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

Dr. Johannes Fleckenstein

Status: Completed

Conditions: Musculoskeletal Pain; Athletic Injuries

Treatments: Device: Sham shock wave; Device: Verum focused extracorporeal shockwave

Study type: Interventional

Funder types: Other

Identifiers

NCT02548208

ESWT_DOMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 3 patient groups

Verum focused extracorporeal shockwave therapy

Active Comparator group

Description:

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.

Treatment:

Device: Verum focused extracorporeal shockwave

Sham shock wave

Sham Comparator group

Description:

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.

Treatment:

Device: Sham shock wave

Control

No Intervention group

Description:

Control procedure stipulates participants to lay down on the same therapy table for 5 minutes receiving no intervention.