The Effect of Reducing Soreness in Marathon Runners
Primary Purpose
Contracture of Muscle, Thigh
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pulsed electromagnetic field devices
Pulsed electromagnetic field devices
Sponsored by
About this trial
This is an interventional treatment trial for Contracture of Muscle, Thigh focused on measuring Pain, Delayed onset muscle soreness, Pulsed electromagnetic field, Marathon
Eligibility Criteria
Inclusion Criteria:
- Completion of a marathon
- Age > 18 years
Exclusion Criteria:
- Unable to read and speak Danish
Sites / Locations
- Orthopaedic Surgery Research Unit, Aalborg University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active pulsed electromagnetic field
Non-active pulsed electromagnetic field
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01512082
First Posted
January 10, 2012
Last Updated
April 9, 2015
Sponsor
Northern Orthopaedic Division, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01512082
Brief Title
The Effect of Reducing Soreness in Marathon Runners
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contracture of Muscle, Thigh
Keywords
Pain, Delayed onset muscle soreness, Pulsed electromagnetic field, Marathon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active pulsed electromagnetic field
Arm Type
Experimental
Arm Title
Non-active pulsed electromagnetic field
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Pulsed electromagnetic field devices
Other Intervention Name(s)
ActiPatch TM, Scandinavia ApS, Denmark
Intervention Description
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
Intervention Name(s)
Pulsed electromagnetic field devices
Other Intervention Name(s)
ActiPatch TM, Scandinavia ApS, Denmark
Intervention Description
Every persons received two sham pulsed electromagnetic field devices.
Primary Outcome Measure Information:
Title
Thigh pain by walking
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Registration of injuries and symptoms from the musculoskeletal system.
Description
The group that received active pulsed electromagnetic field was running for a significant longer time the first day following the marathon.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Completion of a marathon
Age > 18 years
Exclusion Criteria:
- Unable to read and speak Danish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sten Rasmussen, M.D.
Organizational Affiliation
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Surgery Research Unit, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
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The Effect of Reducing Soreness in Marathon Runners
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