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Recruiting NCT07611006

Impact of Neuromuscular Control With and Without Electrical Stimulation and Long-term Effect of Kinetic Chain Exercises in Multidirectional Shoulder Instability Patients

No phase Interventional Multidirectional Instability Hypermobility Spectrum Disorder Electrical Stimulation Neuromuscular Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: neuromuscular eletrical stimulation, neuromuscular control training.
Who it may be relevant to
Registry conditions: Multidirectional Instability, Hypermobility Spectrum Disorder, Electrical Stimulation, Neuromuscular Control. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Background: Shoulder instability is commonly observed in adolescents and young females, ranging from asymptomatic multidirectional instability (MDI) to symptomatic conditions. Patients with MDI often experience shoulder pain, muscle tension, and episodes of subluxation. This condition is associated with hypermobility spectrum disorder (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS), both characterized by generalized joint laxity and recurrent joint dislocations, significantly affecting daily activities and athletic performance. Current literature lacks clarity on the actual humeral head displacement, shoulder joint kinetics, and muscle activity characteristics during movement in patients with MDI accompanied by HSD or hEDS. Additionally, the effects of electrical stimulation on different shoulder muscles and its impact on humeral head displacement in MDI patients remain to be validated. Objective: The purposes of this study are to (1) examine whether patients with hEDS/HSD and MDI have increased humeral head translation compared to healthy controls during three isometric contraction ; (2) investigate the relationship between humeral head translation and associated muscle activity during three isometric exercises ; (3) examine the effect of NMES and NMCT to humerus/scapula muscles on humeral head translations in MDI patients with hEDS/HSD Outcome measurements: The primary outcomes include changes in acromiohumeral distance (AHD) or humeroglenoid distance (HGD) under four conditions (no stimulation, NMCT, BLH/Infraspinatus/MD stimulation, and SA stimulation) during three isometric contractions (shoulder flexion, horizontal adduction, and fully extended elbow holding weight). The secondary outcomes assess muscle activation differences in BLH, infraspinatus, MD, UT, LT, and SA before and after NMCT.

Interventions

  • Behavioral neuromuscular eletrical stimulation
    The GM300TE COMBO NMES (Gemore Technology Co., Ltd., New Taipei City, Taiwan), a portable machine with dual controllable channels and a manual switch, will be applied to the biceps long head, infraspinatus, middle deltoid, LT and SA. Muscle force generation is modulated by stimulated frequency, pulse width, and intensity \[Bdaiwi et al., 2015\]. It linearly increases with stimulated amplitude and pulse duration. The electronics of the unit creates the electrical impulses with an output frequency
  • Behavioral neuromuscular control training
    To ensure that the humeral head remains centered during the three specific isometric tasks, the examiner positioned the shoulder according to the direction of instability (anterior, inferior, or posterior) by placing the arm in 20° of shoulder flexion, 0° (neutral), or 10° of extension, respectively. In each position, the examiner gently applied a downward force on the upper arm in a horizontal direction, and the participant was instructed to gently resist the force. The goal was to guide the hu

Primary outcome measures

  • Western Ontario Shoulder Index (WOSI) [Time frame: At baseline, week 4, and week 8 after the intervention]

Eligibility criteria

Inclusion criteria

  • Age: Between 20 and 50 years old.

Patients with Multidirectional Shoulder Instability Must Meet the Following Conditions:

(A) Generalized Joint Hypermobility: Beighton score ≥ 4/9. (B) Shoulder Laxity Verified in at Least Two Directions During Clinical Examination (must meet A and B, or A and C): Inferior: Presence of a sulcus sign under the acromion or a positive Gagey hyperabduction test.

Anterior: Positive anterior load and shift test or active shoulder external rotation > 85 degrees or passive shoulder external rotation > 90 degrees.

Posterior: Positive posterior load and shift test or positive posterior jerk test.

(C) Shoulder Pain for at Least Three Months Before the Start of the Study. (D) Signs of Shoulder Instability in Daily Life Without a Traumatic Cause. (E) Ability to Raise the Arm Above 120 Degrees Without Experiencing Subluxation or Dislocation of the Shoulder.

Exclusion criteria

  • Shoulder pain caused by trauma. History of shoulder fractures or dislocations. Cervical radiculopathy. Degenerative joint disease of the shoulder. Previous shoulder surgery. Frozen shoulder. Pain score greater than 5 during experimental movements. Redness, swelling, or open wounds on the skin within the experimental area. Sensory abnormalities. Cognitive impairment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • School and graduate institution of physical therapy — Taipei

Identifiers

NCT: NCT07611006 · 202501014RINA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗