- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07624032
PNF Versus Cryotherapy in Delayed Onset Muscle Soreness
Efficacy of Proprioceptive Neuromuscular Facilitation Versus Cryotherapy and Placebo on Delayed Onset Muscle Soreness: A Randomized Pilot Clinical Trial
This randomized, double-blind, single-center pilot clinical trial evaluated three interventions for delayed onset muscle soreness in the hamstring muscles.
Twenty-nine untrained adults were included. Delayed onset muscle soreness was induced using two eccentric hamstring exercises. Participants were then assigned to one of three groups: proprioceptive neuromuscular facilitation, local cryotherapy, or placebo consisting of water with sugar.
The main outcome was pressure pain threshold in the hamstring muscles. Other outcomes included knee range of motion, hamstring strength, pain intensity, perceived exertion, and blood lactate levels. Measurements were taken before the eccentric exercise, 24 hours after exercise before treatment, immediately after treatment, and 48 hours after exercise.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Madrid
-
Madrid, Madrid, Spanje, 28015
- Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Adults aged between 18 and 45 years.
- Participants who did not usually perform physical exercise or whose exercise was not focused on the lower limbs.
- Participants who had previously experienced delayed onset muscle soreness and were familiar with its effects.
Exclusion Criteria:
- Musculoskeletal injury of the lower limb.
- Pregnancy.
- Diabetes.
- Cardiovascular problems.
- History of cancer.
- Autoimmune diseases, including Raynaud disease or rheumatoid arthritis.
- Sensory disorders.
- Skin disorders.
- Skin conditions.
- Peripheral venous or lymphatic vascular insufficiency.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Proprioceptive Neuromuscular Facilitation
Participants received a proprioceptive neuromuscular facilitation intervention targeting the hamstring muscles 24 hours after eccentric exercise-induced delayed onset muscle soreness.
|
A contract-relax-antagonist-contract proprioceptive neuromuscular facilitation technique was applied to the hamstring muscles.
The protocol included isometric hamstring contraction, rest, quadriceps contraction, and passive movement into a deeper hamstring stretch.
The protocol was repeated twice on each leg.
|
|
Experimenteel: Cryotherapy
Participants received local cryotherapy over the hamstring muscles 24 hours after eccentric exercise-induced delayed onset muscle soreness.
|
Participants were placed in prone position and an ice pack was applied over the hamstring muscles for 20 minutes.
A thin cloth was placed between the ice pack and the skin to avoid direct contact.
|
|
Placebo-vergelijker: water with sugar
Participants received a placebo intervention consisting of water with sugar 24 hours after eccentric exercise-induced delayed onset muscle soreness.
|
Participants consumed 200 mL of water with 5 g of dissolved sugar after the eccentric exercise protocol.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Pressure Pain Threshold in the Hamstring Muscles
Tijdsspanne: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
|
Pressure pain threshold was assessed using a pressure algometer over three points of maximum pain in the hamstring muscles.
Three measurements were taken and the mean value was calculated.
|
Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Active Knee Range of Motion
Tijdsspanne: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
|
Active knee flexion and extension range of motion were assessed using a manual goniometer.
|
Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
|
|
Change in Hamstring Muscle Strength
Tijdsspanne: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
|
Maximum hamstring strength was assessed using a handheld dynamometer.
|
Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
|
|
Change in Blood Lactate Concentration
Tijdsspanne: Before exercise, immediately after exercise, and 48 hours after exercise
|
Blood lactate concentration was measured using a Lactate Edge device.
|
Before exercise, immediately after exercise, and 48 hours after exercise
|
|
Change in Pain Intensity
Tijdsspanne: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
|
Pain intensity was assessed using the 11-point Numeric Pain Rating Scale.
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity and therefore a worse outcome.
|
Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
|
|
Perceived Exertion After Eccentric Exercise
Tijdsspanne: Immediately after eccentric exercise
|
Perceived exertion was assessed using the Modified Borg Rating of Perceived Exertion Scale after completion of the eccentric exercise protocol.
Scores range from 0 to 10, where 0 indicates no exertion and 10 indicates maximal exertion.
Higher scores indicate greater perceived exertion and therefore a worse outcome.
|
Immediately after eccentric exercise
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Sara Perpiña Martínez, PhD, Universidad Pontificia de Salamanca
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Pijn
- Motorische activiteit
- Beweging
- Musculoskeletale fysiologische fenomenen
- Musculoskeletale en neurale fysiologische fenomenen
- Therapeutica
- Modaliteiten fysiotherapie
- Koolhydraten
- Patiëntenzorg
- Transporttherapie
- Revalidatie
- Nazorg
- Continuïteit van patiëntenzorg
- Oefening
- Suikers
- Spier stretching oefeningen
Andere studie-ID-nummers
- UPSA-DOMS-2025
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .