The Effect of Reducing Soreness in Marathon Runners

This study is currently recruiting participants.

Verified May 2013 by Northern Orthopaedic Division, Denmark

Sponsor:

Information provided by (Responsible Party):

Northern Orthopaedic Division, Denmark

ClinicalTrials.gov Identifier:

NCT01512082

First received: January 10, 2012

Last updated: May 1, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 10, 2012

Last Updated Date

May 1, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Thigh pain by walking [ Time Frame: 5 days ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01512082 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Registration of injuries and symptoms from the musculoskeletal system. [ Time Frame: 5 days ] [ Designated as safety issue: No ]

The group that received active pulsed electromagnetic field was running for a significant longer time the first day following the marathon.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Reducing Soreness in Marathon Runners

Official Title ^ICMJE

The Effect of Pulsed Electromagnetic Field Therapy in Reducing Delayed Onset Muscle Soreness in Marathon Runners. A Double-blind Randomized Placebo-controlled Study.

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Contracture of Muscle, Thigh

Intervention ^ICMJE

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 Name: ActiPatch TM, Scandinavia ApS, Denmark
Device: Pulsed electromagnetic field devices
Every persons received two sham pulsed electromagnetic field devices.

Other Name: ActiPatch TM, Scandinavia ApS, Denmark

Study Arm (s)

Experimental: Active pulsed electromagnetic field
Intervention: Device: Pulsed electromagnetic field devices
Sham Comparator: Non-active pulsed electromagnetic field
Intervention: Device: Pulsed electromagnetic field devices

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Completion of a marathon
Age > 18 years

Exclusion Criteria:

- Unable to read and speak Danish

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Sten Rasmussen, M.D.

sten.rasmussen@rn.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01512082

Other Study ID Numbers ^ICMJE

N-20110021

Has Data Monitoring Committee

Responsible Party

Northern Orthopaedic Division, Denmark

Study Sponsor ^ICMJE

Northern Orthopaedic Division, Denmark

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sten Rasmussen, M.D.

Northern Orthopaedic Division, Aalborg University Hospital, Denmark

Information Provided By

Northern Orthopaedic Division, Denmark

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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