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Completed

NCT Number: NCT02548208

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Sports Medicine, Institute of Sports Sciences, Goethe University

Frankfurt am Main, 60487, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy subjects
  • age 18+
  • voluntariness

Exclusion criteria

  • pain
  • pregnancy
  • musculoskeletal disease
  • systemic neurological disease
  • cancer
  • coagulation disorder
  • mental illness
  • drug addiction
  • allergy to the ultrasound gel
  • cardiac illness
  • vascular disease of the limbs or the central nervous system
  • regional scars
  • regional skin transplants or hypoesthesia
  • allergic or other forms of acute dermatitis
  • chronic intake of analgesic, neuroleptics, antidepressants, corticoids or alpha2-blockers
  • current state of delayed onset muscle soreness
  • extracorporeal shockwave therapy within last 2 weeks

Treatment and study plan

Verum focused extracorporeal shockwave

Device

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

Device

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Dr. Johannes Fleckenstein

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2015
Registry last updated
Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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