Study on Pain Relief for Fibromyalgia Patients with Trapezius Myofascial Syndrome Using Bupivacaine, Triamcinolone, and Sodium Chloride

3 1 1 1

What is this study about?

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.

1 initial assessment

An initial assessment is conducted to confirm eligibility for the trial. This includes verifying the presence of trapezius myofascial syndrome in patients with fibromyalgia.

Eligibility criteria include being over 18 years old, having a fibromyalgia diagnosis, and experiencing continuous pain in the upper trapezius for more than three months.

2 informed consent

The patient is required to sign an informed consent form, acknowledging understanding of the trial’s procedures and objectives.

3 treatment administration

The treatment involves an ultrasound-guided interfascial block of the trapezius muscle.

Medications used include triamcinolone acetonide, sodium chloride, lidocaine hydrochloride, and bupivacaine hydrochloride, all administered via intramuscular injection.

The objective is to compare the effectiveness of these medications in reducing pain.

4 follow-up assessments

Pain levels are assessed using the Visual Analogue Scale (VAS) at weeks 2, 4, and 12.

Additional assessments include general pain, fatigue, sensitivity points, sleep quality, functional capacity, quality of life, and levels of anxiety or depression.

5 trial completion

The trial is estimated to conclude by June 26, 2025.

Final assessments are conducted to evaluate the overall effectiveness and safety of the treatment.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Hospital Clinic De Barcelona	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	26.06.2023

Trial locations

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.

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.

Trial ID:

2024-520345-23-00

Protocol code:

TRAPEZIUS

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Pain Relief for Fibromyalgia Patients with Trapezius Myofascial Syndrome Using Bupivacaine, Triamcinolone, and Sodium Chloride

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?