more than three months, with noticeable tight bands and **trigger points** (sensitive spots) in the muscle. The pain should be rated more than 3 on a local pain scale and a generalized pain scale.
- Patients must sign the **informed consent**, which is a document that explains the study and confirms their willingness to participate.
Who cannot join the trial?
10 criteria
- Patients who do not have fibromyalgia with trapezius myofascial syndrome. Fibromyalgia is a condition that causes widespread pain, and trapezius myofascial syndrome is a specific type of muscle pain in the upper back.
- Patients who are not within the specified age range for the study.
- Patients who are not able to provide informed consent or understand the study requirements.
- Patients who have other medical conditions that might interfere with the study or its results.
- Patients who are currently participating in another clinical trial.
- Patients who have allergies or adverse reactions to the medications used in the study, such as bupivacaine or triamcinolone. Bupivacaine is a medication used to numb an area, and triamcinolone is a type of steroid used to reduce inflammation.
- Patients who are pregnant or breastfeeding.
- Patients with a history of substance abuse or dependency.
- Patients who have had recent surgery or are planning to have surgery during the study period.
- Patients with severe mental health conditions that might affect their ability to participate in the study.
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Investigated drugs
Bupivacaine
is a medication used to numb a specific area of the body to relieve pain. In this trial, it is administered to patients with fibromyalgia who have myofascial trapezius pain syndrome. The goal is to see if it can help reduce pain in the affected area and improve overall comfort.
Triamcinolone
is a type of steroid that helps reduce inflammation and pain. In this study, it is used in combination with bupivacaine to see if it can provide additional relief for patients suffering from pain associated with fibromyalgia and myofascial trapezius pain syndrome.
Physiological Saline
is a simple saltwater solution that is often used in medical treatments as a control to compare the effects of other medications. In this trial, it is used to help determine the effectiveness of bupivacaine and triamcinolone in treating pain.
What is already known about the treatment
Bupivacaine
Bupivacaine is administered through an injection, specifically as an interfascial block guided by ultrasound. It is currently used in clinical settings for pain management and is well-documented in medical literature. The main therapeutic indication is to alleviate pain in patients with fibromyalgia who have trapezius myofascial syndrome. Bupivacaine works by blocking nerve signals in the body, preventing pain signals from reaching the brain. It is classified as a local anesthetic.
Triamcinolone
Triamcinolone is administered via injection into the interfascial space, guided by ultrasound. It is widely recognized in medical literature and used for its anti-inflammatory properties. The primary therapeutic use is to reduce inflammation and pain in fibromyalgia patients with trapezius myofascial syndrome. Triamcinolone acts by suppressing the immune response and reducing inflammation at the molecular level. It belongs to the class of corticosteroids.
Physiological Saline
Physiological saline is administered through an injection into the interfascial space, guided by ultrasound. It is commonly used in medical practice as a control substance in clinical trials. In this context, it serves as a comparison to evaluate the effectiveness of other treatments in managing pain associated with trapezius myofascial syndrome in fibromyalgia patients. Physiological saline does not have an active mechanism of action but is used to maintain fluid balance and as a placebo in trials.
Investigated diseases
Fibromyalgia
A chronic condition characterized by widespread musculoskeletal pain, fatigue, and tenderness in localized areas. It often involves symptoms such as sleep disturbances, memory issues, and mood swings. The pain associated with fibromyalgia is typically described as a constant dull ache that has lasted for at least three months. It is believed to amplify painful sensations by affecting the way the brain processes pain signals. The condition can also lead to increased sensitivity to pain, known as hyperalgesia, and may be accompanied by other symptoms like headaches and irritable bowel syndrome.
Trapezius Myofascial Pain Syndrome
A condition involving pain and tenderness in the trapezius muscle, which is located in the upper back and neck. This syndrome is characterized by the presence of trigger points, which are tight bands of muscle fibers that can cause pain in the affected area and sometimes refer pain to other parts of the body. The pain is often described as a deep, aching sensation and can be exacerbated by physical activity or stress. It may also lead to stiffness and limited range of motion in the neck and shoulders. This condition is commonly seen in individuals with fibromyalgia, where it contributes to the overall pain experience.
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Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520345-23-00Protocol codeTRAPEZIUSEstimated enrolment69 patientsSponsorFundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
sourced from the EU Clinical Trials Register and site verification
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