Clinical trial NCT06459258: Throwing Velocity and Patient Reported Outcomes in Elite Level Handball Players After Completion of Shoulder-Pacemaker Strength Training
Official title: Throwing Velocity and Patient Reported Outcomes in Elite Level Handball Players After Completion of Shoulder-Pacemaker Strength Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Keywords: Motion-Triggered Neuromuscular Electrical Stimulation-Enhanced Strength Training
Lead sponsor: Sportorthopädie Zentrum in Wien Hietzing
Sponsor class: OTHER
Collaborators: name: Austrian Research Group for Regenerative and Orthopedic Medicine
First posted: 2024-06-14
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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 \&lt;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 (\&lt;1 year).
* Contraindication to SPM treatment (e.g., cardiac pacemaker)
* Neurological disorders or nerve injuries causing the instability
* Uncontrolled alcohol or substance abuse

Primary outcomes:
measure: Throwing velocity (km*h-1)
timeFrame: Baseline to 6-week post-intervention follow-up.
Secondary outcomes:
measure: Isometric hand-held dynamometer (HHD) ER and internal rotation (IR) maximal shoulder strength
timeFrame: Baseline to 6-week post-intervention follow-up
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Sportorthopädie Zentrum
Study officials:
References:
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 Shoulder Instability (Type B1): A Multicenter Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad145. doi: 10.1093/ptj/pzad145.
citation: 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.
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: 10.1177/0363546520933841.