Clinical trial NCT02548208: Single Focused Shock Wave in the Release od Delayed Onset Muscle Soreness (DOMS)
Official title: Effect of a Single Administration of Focused Extracorporeal Shock Wave in the Relief of Delayed-Onset Muscle Soreness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Athletic Injuries
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: 72 hours
Secondary outcomes:
measure: Pressure pain threshold (PPT)
timeFrame: 72 hours
measure: Maximum isometric voluntary force MIVF
timeFrame: 72 hours
measure: Activities of daily living (ADL)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of Sports Medicine, Institute of Sports Sciences, Goethe University
Study officials:
affiliation: Department of Sports Medicine, Institute of Sports Sciences, Goethe-University Frankfurt, Germany
name: Winfried Banzer, Prof
role: STUDY_DIRECTOR
References:
citation: 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.