Delayed Onset Muscle Soreness (DOMS)NCT07624032
PNF Versus Cryotherapy in Delayed Onset Muscle Soreness
A study testing Proprioceptive Neuromuscular Facilitation and Local Cryotherapy in people with Delayed Onset Muscle Soreness (DOMS), run by Universidad Pontificia de Salamanca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness (DOMS)
- What is being tested?
- Proprioceptive Neuromuscular Facilitation and Local Cryotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Musculoskeletal injury of the lower limb.
- Pregnancy.
- Diabetes.
- Cardiovascular problems.
- History of cancer.
- Autoimmune diseases, including Raynaud disease or rheumatoid arthritis.
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- Sensory disorders.
- Skin disorders.
- Skin conditions.
- Peripheral venous or lymphatic vascular insufficiency.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca
Madrid, Madrid, 28015
About this study
Official title: 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.
- Conditions
- Delayed Onset Muscle Soreness (DOMS)
- Being tested
- Proprioceptive Neuromuscular Facilitation, Local Cryotherapy, Placebo: Water With Sugar
- Keywords
- Delayed onset muscle soreness, DOMS, Proprioceptive neuromuscular facilitation, PNF, Cryotherapy, Eccentric exercise, Hamstrings, Blood lactate, Physical therapy, Pressure pain threshold, Muscle strength, Range of motion, Pain intensity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular FacilitationOther
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.
Local CryotherapyOther
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: Water With SugarOther
Participants consumed 200 mL of water with 5 g of dissolved sugar after the eccentric exercise protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Proprioceptive Neuromuscular Facilitation |
| Cryotherapy | Experimental | Participants received local cryotherapy over the hamstring muscles 24 hours after eccentric exercise-induced delayed onset muscle soreness. Receives: 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. Receives: Other: Placebo: Water With Sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Active knee flexion and extension range of motion were assessed using a manual goniometer.
Measured: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
Change in Hamstring Muscle Strength
Maximum hamstring strength was assessed using a handheld dynamometer.
Measured: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
Change in Pain Intensity
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.
Measured: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
Change in Blood Lactate Concentration
Blood lactate concentration was measured using a Lactate Edge device.
Measured: Before exercise, immediately after exercise, and 48 hours after exercise
Perceived Exertion 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.
Measured: Immediately after eccentric exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jan 2025
- Primary completion26 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset Muscle Soreness (DOMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia de Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Perpiñá, Universidad Pontificia de Salamanca
- Investigators
- Sara Perpiña Martínez, PhD, Principal investigator, Universidad Pontificia de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624032
- Sponsor's protocol ID
- UPSA-DOMS-2025
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Proprioceptive Neuromuscular Facilitation Versus Cryotherapy and Placebo on Delayed Onset Muscle Soreness: A Randomized Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT07624032
- Acronym / sponsor ID
- UPSA-DOMS-2025
- Conditions
- Delayed Onset Muscle Soreness (DOMS)
- Keywords
- Delayed onset muscle soreness, DOMS, Proprioceptive neuromuscular facilitation, PNF, Cryotherapy, Eccentric exercise, Hamstrings, Blood lactate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universidad Pontificia de SalamancaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 26 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation | Experimental | Other: Proprioceptive Neuromuscular FacilitationParticipants received a proprioceptive neuromuscular facilitation intervention targeting the hamstring muscles 24 hours after eccentric exercise-induced delayed onset muscle soreness. |
| Cryotherapy | Experimental | Other: Local CryotherapyParticipants received local cryotherapy over the hamstring muscles 24 hours after eccentric exercise-induced delayed onset muscle soreness. |
| water with sugar | Placebo comparator | Other: Placebo: Water With SugarParticipants received a placebo intervention consisting of water with sugar 24 hours after eccentric exercise-induced delayed onset muscle soreness. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Musculoskeletal injury of the lower limb.
- Pregnancy.
- Diabetes.
- Cardiovascular problems.
- History of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive Neuromuscular FacilitationA 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. | Other | Proprioceptive Neuromuscular Facilitation |
| Local CryotherapyParticipants 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. | Other | Cryotherapy |
| Placebo: Water With SugarParticipants consumed 200 mL of water with 5 g of dissolved sugar after the eccentric exercise protocol. | Other | water with sugar |
Primary outcome
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
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.
5 secondary outcomes
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
Change in Hamstring Muscle Strength
Time frame: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
Change in Pain Intensity
Time frame: Baseline, 24 hours after eccentric exercise before treatment, immediately after treatment, and 48 hours after eccentric exercise
Change in Blood Lactate Concentration
Time frame: Before exercise, immediately after exercise, and 48 hours after exercise
Perceived Exertion After Eccentric Exercise
Time frame: Immediately after eccentric exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Perpiña Martínez, PhD principal investigator
Universidad Pontificia de Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation and Local Cryotherapy in people with Delayed Onset Muscle Soreness (DOMS), run by Universidad Pontificia de Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.