NCT01512082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

January 10, 2012

Last Update Submit

April 9, 2015

Conditions

Contracture of Muscle, Thigh

Keywords

PainDelayed onset muscle sorenessPulsed electromagnetic fieldMarathon

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Registration of injuries and symptoms from the musculoskeletal system.

    5 days

Study Arms (2)

Active pulsed electromagnetic field

EXPERIMENTAL
Device: Pulsed electromagnetic field devices

Non-active pulsed electromagnetic field

SHAM COMPARATOR
Device: Pulsed electromagnetic field devices

Interventions

Pulsed electromagnetic field devicesDEVICE

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.

Also known as: ActiPatch TM, Scandinavia ApS, Denmark
Active pulsed electromagnetic field

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completion of a marathon
  • Age \> 18 years

You may not qualify if:

  • \- Unable to read and speak Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Surgery Research Unit, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

ContracturePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesMuscular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sten Rasmussen, M.D.

    Northern Orthopaedic Division, Aalborg University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 19, 2012

Study Start

August 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

DK(1)