Overview
Sponsor-declared trial summary
TRAPEZIUS MYOFASCIAL SYNDROME IN FIBROMYALGIA PATIENTS
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…
Key facts
- Sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2025-01-15
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-520345-23-00
- EudraCT number
- 2022-002717-41
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
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.
Secondary objectives 2
- Analyze if there are differences, before and after administration of active drug (Bupivacaine and triamcinolone), in general pain, sleep quality, mood, quality of life and functional capacity of these patients.
- To compare whether there is a significant difference in the effect of the active drug (chemical + mechanical action) vs physiological saline (only mechanical action) in reducing the symptoms of these patients.
Conditions and MedDRA coding
TRAPEZIUS MYOFASCIAL SYNDROME IN FIBROMYALGIA PATIENTS
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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.
Exclusion criteria 15
- Presence of other uncontrolled metabolic, endocrinological, cardiovascular and visceral diseases.
- 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.
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Visual Analogue Scale (VAS) of regional trapezius pain selected for treatment, at weeks 2, 4 and 12.
Secondary endpoints 8
- Visual Analogue Scale (VAS) of the patient's general pain
- Visual Analog Scale (VAS) of patient fatigue
- Sensitivity points measured by algometer with a force of 4 kg
- WPI and SSS
- Sleep assessment: Pittsburg Index (PSQI).
- Functional Capacity (FIQ).
- Quality of Life (SF-36)
- Level of anxiety / depression (HAD).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Bupivacaína Physan 0,25% Solución Inyectable
PRD8152846 · Product
- Active substance
- Bupivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 4.5 ml millilitre(s)
- Max total dose
- 4.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB01 — BUPIVACAINE
- Marketing authorisation
- 57.109
- MA holder
- LAPHYSAN, S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KENACORT 40 mg/ml sospensione iniettabile
PRD363662 · Product
- Active substance
- Triamcinolone Acetonide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB08 — TRIAMCINOLONE
- Marketing authorisation
- 013972056
- MA holder
- BRISTOL-MYERS SQUIBB S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Suero Fisiológico Braun 0,9% disolvente para uso parenteral Cloruro de sodio
PRD567870 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 10 ml millilitre(s)
- Max total dose
- 10 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 58449
- MA holder
- B.BRAUN MEDICAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
Lidocaína B. Braun 20 mg/ml solución inyectable
PRD575184 · Product
- Active substance
- Lidocaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01B — ANESTHETICS, LOCAL
- Marketing authorisation
- 44792
- MA holder
- B.BRAUN MEDICAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Sponsor organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Address
- Calle Rosellon 149-153
- City
- Barcelona
- Postcode
- 08036
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Tamara Libertad Rodriguez
Public contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Tamara Libertad Rodriguez
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 69 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-520345-23-00 | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_redacted | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC bupivacaina | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC suero fisiologico | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC triamcinolona acetonido inyectable | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-24 | Spain | Acceptable 2025-01-15
|
2025-01-15 |