Musculoskeletal PainNCT02548208
Single Focused Shock Wave in the Release od Delayed Onset Muscle Soreness (DOMS)
A study testing Verum focused extracorporeal shockwave in people with Musculoskeletal Pain and Athletic Injuries, run by Dr. Johannes Fleckenstein at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Athletic Injuries
- What is being tested?
- Verum focused extracorporeal shockwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
- age 18+
- voluntariness
Who cannot join
- pain
- pregnancy
- musculoskeletal disease
- systemic neurological disease
- cancer
- coagulation disorder
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Sports Medicine, Institute of Sports Sciences, Goethe University
Frankfurt am Main, 60487
About this study
Official title: Effect of a Single Administration of Focused Extracorporeal Shock Wave in the Relief of Delayed-Onset Muscle Soreness
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.
Read the 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
- Being tested
- Verum focused extracorporeal shockwave, Sham shock wave
- Medical subject headings
- Musculoskeletal Pain, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum focused extracorporeal shockwaveDevice
Also called focused extracorporeal shockwave therapy
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 waveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Verum focused extracorporeal shockwave therapy | Active comparator | 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. Receives: Device: Verum focused extracorporeal shockwave |
| Sham shock wave | Sham comparator | 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. Receives: Device: Sham shock wave |
| Control | No intervention | Control procedure stipulates participants to lay down on the same therapy table for 5 minutes receiving no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 72 hours
Secondary outcomes (3)
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).
Measured: 72 hours
Maximum isometric voluntary force MIVF
MIVF is easured using a strain-gauge force transducer (ASYS® SPOREG, Offenbach, Germany). Peak strength values (N) are recorded.
Measured: 72 hours
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Johannes Fleckenstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Johannes Fleckenstein, Goethe University
- Investigators
- Winfried Banzer, Prof, Study director, Department of Sports Medicine, Institute of Sports Sciences, Goethe-University Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548208
- Sponsor's protocol ID
- ESWT_DOMS
- Status last verified
- Sep 2015
- First submitted
- 9 Sep 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27993588
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Administration of Focused Extracorporeal Shock Wave in the Relief of Delayed-Onset Muscle Soreness
- ClinicalTrials.gov ID
- NCT02548208
- Acronym / sponsor ID
- ESWT_DOMS
- Conditions
- Musculoskeletal Pain, Athletic Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Dr. Johannes FleckensteinUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verum focused extracorporeal shockwave therapy | Active comparator | Device: Verum focused extracorporeal shockwaveVerum 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 | Sham comparator | Device: Sham shock waveSham 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 | No intervention | –Control procedure stipulates participants to lay down on the same therapy table for 5 minutes receiving no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy subjects
- age 18+
- voluntariness
Key exclusion criteria (17 listed)
- pain
- pregnancy
- musculoskeletal disease
- systemic neurological disease
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum focused extracorporeal shockwaveAlso: focused extracorporeal shockwave therapythe 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. | Device | Verum focused extracorporeal shockwave therapy |
| Sham shock waveSham 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. | Device | Sham shock wave |
Primary outcome
Pain intensity
Time frame: 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).
3 secondary outcomes
Pressure pain threshold (PPT)
Time frame: 72 hours
Maximum isometric voluntary force MIVF
Time frame: 72 hours
Activities of daily living (ADL)
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
- Derived from this study: PubMed 27993588Fleckenstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Banzer, Prof study director
Department of Sports Medicine, Institute of Sports Sciences, Goethe-University Frankfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum focused extracorporeal shockwave in people with Musculoskeletal Pain and Athletic Injuries, run by Dr. Johannes Fleckenstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02548208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2015.