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Electric muscle stimulation for treatment of functional shoulder instability

Electric muscle stimulation for treatment of non-controllable positional functional posterior shoulder instability

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10085480
Enrollment
65
Registered
2019-04-05
Start date
2019-06-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Non-controllable positional functional posterior shoulder instability (FPSI). Musculoskeletal Diseases

Interventions

In a multicentric prospective randomized controlled trial, we would like to objectively assess a promising new EMS-based treatment concept which was evaluated at our institution in a prospective pilot

Sponsors

Charité - Universitaetsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Western Ontario Shoulder Instability Index (WOSI) at T2

Secondary

MeasureTime frame
1. WOSI at T1, T3, and T4. At 0 weeks (T0), 6 weeks (T1), 3 months (T2), 6 months (T3), 12 months (T4): 2. Subjective shoulder value 3. Impairment of daily activities 4. Sports impairment 5. Pain level 6. Range of motion 7. Strength 8. Satisfaction with treatment 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.

Countries

Germany, Switzerland

Outcome results

None listed

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