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.

• Conditions: Trapezius muscle pain in patients with fibromyalgia; MedDRA version: 18.0Level: PTClassification code 10048439Term: FibromyalgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-000796-28-ES
• Lead Sponsor: Fundacio Clinic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-15
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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