Sports Physical TherapyNCT03411278
Effect of Deep Oscillation Treatment as a Method for Recovery in Soccer
A study testing Deep Oscillation (DO) in people with Sports Physical Therapy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the effects of Deep Oscillation (DO) self-treatment on recovery after fatiguing soccer training. We investigate deep oscillation (DO) self treatment as a measure to promote regeneration, hypothesizing that DO leads to an accelerated recovery within the first 48h after fatiguing… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Deep Oscillation (DO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 12 Dec 2017to 22 Feb 2018
- 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 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- active soccer player in of the 5th devision
Who cannot join
- health problems
- medication with impact on the endpoints
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, University Erlangen-Nurnberg
Erlangen, Bavaria, 91052
About this study
Official title: Effect of Deep Oscillation Treatment as a Method for Recovery After Fatiguing Soccer Training. A Randomized Cross-Over Study
The purpose of this study is to evaluate the effects of Deep Oscillation (DO) self-treatment on recovery after fatiguing soccer training. We investigate deep oscillation (DO) self treatment as a measure to promote regeneration, hypothesizing that DO leads to an accelerated recovery within the first 48h after fatiguing training with positive effect on the maximum strength, rated perceived exertion, creatinkinase (CK) values and DOMS compared to no treatment after an .
Read the detailed description
Recovery time between in association football (soccer) often is not long enough to completely restore. Insufficient recovery can result in a reduced performance and suboptimal development in the training process and a higher risk for injuries. The purpose of this study is to evaluate the effects of Deep Oscillation (DO) self-treatment on recovery after fatiguing soccer training. Deep Oscillation is a unique method which is characterized by an alternating electrostatic which results in a deep resonance vibration of patients tissue.
Methods: In a randomized crossover study design including 10 soccer players of the 5th german devision the following parameters will be evaluated directly before and 48h after an fatiguing soccer specific exercise: Maximum isokinetic strength of the leg and hip extensors and flexors (Con-Trex® Leg Press, Physiomed, Germany), rating of perceived exertion (RPE) during isokinetic testing (Borg scale 6-20) and creatine kinase (CK) serum levels. Delayed Onset Muscle Soreness (DOMS; visual analogue scale 1-10) will be recorded 24 and 48h post-exercise. At random half of the group will perform a DO self-treatment twice daily (4 applications) for 15 minutes each, whereas the other half gets no intervention. 4 weeks later in a cross-over design the same procedure will be conducted again.
- Conditions
- Sports Physical Therapy
- Being tested
- Deep Oscillation (DO)
- Keywords
- recovery, deep oscillation, soccer, sports, training, electrotherapy, physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Oscillation (DO)Device
Also called electrostatic fields, electrotherapy
DO self treatment with the device "mobile" (Physiomed, Laipersdorf, Germany; U.S. patent 7,343,203 B2).The device produces an alternating electrostatic field, which results in a low-frequency vibration penetrating the tissue. The Field is pulsed at a frequency of 90 Hz. For self-treatment, each volunteer is given an apparatus to take home. An applicator with a diameter of 9 cm is used. The treatment will be carried out in the morning and evening for 15 minutes each in supine position on a sofa. In accordance with the technique of classical manual lymphatic drainage, stroking and circular movements in the upper and lower leg and the inguinal area take place in a fixed order.
| Study group | Role | What they receive |
|---|---|---|
| Deep Oscillation (DO) self treatment | Experimental | DO self treatment with the device "mobile" (Physiomed, Laipersdorf, Germany; U.S. patent 7,343,203 B2). The device produces an alternating electrostatic field, which results in a low-frequency vibration penetrating the tissue. The Field is pulsed at a frequency of 90 Hz. For self-treatment, each volunteer is given an apparatus to take home. An applicator with a diameter of 9 cm is used. The treatment will be carried out in the morning and evening for 15 minutes each in supine position on a sofa. In accordance with the technique of classical manual lymphatic drainage, stroking and circular movements in the upper and lower leg and the inguinal area take place in a fixed order. Receives: Device: Deep Oscillation (DO) |
| No intervention, control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic maximum leg strength
Maximum isokinetic strength of the leg- extensors and flexors is tested using a ConTrex isokinetic leg press (Physiomed, Laipers-dorf, Germany).
Measured: prae fatiguing exercise and 48hours post
Secondary outcomes (3)
Rating of perceived exertion (RPE)
Rating of perceived exertion (RPE) is obtained immediately after the maximum strength test, using Borg´s 20-point scale.
Measured: during isokinetic testing prae fatiguing exercise and 48hours post
Creatine kinase (CK)
Creatine kinase (CK) level is analysed out of the serum using the Beckmann Coulter Inc. device (Brea, USA).
Measured: prae fatiguing exercise and 48hours post
Delayed Onset Muscle Soreness (DOMS)
Self reported Delayed Onset Muscle Soreness (DOMS) in the lower extremity on the day after the training and the day after using a visual analogue scale (VAS) from 1 (no muscle soreness) to 10 (maximum muscle soreness) .
Measured: 24hours and 48hours postexercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start12 Dec 2017
- Primary completion24 Jan 2018
- Study completion22 Feb 2018
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 Sports Physical TherapyStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, cross-over, repeated measures design is used to evaluate the effects of DO on recovery. At random in study phase I the half of the group performs a DO self-treatment twice daily (4 applications) for 15 minutes each, whereas the other half gets no intervention. After a washing out period in study phase II a crossover will be performed. The same protocol is performed again, whereas the other half of the participants carries out the DO intervention .
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411278
- Sponsor's protocol ID
- IMPDO1
- Status last verified
- Feb 2018
- First submitted
- 18 Jan 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
von Stengel S, Teschler M, Weissenfels A, Willert S, Kemmler W. Effect of deep oscillation as a recovery method after fatiguing soccer training: A randomized cross-over study. J Exerc Sci Fit. 2018 Dec;16(3):112-117. doi: 10.1016/j.jesf.2018.10.004. Epub 2018 Oct 16.
PubMed 30662504
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Oscillation Treatment as a Method for Recovery After Fatiguing Soccer Training. A Randomized Cross-Over Study
- ClinicalTrials.gov ID
- NCT03411278
- Acronym / sponsor ID
- IMPDO1
- Conditions
- Sports Physical Therapy
- Keywords
- recovery, deep oscillation, soccer, sports, training, electrotherapy, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 26 Jan 2018 (actual)
- 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 purpose of this study is to evaluate the effects of Deep Oscillation (DO) self-treatment on recovery after fatiguing soccer training. We investigate deep oscillation (DO) self treatment as a measure to promote regeneration, hypothesizing that DO leads to an accelerated recovery within the first 48h after fatiguing training with positive effect on the maximum strength, rated perceived exertion, creatinkinase (CK) values and DOMS compared to no treatment after an .
Detailed description
Recovery time between in association football (soccer) often is not long enough to completely restore. Insufficient recovery can result in a reduced performance and suboptimal development in the training process and a higher risk for injuries. The purpose of this study is to evaluate the effects of Deep Oscillation (DO) self-treatment on recovery after fatiguing soccer training. Deep Oscillation is a unique method which is characterized by an alternating electrostatic which results in a deep resonance vibration of patients tissue.
Methods: In a randomized crossover study design including 10 soccer players of the 5th german devision the following parameters will be evaluated directly before and 48h after an fatiguing soccer specific exercise: Maximum isokinetic strength of the leg and hip extensors and flexors (Con-Trex® Leg Press, Physiomed, Germany), rating of perceived exertion (RPE) during isokinetic testing (Borg scale 6-20) and creatine kinase (CK) serum levels. Delayed Onset Muscle Soreness (DOMS; visual analogue scale 1-10) will be recorded 24 and 48h post-exercise. At random half of the group will perform a DO self-treatment twice daily (4 applications) for 15 minutes each, whereas the other half gets no intervention. 4 weeks later in a cross-over design the same procedure will be conducted again.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, cross-over, repeated measures design is used to evaluate the effects of DO on recovery. At random in study phase I the half of the group performs a DO self-treatment twice daily (4 applications) for 15 minutes each, whereas the other half gets no intervention. After a washing out period in study phase II a crossover will be performed. The same protocol is performed again, whereas the other half of the participants carries out the DO intervention .
| Arm | Type | Receives |
|---|---|---|
| Deep Oscillation (DO) self treatment | Experimental | Device: Deep Oscillation (DO)DO self treatment with the device "mobile" (Physiomed, Laipersdorf, Germany; U.S. patent 7,343,203 B2). The device produces an alternating electrostatic field, which results in a low-frequency vibration penetrating the tissue. The Field is pulsed at a frequency of 90 Hz. For self-treatment, each volunteer is given an apparatus to take home. An applicator with a diameter of 9 cm is used. The treatment will be carried out in the morning and evening for 15 minutes each in supine position on a sofa. In accordance with the technique of classical manual lymphatic drainage, stroking and circular movements in the upper and lower leg and the inguinal area take place in a fixed order. |
| No intervention, control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- active soccer player in of the 5th devision
Key exclusion criteria (2 listed)
- health problems
- medication with impact on the endpoints
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 |
|---|---|---|
| Deep Oscillation (DO)Also: electrostatic fields, electrotherapyDO self treatment with the device "mobile" (Physiomed, Laipersdorf, Germany; U.S. patent 7,343,203 B2).The device produces an alternating electrostatic field, which results in a low-frequency vibration penetrating the tissue. The Field is pulsed at a frequency of 90 Hz. For self-treatment, each volunteer is given an apparatus to take home. An applicator with a diameter of 9 cm is used. The treatment will be carried out in the morning and evening for 15 minutes each in supine position on a sofa. In accordance with the technique of classical manual lymphatic drainage, stroking and circular movements in the upper and lower leg and the inguinal area take place in a fixed order. | Device | Deep Oscillation (DO) self treatment |
Primary outcome
Isokinetic maximum leg strength
Time frame: prae fatiguing exercise and 48hours post
Maximum isokinetic strength of the leg- extensors and flexors is tested using a ConTrex isokinetic leg press (Physiomed, Laipers-dorf, Germany).
3 secondary outcomes
Rating of perceived exertion (RPE)
Time frame: during isokinetic testing prae fatiguing exercise and 48hours post
Creatine kinase (CK)
Time frame: prae fatiguing exercise and 48hours post
Delayed Onset Muscle Soreness (DOMS)
Time frame: 24hours and 48hours postexercise
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 23 Feb 2018.
- Derived from this study: PubMed 30662504von Stengel S, Teschler M, Weissenfels A, Willert S, Kemmler W. Effect of deep oscillation as a recovery method after fatiguing soccer training: A randomized cross-over study. J Exerc Sci Fit. 2018 Dec;16(3):112-117. doi: 10.1016/j.jesf.2018.10.004. Epub 2018 Oct 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Oscillation (DO) in people with Sports Physical Therapy, run by University of Erlangen-Nürnberg Medical School 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 1 inclusion and 2 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 23 Feb 2018. 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. 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?
Isokinetic maximum leg strength (time frame: prae fatiguing exercise and 48hours post). 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 NCT03411278, 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 23 Feb 2018.