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LOCAL INVASIVE TREATMENT OF TRAPEZIUS MUSCLE PAIN IN PATIENTS WITH FIBROMYALGIA
EU CTIS ID: 2024-520345-23-00
What this study is testing
To compare the efficacy in improving pain, both locally and generalized, in patients with fibromyalgia who present myofascial trapezius pain syndrome, as well as its duration, after regional administration of bupivacaine/triamcinolone vs physiological saline vs placebo. , in the interfascial space between the trapezius and supraspinatus muscles and between the trapezius and levator scapulae muscles.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients Over 18 years old
- Patients who suffer from Fibromyalgia, diagnosed with ACR 1990 criteria and ACR 2010 criteria.
- Patients who have not started a new treatment, or patients who recieve a stable treatment in the last three months.
- Patients who, in the last three months, have received treatment with weak opiates (tramadol or codeine), paracetamol or metamizol as rescue medication, on demand, or as prescribed.
- Presence of spontaneous, continuous pain in the right and/or left upper trapezius lasting more than three months, with palpable bands on examination as well as trigger points in the trapezius, with a local pain intensity scale greater than 3 , according to VAS and generalized pain scale greater than 3.
- Signature of the informed consent.
You likely can't join if
- Presence of other uncontrolled metabolic, endocrinological, cardiovascular and visceral diseases.
- Presence of skin lesions, eczema, skin infections in the drug administration area (trapezius).
- Implanted electrical devices for pain management (neuromodulation).
- Patients who have previously undergone this type of procedure.
- Presence of psychiatric disorders that interfere with the adequate understanding of the treatment to be carried out or of the questionnaires (for example, psychosis or dementia).
- Patients who have been prescribed a new drug for their chronic pain condition or whose dose has been modified in the last three months (including antidepressants, anticonvulsants...).
See the full eligibility criteria
- Patients Over 18 years old
- Patients who suffer from Fibromyalgia, diagnosed with ACR 1990 criteria and ACR 2010 criteria.
- Patients who have not started a new treatment, or patients who recieve a stable treatment in the last three months.
- Patients who, in the last three months, have received treatment with weak opiates (tramadol or codeine), paracetamol or metamizol as rescue medication, on demand, or as prescribed.
- Presence of spontaneous, continuous pain in the right and/or left upper trapezius lasting more than three months, with palpable bands on examination as well as trigger points in the trapezius, with a local pain intensity scale greater than 3 , according to VAS and generalized pain scale greater than 3.
- Signature of the informed consent.
- Presence of other uncontrolled metabolic, endocrinological, cardiovascular and visceral diseases.
- Presence of skin lesions, eczema, skin infections in the drug administration area (trapezius).
- Implanted electrical devices for pain management (neuromodulation).
- Patients who have previously undergone this type of procedure.
- Presence of psychiatric disorders that interfere with the adequate understanding of the treatment to be carried out or of the questionnaires (for example, psychosis or dementia).
- Patients who have been prescribed a new drug for their chronic pain condition or whose dose has been modified in the last three months (including antidepressants, anticonvulsants...).
- Patients who, in the three months prior to inclusion, have received chronic treatment with corticosteroids or strong opiates.
- Presence of other uncontrolled infectious, metabolic or inflammatory neuromuscular diseases.
- Altered coagulation and patients treated with anticoagulants.
- History of surgery on the cervical spine and/or shoulders.
- Presence of active spinal disease in the cervical and/or dorsal segments.
- Presence of active tendon or joint disease affecting the shoulders
- Intolerance, hypersensitivity or allergy to Bupivacaine or other local anesthetics.
- Intolerance, hypersensitivity or allergy to triamcinolone acetonide
- Pregnant or breastfeeding patients.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.