Throwing Velocity and Patient Reported Outcomes in Elite Level Handball Players After Completion of Shoulder-Pacemaker Strength Training

Shoulder Dislocation Clinical Trial

Official title:

Throwing Velocity and Patient Reported Outcomes in Elite Level Handball Players After Completion of Shoulder-Pacemaker Strength Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06459258
• Other study ID #: EK22-201-1022
• Secondary ID: EK22-201-1022
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 7, 2024

Study information

• Verified date: June 2024
• Source: Sportorthopädie Zentrum in Wien Hietzing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The successful application of treatment protocols using motion-triggered neuromuscular electrical stimulation (NMES) for treatment-resistant functional posterior shoulder instability was recently demonstrated. The purpose of this study is to evaluate the concept of a motion-triggered NMES training protocol through objective clinical outcome parameters and its impact on external rotational (ER) shoulder strength and throwing velocity in healthy, elite-level handball players.

Description:

The aim of this study is to evaluate the concept of a motion-triggered NMES training protocol through objective clinical outcome parameters and its impact on external rotational (ER) shoulder strength and throwing velocity in healthy, elite-level handball players. It is hypothesized that a 6-week motion-triggered NMES shoulder strengthening training protocol in elite-level handball players would lead to an increase in throwing velocity due to an improved motor ability and ER shoulder strength.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 7, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elite level handball players healthy and actively competing at the time of the study
• Patients must be at least 18 years at the time of signing the informed consent
• Pregnancy must be ruled out in the case of female participants (e.g., pregnancy test)
• Patient must be available for all specified assessments throughout the study duration
• All patients are required to give written informed consent before enrollment

Exclusion Criteria:

• age <18,
• history of type I or II shoulder instability according to the Stanmore classification12,
• existing pain syndrome (defined by pain at rest or during motion that is not caused by dislocation and impedes training),
• recent shoulder surgery (<1 year).
• Contraindication to SPM treatment (e.g., cardiac pacemaker)
• Neurological disorders or nerve injuries causing the instability
• Uncontrolled alcohol or substance abuse

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Other:
• Motion-triggered NMES training protocol
Experimental group subjects undergo a motion-triggered NMES shoulder strengthening training program (3x/week, 30 minutes for 6 weeks) using the Shoulder Pacemaker (NCS Lab Srl, Modena, Italy), a motion activated stimulation device to strengthen muscular disbalances. This is accomplished through varying neuromuscular electrical stimulation intensity based on the angle of motion of the arm producing subtetanic contraction and provoking supraspinal neural adaptations. Electrode placement: electrode 1, inferior to the scapular spine (infraspinatus, teres minor, + posterior deltoid); electrode 2, medial to the medial scapula border (lower trapezius + rhomboids) . Sets x repetitions: 3x20 Levels: Level 1-3; Exercise 1: L1: Supported row, L2: Front raises in 45°, L3 Front raises (thumbs up) Exercise 2: L1: Resisted front raises, L2: Crossbody resisted raises, L3: Crossbody; forehand swing; Exercise 3: L1: Rear dealt fly, L2: Single arm resisted row, L3: Underhand volleyball
• Non-Motion-triggered NMES training protocol
Arm Description: Subjects of the control group undergo a conventional standardized strength training program (3x/week, 30 minutes for 6 weeks) with concentric, eccentric, and functional training exercises.

Locations

Country	Name	City	State
Austria	Sportorthopädie Zentrum	Wien

Sponsors (2)

Lead Sponsor	Collaborator
Sportorthopädie Zentrum in Wien Hietzing	Austrian Research Group for Regenerative and Orthopedic Medicine

Country where clinical trial is conducted

Austria, 

References & Publications (3)

Moroder P, Danzinger V, Maziak N, Plachel F, Pauly S, Scheibel M, Minkus M. Characteristics of functional shoulder instability. J Shoulder Elbow Surg. 2020 Jan;29(1):68-78. doi: 10.1016/j.jse.2019.05.025. Epub 2019 Aug 1. — View Citation

Moroder P, Karpinski K, Akgun D, Danzinger V, Gerhardt C, Patzer T, Tauber M, Wellmann M, Scheibel M, Boileau P, Lambert S, Porcellini G, Audige L. Neuromuscular Electrical Stimulation-Enhanced Physical Therapist Intervention for Functional Posterior Shou — View Citation

Moroder P, Plachel F, Van-Vliet H, Adamczewski C, Danzinger V. Shoulder-Pacemaker Treatment Concept for Posterior Positional Functional Shoulder Instability: A Prospective Clinical Trial. Am J Sports Med. 2020 Jul;48(9):2097-2104. doi: 10.1177/03635465209 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Throwing velocity (km*h-1)	the difference in throwing velocity (km*h-1) from baseline to 6-week post-intervention follow-up.	Baseline to 6-week post-intervention follow-up.
Secondary	Isometric hand-held dynamometer (HHD) ER and internal rotation (IR) maximal shoulder strength	Secondary outcome was the difference in isometric hand-held dynamometer (HHD) ER and internal rotation (IR) maximal shoulder strength at final follow-up.	Baseline to 6-week post-intervention follow-up