The Effect of Reducing Soreness in Marathon Runners

April 9, 2015 updated by: Northern Orthopaedic Division, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Orthopaedic Surgery Research Unit, Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completion of a marathon
  • Age > 18 years

Exclusion Criteria:

- Unable to read and speak Danish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active pulsed electromagnetic field
Device: Pulsed electromagnetic field devices
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.
Other Names:
  • ActiPatch TM, Scandinavia ApS, Denmark
Device: Pulsed electromagnetic field devices
Every persons received two sham pulsed electromagnetic field devices.
Other Names:
  • ActiPatch TM, Scandinavia ApS, Denmark
Sham Comparator: Non-active pulsed electromagnetic field
Device: Pulsed electromagnetic field devices
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.
Other Names:
  • ActiPatch TM, Scandinavia ApS, Denmark
Device: Pulsed electromagnetic field devices
Every persons received two sham pulsed electromagnetic field devices.
Other Names:
  • ActiPatch TM, Scandinavia ApS, Denmark

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registration of injuries and symptoms from the musculoskeletal system.
Time Frame: 5 days
The group that received active pulsed electromagnetic field was running for a significant longer time the first day following the marathon.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Investigators

  • Principal Investigator: Sten Rasmussen, M.D., Northern Orthopaedic Division, Aalborg University Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 13, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20110021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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