The Effect of Reducing Soreness in Marathon Runners

NCT ID: NCT01512082

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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

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Contracture of Muscle, Thigh

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active pulsed electromagnetic field

Group Type EXPERIMENTAL

Pulsed electromagnetic field devices

Intervention Type DEVICE

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.

Non-active pulsed electromagnetic field

Group Type SHAM_COMPARATOR

Pulsed electromagnetic field devices

Intervention Type DEVICE

Every persons received two sham pulsed electromagnetic field devices.

Interventions

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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.

Intervention Type DEVICE

Pulsed electromagnetic field devices

Every persons received two sham pulsed electromagnetic field devices.

Intervention Type DEVICE

Other Intervention Names

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ActiPatch TM, Scandinavia ApS, Denmark ActiPatch TM, Scandinavia ApS, Denmark

Eligibility Criteria

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Inclusion Criteria

* Completion of a marathon
* Age \> 18 years

Exclusion Criteria

\- Unable to read and speak Danish
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sten Rasmussen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northern Orthopaedic Division, Aalborg University Hospital, Denmark

Locations

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Orthopaedic Surgery Research Unit, Aalborg University Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20110021

Identifier Type: -

Identifier Source: org_study_id

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