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

NCT ID: NCT02548208

Last Updated: 2015-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Musculoskeletal Pain; Athletic Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Verum focused extracorporeal shockwave therapy

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.

Group Type: ACTIVE_COMPARATOR

Verum focused extracorporeal shockwave

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sham shock wave

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Verum focused extracorporeal shockwave

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

focused extracorporeal shockwave therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Johannes Fleckenstein

OTHER

Sponsor Role: lead

Responsible Party

Dr. Johannes Fleckenstein

Senior Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Winfried Banzer, Prof

Role: STUDY_DIRECTOR

Department of Sports Medicine, Institute of Sports Sciences, Goethe-University Frankfurt, Germany

Locations

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

Frankfurt am Main, , Germany

Countries

Germany

References

Fleckenstein J, Friton M, Himmelreich H, Banzer W. Effect of a Single Administration of Focused Extracorporeal Shock Wave in the Relief of Delayed-Onset Muscle Soreness: Results of a Partially Blinded Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 May;98(5):923-930. doi: 10.1016/j.apmr.2016.11.013. Epub 2016 Dec 16.

Reference Type: DERIVED

PMID: 27993588 (View on PubMed)

Other Identifiers

ESWT_DOMS

Identifier Type: -

Identifier Source: org_study_id