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

Not Applicable

Completed

• Conditions: Musculoskeletal Pain; Athletic Injuries
• Interventions: Device: Verum focused extracorporeal shockwave; Device: Sham shock wave

• Registration Number: NCT02548208
• Lead Sponsor: Dr. Johannes Fleckenstein

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 Description

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2015-09
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-11
• Last Update Submitted: 2015-09-11
• Study First Posted: 2015-09-14
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum focused extracorporeal shockwave therapy	Verum focused extracorporeal shockwave	Verum focused extracorporeal shockwave therapy is applied at 7 equidistant points, perpendicular to the belly of the biceps brachii muscle on a thought line between the radial tuberosity and the coracoid process (Dermagold120, Tissue Regeneration Technologies, Woodstock, Georgia, U.S.). Shock waves are generated by electrohydraulic mechanisms.
Sham shock wave	Sham shock wave	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. The study personal is blinded to the applicators. All handling, adjustments and noises are thus same in this group.

Primary Outcome Measures

Name	Time	Method
Pain intensity	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 Outcome Measures

Name	Time	Method
Pressure pain threshold (PPT)	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	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)	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.

Trial Locations

Locations (1)

Department of Sports Medicine, Institute of Sports Sciences, Goethe University; 🇩🇪 Frankfurt am Main, Germany