- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01512082
The Effect of Reducing Soreness in Marathon Runners
The Effect of Pulsed Electromagnetic Field Therapy in Reducing Delayed Onset Muscle Soreness in Marathon Runners. A Double-blind Randomized Placebo-controlled Study.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Aalborg, Danmark, 9000
- Orthopaedic Surgery Research Unit, Aalborg University Hospital
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Completion of a marathon
- Age > 18 years
Exclusion Criteria:
- Unable to read and speak Danish
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Active pulsed electromagnetic field
|
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.
Andra namn:
Every persons received two sham pulsed electromagnetic field devices.
Andra namn:
|
|
Sham Comparator: Non-active pulsed electromagnetic field
|
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.
Andra namn:
Every persons received two sham pulsed electromagnetic field devices.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Thigh pain by walking
Tidsram: 5 days
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Registration of injuries and symptoms from the musculoskeletal system.
Tidsram: 5 days
|
The group that received active pulsed electromagnetic field was running for a significant longer time the first day following the marathon.
|
5 days
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Sten Rasmussen, M.D., Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- N-20110021
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