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

Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548208
• Other study ID #: ESWT_DOMS
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: September 11, 2015
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2015
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Athletic Injuries
• Musculoskeletal Pain
• Myalgia

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Department of Sports Medicine, Institute of Sports Sciences, Goethe University	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Johannes Fleckenstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	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).	72 hours	No
Secondary	Pressure pain threshold (PPT)	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).	72 hours	No
Secondary	Maximum isometric voluntary force MIVF	MIVF is easured using a strain-gauge force transducer (ASYS® SPOREG, Offenbach, Germany). Peak strength values (N) are recorded.	72 hours	No
Secondary	Activities of daily living (ADL)	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.	72 hours	No