Athletic Injuries, Musculoskeletal Pain
Conditions
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.
Interventions
DEVICEVerum 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.
DEVICESham 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.
Sponsors
Dr. Johannes Fleckenstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed