Contracture of Muscle, ThighNCT01512082
The Effect of Reducing Soreness in Marathon Runners
A study testing Pulsed electromagnetic field devices in people with Contracture of Muscle, Thigh, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Delayed onset muscle soreness is defined as the sensition of pain and discomfort in skeletal muscles that occurs after eccentric muscle actions or strenuous exercise like a marathon. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contracture of Muscle, Thigh
- What is being tested?
- Pulsed electromagnetic field devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to May 2012
- 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
- Completion of a marathon
- Age > 18 years
Who cannot join
- Unable to read and speak Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Surgery Research Unit, Aalborg University Hospital
Aalborg, 9000
About this study
Official title: The Effect of Pulsed Electromagnetic Field Therapy in Reducing Delayed Onset Muscle Soreness in Marathon Runners. A Double-blind Randomized Placebo-controlled Study.
Delayed onset muscle soreness is defined as the sensition of pain and discomfort in skeletal muscles that occurs after eccentric muscle actions or strenuous exercise like a marathon.
Read the detailed description
There is a growing body of clinical evidence which shows that noninvasive, nonpharmacologic pulsed electromagnetic fields have many clinical effects. Pulsed electromagnetic fields have shown to reduce pain in different groups of patients. This concerns patients with osteoarthritis, rheumatoid arthritis, diabetic neuropathy, fibromyalgia, distal radius fractures, pelvic pain and postoperative patients.
A marathon is a muscular strain. Physiologic effects of a marathon involves muscular and connective tissue damage which initiates an inflammatory response as well as release of metabolic factors like lactate and free radicals, intracellular metabolites and by-products of proteolysis.
The objective of this study was to investigate the efficacy of pulsed electromagnetic fields compared to placebo in reducing delayed onset muscle soreness in marathon runners.
- Conditions
- Contracture of Muscle, Thigh
- Being tested
- Pulsed electromagnetic field devices
- Keywords
- Pain, Delayed onset muscle soreness, Pulsed electromagnetic field, Marathon
- Medical subject headings
- Contracture, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic field devicesDevice
Also called ActiPatch TM, Scandinavia ApS, Denmark
Every person received two active devices. The devices emitted 2-ms bursts of 27.12 MHz sinusoidal waves repeating at 2 bursts/s. Peak magnetic field intensity was 0.05 G which induced an average electric field of 10 mV in the tissue with an effect of 7.3 mW/cm3.
Pulsed electromagnetic field devicesDevice
Also called ActiPatch TM, Scandinavia ApS, Denmark
Every persons received two sham pulsed electromagnetic field devices.
| Study group | Role | What they receive |
|---|---|---|
| Active pulsed electromagnetic field | Experimental | Not described Receives: Device: Pulsed electromagnetic field devices |
| Non-active pulsed electromagnetic field | Sham comparator | Not described Receives: Device: Pulsed electromagnetic field devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh pain by walking
Primary outcome of thigh pain during semi-squat during 5 days following the marathon showed a significantly lower pain among the active group compared to the placebo group.
The outcome was thigh muscle pain measured on a 10 cm visual analog scale during a squat of 90 degrees three times a day; when they woke up, at 12 pm and 8 pm.
Measured: 5 days
Secondary outcomes (1)
Registration of injuries and symptoms from the musculoskeletal system.
The group that received active pulsed electromagnetic field was running for a significant longer time the first day following the marathon.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contracture of Muscle, ThighStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D., Principal investigator, Northern Orthopaedic Division, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512082
- Sponsor's protocol ID
- N-20110021
- Status last verified
- Apr 2015
- First submitted
- 10 Jan 2012
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulsed Electromagnetic Field Therapy in Reducing Delayed Onset Muscle Soreness in Marathon Runners. A Double-blind Randomized Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT01512082
- Acronym / sponsor ID
- N-20110021
- Conditions
- Contracture of Muscle, Thigh
- Keywords
- Pain, Delayed onset muscle soreness, Pulsed electromagnetic field, Marathon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Jan 2012 (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.
Delayed onset muscle soreness is defined as the sensition of pain and discomfort in skeletal muscles that occurs after eccentric muscle actions or strenuous exercise like a marathon.
Detailed description
There is a growing body of clinical evidence which shows that noninvasive, nonpharmacologic pulsed electromagnetic fields have many clinical effects. Pulsed electromagnetic fields have shown to reduce pain in different groups of patients. This concerns patients with osteoarthritis, rheumatoid arthritis, diabetic neuropathy, fibromyalgia, distal radius fractures, pelvic pain and postoperative patients.
A marathon is a muscular strain. Physiologic effects of a marathon involves muscular and connective tissue damage which initiates an inflammatory response as well as release of metabolic factors like lactate and free radicals, intracellular metabolites and by-products of proteolysis.
The objective of this study was to investigate the efficacy of pulsed electromagnetic fields compared to placebo in reducing delayed onset muscle soreness in marathon runners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active pulsed electromagnetic field | Experimental | Device: Pulsed electromagnetic field devices |
| Non-active pulsed electromagnetic field | Sham comparator | Device: Pulsed electromagnetic field devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completion of a marathon
- Age > 18 years
Key exclusion criteria (1 listed)
- Unable to read and speak Danish
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 field devicesAlso: ActiPatch TM, Scandinavia ApS, DenmarkEvery person received two active devices. The devices emitted 2-ms bursts of 27.12 MHz sinusoidal waves repeating at 2 bursts/s. Peak magnetic field intensity was 0.05 G which induced an average electric field of 10 mV in the tissue with an effect of 7.3 mW/cm3. | Device | Active pulsed electromagnetic field |
| Pulsed electromagnetic field devicesAlso: ActiPatch TM, Scandinavia ApS, DenmarkEvery persons received two sham pulsed electromagnetic field devices. | Device | Non-active pulsed electromagnetic field |
Primary outcome
Thigh pain by walking
Time frame: 5 days
Primary outcome of thigh pain during semi-squat during 5 days following the marathon showed a significantly lower pain among the active group compared to the placebo group. The outcome was thigh muscle pain measured on a 10 cm visual analog scale during a squat of 90 degrees three times a day; when they woke up, at 12 pm and 8 pm.
1 secondary outcome
Registration of injuries and symptoms from the musculoskeletal system.
Time frame: 5 days
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 10 Apr 2015.
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.
Sten Rasmussen, M.D. principal investigator
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
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 field devices in people with Contracture of Muscle, Thigh, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 2 inclusion and 1 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 10 Apr 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 Denmark. 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?
Thigh pain by walking (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2015.