Electric muscle stimulation for treatment of functional shoulder instability

Not Applicable

Completed

Conditions: on-controllable positional functional posterior shoulder instability (FPSI).
Musculoskeletal Diseases

Registration Number: ISRCTN10085480

Lead Sponsor: Charité - Universitaetsmedizin Berlin

Brief Summary: 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/37870503/ (added 03/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 59

Inclusion Criteria

1. Non-controllable positional functional posterior shoulder instability (FPSI)
2. Aged 13 years or over

Exclusion Criteria

1. Multidirectional instability
2. Static posterior instability/migration
3. Connective tissue disease
4. Degenerative joint disease
5. Structural defects visible on pre-treatment MRI
6. Neurological disorder or nerve injury
7. Existing pain syndrome (defined by pain at rest or during motion, which is not caused by dislocation but impedes physiotherapeutic training and/or EMS)
8. Non-tolerance of EMS treatment (e.g. cardiac pacemaker)
9. Previous participation in a pathology-specific standardized EMS or physiotherapy protocol

Added 21/02/2020:
5. Structural defects visible on pre-treatment MRI:
5.1. Any acquired glenoid bone defect
5.2. Glenoid dysplasia with more than 10° of retroversion (of cartilagineous surface) according to Imhoff et al.
5.3. Convex cartilagineous glenoid articular surface
5.4. Static posterior glenohumeral decentering >55% according to Walch et al.
5.5. Degenerative changes (any visible cartilage damage or OA)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Western Ontario Shoulder Instability Index (WOSI) at T2

Secondary Outcome Measures

Name	Time	Method
1. WOSI at T1, T3, and T4.<br>At 0 weeks (T0), 6 weeks (T1), 3 months (T2), 6 months (T3), 12 months (T4):<br>2. Subjective shoulder value<br>3. Impairment of daily activities<br>4. Sports impairment<br>5. Pain level<br>6. Range of motion<br>7. Strength<br>8. Satisfaction with treatment<br><br>Assessment of safety: Based on the complication-free pilot trial, no adverse events are pre-specified but continuous recording of unexpected adverse events will be executed in both treatment arms.