Intra-articular injection of botulinum toxin for treatment of shoulder pain after stroke.

Conditions: hemiplegic shoulder pain
MedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-004682-32-IT

Lead Sponsor: FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Patients with hemiparesis and shoulder pain due to first stroke (ischemic or hemorrhagic) admitted in a rehabilitative department to carry out a standard post-acute rehabilitative program.
•Age 18-70 years.
•Pain score of 45 or greater on a 0-100 mm pain visual analog scale (VAS; 0 = no pain, 100 = worst possible pain).
•Duration of HSP for at least one month.
•Pain refractoriness to conventional treatment i.e. common analgesics (such as paracetamol and NSAIDs), slings, strapping and handling of the arm, functional electrical stimulation of shoulder muscles.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

•Significant spasticity in the upper shoulder joint, defined as a score of 2 or more at the modified Ashworth scale.
•History of shoulder pain or shoulder diseases.
•History of neurological diseases (i.e. Parkinson disease, dystonia).
•History of botulinum toxin treatment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to confirm the efficacy and safety of the intra-articular injection of BT-A in a multicentric double blind randomised study.;Secondary Objective: Improvement of upper limb functions and activity. <br>Improvement of quality of life;Primary end point(s): The primary efficacy outcome will be the reduction in pain severity, measured by VAS score after 4 weeks of treatment, with respect to baseline evaluation.;Timepoint(s) of evaluation of this end point: four weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy outcome will include the following measures: VAS score at the other time points of the study (1 week, 2 weeks, 3 months and 6 months after the treatment), Shoulder Pain and Disability Index (SPADI), Modified Ashworth Scale (MAS), Fugl Meyer Assessment Scale (FMAS), NIH Stroke Scale index (NISS), Functional Independent Measure (FIM), quality of life on short-form (SF)-36 subscales (SF-36).;Timepoint(s) of evaluation of this end point: six months