- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid
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Madrid, Madrid, Spain, 28015
- Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Proprioceptive Neuromuscular Facilitation
Participants received a proprioceptive neuromuscular facilitation intervention targeting the hamstring muscles 24 hours after eccentric exercise-induced delayed onset muscle soreness.
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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.
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|
Experimental: Cryotherapy
Participants received local cryotherapy over the hamstring muscles 24 hours after eccentric exercise-induced delayed onset muscle soreness.
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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.
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Placebo Comparator: water with sugar
Participants received a placebo intervention consisting of water with sugar 24 hours after eccentric exercise-induced delayed onset muscle soreness.
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Participants consumed 200 mL of water with 5 g of dissolved sugar after the eccentric exercise protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pressure Pain Threshold in the Hamstring Muscles
Time Frame: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
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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.
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Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Active Knee Range of Motion
Time Frame: 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.
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Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
|
|
Change in Hamstring Muscle Strength
Time Frame: 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
|
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Change in Blood Lactate Concentration
Time Frame: Before exercise, immediately after exercise, and 48 hours after exercise
|
Blood lactate concentration was measured using a Lactate Edge device.
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Before exercise, immediately after exercise, and 48 hours after exercise
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Change in Pain Intensity
Time Frame: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
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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.
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Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
|
|
Perceived Exertion After Eccentric Exercise
Time Frame: Immediately after eccentric exercise
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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.
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Immediately after eccentric exercise
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sara Perpiña Martínez, PhD, Universidad Pontificia de Salamanca
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Carbohydrates
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise
- Sugars
- Muscle Stretching Exercises
Other Study ID Numbers
- UPSA-DOMS-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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