Electromagnetic FieldsNCT05554874
Effect of Pulsed Electromagnetic Stimulation on DOMS
A study testing Pulsed electromagnetic fields in people with Electromagnetic Fields, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effect of Pulsed Electro Magnetic Field application on delayed muscle soreness in healthy Quadriceps femoris muscle. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Electromagnetic Fields
- What is being tested?
- Pulsed electromagnetic fields
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2022to 10 Mar 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- not having any systemic disease
- not having neuromuscular deficit
- not having knee pathology
- To be defined as inactive (less than 30 minutes of moderate physical activity five times a week) according to the minimum activity guidelines published by the American College of Sports Medicine
Who cannot join
- Being actively involved in any sport
- participating in a regular exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pulsed Electromagnetic Stimulation on DOMS: A Randomized Sham-controlled Trial.
The aim of our study is to investigate the effect of Pulsed Electro Magnetic Field application on delayed muscle soreness in healthy Quadriceps femoris muscle.
Read the detailed description
Participants will complete 100 consecutive fall jumps from a 0.60 m high platform to generate Delayed muscle soreness. After landing, participants will be encouraged to jump vertically immediately with maximum force. Five sets of 20 jumps will be performed with 10-second intervals between each jump, with a 2-minute rest between sets.Immediately after the implementation of the exercise protocol that will cause delayed muscle soreness, the participants will be randomly divided into 2 groups. Pulsed Electromagnetic Field or sham Pulsed Electromagnetic Field application will be applied to the non-dominant extremities of the participants.
The participants will be evaluated before (0), 24, 48 and 72 hours after the delayed muscle pain protocol.
Pain intensity of the participants will be evaluated with Visual Pain Scale (VAS), muscle fatigue will be evaluated with Modified Borg Scale, muscle performance will be evaluated with one-leg jump test, and muscle tenderness will be evaluated with an algometer.
In addition, serum creatine kinase and myoglabin values will be tested by laboratory analysis.
- Conditions
- Electromagnetic Fields
- Being tested
- Pulsed electromagnetic fields, Sham Pulsed electromagnetic fields
- Keywords
- Electromagnetic Fields, Delayed Onset muscle soreness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic fieldsOther
receiving Pulsed electromagnetic fields 3 times, immediately after the onset of delayed muscle soreness, 24 and 48 hours later.
Sham Pulsed electromagnetic fieldsOther
Sham application will be applied with the same device without applying magnetic current.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | participants undergoing pulsed electromagnetic fields Receives: Other: Pulsed electromagnetic fields |
| Control group | Sham comparator | participants undergoing sham pulsed electromagnetic fields Receives: Other: Sham Pulsed electromagnetic fields |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensty
assessed with VAS
Measured: up to 72 hours
Muscle fatigue
Borg scale
Measured: up to 72 hours
Muscle performance
Single leg hop test
Measured: up to 72 hours
Muscle tenderness
Algometer
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start10 Nov 2022
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Electromagnetic FieldsStudies 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
- Model description
- Real or sham pulsed electromagnetic fields
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Nur OYMAK SOYSAL, Pamukkale University
- Investigators
- Ummuhan Bas Aslan, Prof, Study chair, Prof Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554874
- Sponsor's protocol ID
- 17.05.2022/08
- Status last verified
- Mar 2024
- First submitted
- 16 Sep 2022
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nosaka K, Newton M, Sacco P. Delayed-onset muscle soreness does not reflect the magnitude of eccentric exercise-induced muscle damage. Scand J Med Sci Sports. 2002 Dec;12(6):337-46. doi: 10.1034/j.1600-0838.2002.10178.x.
PubMed 12453160Sellwood KL, Brukner P, Williams D, Nicol A, Hinman R. Ice-water immersion and delayed-onset muscle soreness: a randomised controlled trial. Br J Sports Med. 2007 Jun;41(6):392-7. doi: 10.1136/bjsm.2006.033985. Epub 2007 Jan 29.
PubMed 1726156211. Rasmussen, C., Rathleff, M. S., Knudsen, C., Skou, S. T., Jørgensen, M., Olesen, J., et al. (2012). Pulsed electromagnetic field therapy reduces delayed onset muscle soreness in marathon runners. In A double-blind randomized placebo-controlled study. 13th EFORT (pp. 1e18).
12. Walsh, J., Simonds, L., & Tiidus, P. (2010). Pulsed magnetic field therapy does not influence indices of muscle damage following eccentric exercise: a preliminary study. Medicine in Sport, 14(4), 199e203.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsed Electromagnetic Stimulation on DOMS: A Randomized Sham-controlled Trial.
- ClinicalTrials.gov ID
- NCT05554874
- Acronym / sponsor ID
- 17.05.2022/08
- Conditions
- Electromagnetic Fields
- Keywords
- Electromagnetic Fields, Delayed Onset muscle soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 26 Sep 2022 (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 aim of our study is to investigate the effect of Pulsed Electro Magnetic Field application on delayed muscle soreness in healthy Quadriceps femoris muscle.
Detailed description
Participants will complete 100 consecutive fall jumps from a 0.60 m high platform to generate Delayed muscle soreness. After landing, participants will be encouraged to jump vertically immediately with maximum force. Five sets of 20 jumps will be performed with 10-second intervals between each jump, with a 2-minute rest between sets.Immediately after the implementation of the exercise protocol that will cause delayed muscle soreness, the participants will be randomly divided into 2 groups. Pulsed Electromagnetic Field or sham Pulsed Electromagnetic Field application will be applied to the non-dominant extremities of the participants.
The participants will be evaluated before (0), 24, 48 and 72 hours after the delayed muscle pain protocol.
Pain intensity of the participants will be evaluated with Visual Pain Scale (VAS), muscle fatigue will be evaluated with Modified Borg Scale, muscle performance will be evaluated with one-leg jump test, and muscle tenderness will be evaluated with an algometer.
In addition, serum creatine kinase and myoglabin values will be tested by laboratory analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Real or sham pulsed electromagnetic fields
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Other: Pulsed electromagnetic fieldsparticipants undergoing pulsed electromagnetic fields |
| Control group | Sham comparator | Other: Sham Pulsed electromagnetic fieldsparticipants undergoing sham pulsed electromagnetic fields |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- not having any systemic disease
- not having neuromuscular deficit
- not having knee pathology
- To be defined as inactive (less than 30 minutes of moderate physical activity five times a week) according to the minimum activity guidelines published by the American College of Sports Medicine
Key exclusion criteria (2 listed)
- Being actively involved in any sport
- participating in a regular exercise program
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 |
|---|---|---|
| Pulsed electromagnetic fieldsreceiving Pulsed electromagnetic fields 3 times, immediately after the onset of delayed muscle soreness, 24 and 48 hours later. | Other | Case group |
| Sham Pulsed electromagnetic fieldsSham application will be applied with the same device without applying magnetic current. | Other | Control group |
Primary outcome
Pain intensty
Time frame: up to 72 hours
assessed with VAS
Muscle fatigue
Time frame: up to 72 hours
Borg scale
Muscle performance
Time frame: up to 72 hours
Single leg hop test
Muscle tenderness
Time frame: up to 72 hours
Algometer
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 7 Mar 2024.
- Background: PubMed 12453160Nosaka K, Newton M, Sacco P. Delayed-onset muscle soreness does not reflect the magnitude of eccentric exercise-induced muscle damage. Scand J Med Sci Sports. 2002 Dec;12(6):337-46. doi: 10.1034/j.1600-0838.2002.10178.x.
- Background: PubMed 17261562Sellwood KL, Brukner P, Williams D, Nicol A, Hinman R. Ice-water immersion and delayed-onset muscle soreness: a randomised controlled trial. Br J Sports Med. 2007 Jun;41(6):392-7. doi: 10.1136/bjsm.2006.033985. Epub 2007 Jan 29.
- Background11. Rasmussen, C., Rathleff, M. S., Knudsen, C., Skou, S. T., Jørgensen, M., Olesen, J., et al. (2012). Pulsed electromagnetic field therapy reduces delayed onset muscle soreness in marathon runners. In A double-blind randomized placebo-controlled study. 13th EFORT (pp. 1e18).
- Background12. Walsh, J., Simonds, L., & Tiidus, P. (2010). Pulsed magnetic field therapy does not influence indices of muscle damage following eccentric exercise: a preliminary study. Medicine in Sport, 14(4), 199e203.
- 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.
Ummuhan Bas Aslan, Prof study chair
Prof Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electromagnetic fields in people with Electromagnetic Fields, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 4 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 7 Mar 2024. 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 Turkey (Türkiye). 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 intensty (time frame: up to 72 hours). The study lists 4 primary outcomes in all. 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 NCT05554874, which also lists 4 linked publications.
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 7 Mar 2024.