Department of Sports Medicine, Institute of Sports Sciences, Goethe University
Frankfurt am Main, 60487, Germany
NCT Number: NCT02548208
The study is a single-center, double blinded, randomized controlled trial aimed to investigate the effects of focused extracorporeal shockwave therapy (fESWT) on Delayed Onset Muscle Soreness (DOMS) of the non-dominant biceps brachialis muscle in healthy voluntary adults.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Frankfurt am Main, 60487, Germany
Forty-five participants agreed to participate and signed a written informed consent. After enrollment, muscle soreness was induced and participants were subsequently randomized to receive either (1) focused extracorporeal shockwave therapy (Verum), (2) sham shock wave (Sham) or (3) no treatment (Control). Thereafter, treatments were administered once, only. Measures were repeated after the treatment and at 24, 48 and 72 hours. Main outcome parameter was the pain intensity at rest and in movement as assessed by visual analogue scale (VAS) in the elbow region of the non-dominant arm. Secondary outcome included the pressure pain threshold (PPT) over the biceps muscle belly, the maximum isometric voluntary force (MIVF) of the elbow flexors and the assessing the impairment of activities of the daily living. Participants were followed-up 72 hours after the induction of Delayed Onset Muscle Soreness.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the concentrated shockwave energy per unit area (energy flux density EFD) can vary from 0.06 to 0.09 mJ/mm2. The pulse ratio per point is 200.
Other names: focused extracorporeal shockwave therapy
Sham shock wave is performed using the same device as stated above, but using a special applicator that has been isolated with layers of metal and water by the manufacturer, extinguishing the transmitted energy.
Time frame: 72 hours
Pain intensity at the elbow region during active movement of the biceps muscle is assessed using a visual analogue scale (VAS) ranging from 0 to 10 cm (with 0 indicating no pain and 10 experiencing the worst imaginable pain).
Time frame: 72 hours
PPT is assessed using a mechanical pressure algometer (pdt, Rome, Italy) with increasing force at a rate of approximately 1 kg/cm2/s until the participant reported a painful sensation; and the force value is recorded (kg/cm2).
Time frame: 72 hours
MIVF is easured using a strain-gauge force transducer (ASYS® SPOREG, Offenbach, Germany). Peak strength values (N) are recorded.
Time frame: 72 hours
This test comprises the asssessment of the impairment of six complex movements (each on a VAS 0-10 cm) and the mean VAS of all items is kept to describe the impairment.
Dr. Johannes Fleckenstein
Other
Effect of a Single Administration of Focused Extracorporeal Shock Wave in the Relief of Delayed-Onset Muscle Soreness
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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