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

Primary Purpose

Musculoskeletal Pain, Athletic Injuries

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Verum focused extracorporeal shockwave
Sham shock wave
Sponsored by
Dr. Johannes Fleckenstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

No Intervention

Arm Label

Verum focused extracorporeal shockwave therapy

Sham shock wave

Control

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Maximum isometric voluntary force MIVF
MIVF is easured using a strain-gauge force transducer (ASYS® SPOREG, Offenbach, Germany). Peak strength values (N) are recorded.
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.

Full Information

First Posted
September 9, 2015
Last Updated
September 11, 2015
Sponsor
Dr. Johannes Fleckenstein
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1. Study Identification

Unique Protocol Identification Number
NCT02548208
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Johannes Fleckenstein

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Athletic Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum focused extracorporeal shockwave therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham shock wave
Arm Type
Sham Comparator
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control procedure stipulates participants to lay down on the same therapy table for 5 minutes receiving no intervention.
Intervention Type
Device
Intervention Name(s)
Verum focused extracorporeal shockwave
Other Intervention Name(s)
focused extracorporeal shockwave therapy
Intervention Description
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
Intervention Name(s)
Sham shock wave
Intervention 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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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).
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Pressure pain threshold (PPT)
Description
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).
Time Frame
72 hours
Title
Maximum isometric voluntary force MIVF
Description
MIVF is easured using a strain-gauge force transducer (ASYS® SPOREG, Offenbach, Germany). Peak strength values (N) are recorded.
Time Frame
72 hours
Title
Activities of daily living (ADL)
Description
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Banzer, Prof
Organizational Affiliation
Department of Sports Medicine, Institute of Sports Sciences, Goethe-University Frankfurt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Department of Sports Medicine, Institute of Sports Sciences, Goethe University
City
Frankfurt am Main
ZIP/Postal Code
60487
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27993588
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.
Results Reference
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Single Focused Shock Wave in the Release od Delayed Onset Muscle Soreness (DOMS)

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