The Effect of Reducing Soreness in Marathon Runners

Contracture of Muscle, Thigh Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512082
• Other study ID #: N-20110021
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: April 9, 2015
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completion of a marathon

• Age > 18 years

Exclusion Criteria:

• Unable to read and speak Danish

Study Design

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

Related Conditions & MeSH terms

• Contracture
• Contracture of Muscle, Thigh

Intervention

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.
• Pulsed electromagnetic field devices
Every persons received two sham pulsed electromagnetic field devices.

Locations

Country	Name	City	State
Denmark	Orthopaedic Surgery Research Unit, Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 days	No
Secondary	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.	5 days	No