The Effect of Reducing Soreness in Marathon Runners

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01512082
First received: January 10, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Contracture of Muscle, Thigh
Device: Pulsed electromagnetic field devices

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

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 47
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ActiPatch TM, Scandinavia ApS, Denmark
Sham Comparator: Non-active pulsed electromagnetic field Device: Pulsed electromagnetic field devices
Every persons received two sham pulsed electromagnetic field devices.
Other Name: ActiPatch TM, Scandinavia ApS, Denmark

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Completion of a marathon
  • Age > 18 years

Exclusion Criteria:

- Unable to read and speak Danish

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512082

Locations
Denmark
Orthopaedic Surgery Research Unit, Aalborg University Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Principal Investigator: Sten Rasmussen, M.D. Northern Orthopaedic Division, Aalborg University Hospital, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01512082     History of Changes
Other Study ID Numbers: N-20110021
Study First Received: January 10, 2012
Last Updated: March 28, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Pain
Delayed onset muscle soreness
Pulsed electromagnetic field
Marathon

Additional relevant MeSH terms:
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases

ClinicalTrials.gov processed this record on October 16, 2014