NCT07624032

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

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

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

May 28, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

Delayed onset muscle sorenessDOMSProprioceptive neuromuscular facilitationPNFCryotherapyEccentric exerciseHamstringsBlood lactatePhysical therapyPressure pain thresholdMuscle strengthRange of motionPain intensity

Outcome Measures

Primary Outcomes (1)

  • Change in Pressure Pain Threshold in the Hamstring Muscles

    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

Secondary Outcomes (5)

  • Change in Active Knee Range of Motion

    Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise

  • Change in Hamstring Muscle Strength

    Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise

  • Change in Pain Intensity

    Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise

  • Change in Blood Lactate Concentration

    Before exercise, immediately after exercise, and 48 hours after exercise

  • Perceived Exertion After Eccentric Exercise

    Immediately after eccentric exercise

Study Arms (3)

Proprioceptive Neuromuscular Facilitation

EXPERIMENTAL

Participants received a proprioceptive neuromuscular facilitation intervention targeting the hamstring muscles 24 hours after eccentric exercise-induced delayed onset muscle soreness.

Other: Proprioceptive Neuromuscular Facilitation

Cryotherapy

EXPERIMENTAL

Participants received local cryotherapy over the hamstring muscles 24 hours after eccentric exercise-induced delayed onset muscle soreness.

Other: Local Cryotherapy

water with sugar

PLACEBO COMPARATOR

Participants received a placebo intervention consisting of water with sugar 24 hours after eccentric exercise-induced delayed onset muscle soreness.

Other: Placebo: Water With Sugar

Interventions

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.

Proprioceptive Neuromuscular Facilitation

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.

Cryotherapy

Participants consumed 200 mL of water with 5 g of dissolved sugar after the eccentric exercise protocol.

water with sugar

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca

Madrid, Madrid, 28015, Spain

Location

MeSH Terms

Conditions

Pain

Interventions

Muscle Stretching ExercisesSugars

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaCarbohydrates

Study Officials

  • Sara Perpiña Martínez, PhD

    Universidad Pontificia de Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors were masked to group allocation. Group assignment was concealed using opaque envelopes, and only the investigator responsible for administering the active intervention knew the allocated treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to one of three parallel groups: proprioceptive neuromuscular facilitation, cryotherapy, or placebo. Delayed onset muscle soreness was induced through eccentric hamstring exercises before the assigned intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator and Professor of Physiotherapy

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 3, 2026

Study Start

January 1, 2025

Primary Completion

April 26, 2025

Study Completion

April 30, 2025

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data related to the outcomes reported in the study may be shared upon reasonable request to the principal investigator. Data will only be shared for academic and research purposes, after approval by the study team, and in accordance with applicable data protection regulations.

Locations