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Study comparing the effect on pain and function of an anaesthetic injection with a placebo (non-active substance) for the treatment of pain at the trapezius muscle.

A pilot, single-blind, placebo-controlled study to assess efficacy and safety of interfascial blockade of the painful trapezius muscle in patients with fribromyalgia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-000796-28-ES
Enrollment
Unknown
Registered
2015-06-15
Start date
2015-08-07
Completion date
Unknown
Last updated
2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trapezius muscle pain in patients with fibromyalgia MedDRA version: 18.0 Level: PT Classification code 10048439 Term: Fibromyalgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Bupivacaína B. Braun 2,5 mg/ml solución inyectable. Pharmaceutical Form: Solution for injection INN or Proposed INN: Bupivacaíne hidrocloruro Other descriptive name: BUPIVACAINE HYDROCHLOR

Sponsors

Fundacio Clinic per a la Recerca Biomèdica
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18 or more 2. Patients diagnosed of Fibromyalgia as primary cause of pain, according ACR 1990 criteria 3. Not treated or on stable treatment for the last 3 months 4. Spontaneous continuous pain at the upper trapezius muscle for more than three months with a VAS intensity above 4, 5. Signed Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: 1.Any non-controlled condition or disease (cardiovascular, endocrine, etc) 2. Other neuromuscular, infectious, metabolic or inflammatory diseases. 3. Current anticoagulant therapy or coagulation abnormalities 4. Prior surgery at shoulder or spine level 5. Active vertebral disease (cervical or thoracic) 6. Joint or tendon disease affecting shoulder area 7. Intolerance or hypersensitivity to bupivacaine or other local anaesthetic agents 8. Pregnant or nursing women 9. Skin lesions at the injection site 10. Implantable devices for pain neuromodulation 11. Patients undergoing the procedure previously

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the degree and duration of pain control in patients with fibromyalgia after a single injection of bupivacaine or placebo between trapezius and supraspinatus muscles;Secondary Objective: To compare the degree and duration of pain control in patients with fibromyalgia after a single injection of bupivacaine or placebo between trapezius and supraspinatus muscles;Primary end point(s): Regional pain VAS at the trapezius muscle;Timepoint(s) of evaluation of this end point: measured at weeks 2, 4 and 12 after treatment—

Secondary

MeasureTime frame
Secondary end point(s): General pain VAS Sleep quality Pittsburg Index (PSQI) Functional capacity(FIQ) QoL (SF-36) Anxiety / Deppression (HAD);Timepoint(s) of evaluation of this end point: measured at weeks 2, 4 and 12 after treatment—

Countries

Spain

Contacts

Public ContactUnidad de Fibromialgia

Hospital Clinic Barcelona

34932275400

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026