Clinical Trial: Single Focused Shock Wave in the Release od Delayed Onset Muscle Soreness (DOMS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of a Single Administration of Focused Extracorporeal Shock Wave in the Relief of Delayed-Onset Muscle Soreness

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Dr. Johannes Fleckenstein

Current Primary Outcome: Pain intensity [ 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pressure pain threshold (PPT) [ 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).
  • Maximum isometric voluntary force MIVF [ Time Frame: 72 hours ]
    MIVF is easured using a strain-gauge force transducer (ASYS® SPOREG, Offenbach, Germany). Peak strength values (N) are recorded.
  • Activities of daily living (ADL) [ 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.


Original Secondary Outcome: Same as current

Information By: Goethe University

Dates:
Date Received: September 9, 2015
Date Started: January 2011
Date Completion:
Last Updated: September 11, 2015
Last Verified: September 2015