Muscle SorenessNCT06433856
Neuromuscular Responses to Recovery Techniques
A study testing Cold Water Immersion and Percussive Massage Therapy in people with Muscle Soreness, run by University of Trieste at 1 site in Italy.
Trial summary
Cold water immersion (CWI) and percussive massage therapy (PMT) are commonly used re-covery techniques in team sports. In particular, despite its wide use, PMT has been scarcely investigated in the literature, especially regarding neuromuscular measures and in comparison with other techniques. Read more about this study
- Who is it for?
- Ages 16 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness
- What is being tested?
- Cold Water Immersion and Percussive Massage Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 31 Jul 2023
- 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 16 to 30 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- being healthy
- training in soccer for more than 3 years and with a training frequency > 2 times/week
Who cannot join
- reported time-loss injuries
- using analgesics or other therapies affecting muscle function or pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cold Water Immersion and Percussive Gun Massage on Recovery Measures in Soccer Players
Cold water immersion (CWI) and percussive massage therapy (PMT) are commonly used re-covery techniques in team sports. In particular, despite its wide use, PMT has been scarcely investigated in the literature, especially regarding neuromuscular measures and in comparison with other techniques. This study aims to evaluate and compare the acute and short-term ef-fects (24 h) of CWI and PMT on muscle strength, contractile properties, and soreness after exercise. A randomized crossover study will be performed on sixteen male soccer players (22 y, 20-27) who participate in three experimental sessions involving high-intensity training and 12-min recovery including CWI (10 °C water), bilateral PMT on the anterior and posterior thigh, or passive resting. Outcomes will be assessed immediately after the exercise protocol, after the recovery intervention, and at 24 h. Isometric knee extension (IKE) and flexion (IKF), and tensiomyography (TMG) will be assessed.Muscle soreness and fatigue will be scored from 0 to 10.
Read the detailed description
Participants will be invited to participate to a cross-over randomized trial, consisting in 3 experimental sessions at 7 days of distance one from another. During each experimental session, participants will be asked to train for about 45 min at a high-intensity protocol (High-Intensity Intermittent Running, plyometric jumps and isometric chair position). After the exercise, participants will be assessed for neuromuscular function (isometric strength and tensiomyography) as well as perceived soreness and fatigue. Then, in a randomized order, participants will receive three different recovery interventions: cold water immersion, percussive massage, or a passive control condition. After the recovery intervention, outcomes are assessed again, as well as at 24 h. Isometric strength is assessed with a dynamometer during knee extension and knee flexion. Tensiomyography is performed on the thigh muscles, and time to contraction and radial displacement are considered as outcomes. Soreness and fatigue are rated by the participant from 0 to 10.
- Conditions
- Muscle Soreness
- Being tested
- Cold Water Immersion, Percussive Massage Therapy
- Keywords
- recovery, team sport, cryotherapy, massage guns
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Water ImmersionOther
Cold water immersion consists in 12 min standing in 10 °C water
Percussive Massage TherapyDevice
Percussive massage therapy is performed with a massage gun on the thigh muscles for 12 min
| Study group | Role | What they receive |
|---|---|---|
| CWI | Experimental | The CWI protocol consists of participants standing, with only their underwear and a t-shirt, in a portable tub for cold water therapy (Qryo, Italy), with the water to their hips being constantly maintained at 10±0.5 °C by a cooling system that pumped and stirred the water inside the tub and around the participant's lower limbs. Water temperature and the duration of the immersion, which is 12 minutes for all the participants considering they were characterized by similar anthropometrics and body composition, were based on previous literature Receives: Other: Cold Water Immersion |
| PMT | Experimental | The PMT protocol is performed with the application of a percussive therapy gun (Theragun Elite, Therabody, USA). The participants rests with their underwear and a t-shirt on a treatment bed, and the percussive therapy gun with a "standard ball", 16 mm amplitude of percussions, and a frequency of 30 Hz, is applied to the thigh muscles of both lower limbs, 3 min on the anterior and 3 min on the posterior area of each thigh. The protocol is based on previous literature and adapted to the specific aims of this study. Receives: Device: Percussive Massage Therapy |
| PAS | No intervention | The control condition (PAS) consists of participants resting on a chair for 12 minutes in a quiet room at 25 °C. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle soreness
Subjective evalutation of muscle soreness from 0 to 10 with a numeric rating scale (NRS), where 0 is no soreness at all, and 10 is unbearable soreness
Measured: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Muscle fatigue
Subjective evaluation of muscle fatigue from 0 to 10 with a numeric rating scale (NRS), where 0 is no fatigue at all, and 10 is unbearable fatigue
Measured: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Secondary outcomes (2)
Isometric muscle strength
Isometric knee extension (IKE) and flexion (IKF) strength assessments performed on a treatment bed, with a digital handheld dynamometer
Measured: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Tensiomyography
Tensiomyography (TMG) will be performed on anterior and posterior thigh muscles
Measured: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 May 2023
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SorenessStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Buoite Stella, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433856
- Sponsor's protocol ID
- Fisioterapia1705
- Status last verified
- Jun 2024
- First submitted
- 17 May 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cold Water Immersion and Percussive Gun Massage on Recovery Measures in Soccer Players
- ClinicalTrials.gov ID
- NCT06433856
- Acronym / sponsor ID
- Fisioterapia1705
- Conditions
- Muscle Soreness
- Keywords
- recovery, team sport, cryotherapy, massage guns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 30 May 2024 (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.
Cold water immersion (CWI) and percussive massage therapy (PMT) are commonly used re-covery techniques in team sports. In particular, despite its wide use, PMT has been scarcely investigated in the literature, especially regarding neuromuscular measures and in comparison with other techniques. This study aims to evaluate and compare the acute and short-term ef-fects (24 h) of CWI and PMT on muscle strength, contractile properties, and soreness after exercise. A randomized crossover study will be performed on sixteen male soccer players (22 y, 20-27) who participate in three experimental sessions involving high-intensity training and 12-min recovery including CWI (10 °C water), bilateral PMT on the anterior and posterior thigh, or passive resting. Outcomes will be assessed immediately after the exercise protocol, after the recovery intervention, and at 24 h. Isometric knee extension (IKE) and flexion (IKF), and tensiomyography (TMG) will be assessed.Muscle soreness and fatigue will be scored from 0 to 10.
Detailed description
Participants will be invited to participate to a cross-over randomized trial, consisting in 3 experimental sessions at 7 days of distance one from another. During each experimental session, participants will be asked to train for about 45 min at a high-intensity protocol (High-Intensity Intermittent Running, plyometric jumps and isometric chair position). After the exercise, participants will be assessed for neuromuscular function (isometric strength and tensiomyography) as well as perceived soreness and fatigue. Then, in a randomized order, participants will receive three different recovery interventions: cold water immersion, percussive massage, or a passive control condition. After the recovery intervention, outcomes are assessed again, as well as at 24 h. Isometric strength is assessed with a dynamometer during knee extension and knee flexion. Tensiomyography is performed on the thigh muscles, and time to contraction and radial displacement are considered as outcomes. Soreness and fatigue are rated by the participant from 0 to 10.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CWI | Experimental | Other: Cold Water ImmersionThe CWI protocol consists of participants standing, with only their underwear and a t-shirt, in a portable tub for cold water therapy (Qryo, Italy), with the water to their hips being constantly maintained at 10±0.5 °C by a cooling system that pumped and stirred the water inside the tub and around the participant's lower limbs. Water temperature and the duration of the immersion, which is 12 minutes for all the participants considering they were characterized by similar anthropometrics and body composition, were based on previous literature |
| PMT | Experimental | Device: Percussive Massage TherapyThe PMT protocol is performed with the application of a percussive therapy gun (Theragun Elite, Therabody, USA). The participants rests with their underwear and a t-shirt on a treatment bed, and the percussive therapy gun with a "standard ball", 16 mm amplitude of percussions, and a frequency of 30 Hz, is applied to the thigh muscles of both lower limbs, 3 min on the anterior and 3 min on the posterior area of each thigh. The protocol is based on previous literature and adapted to the specific aims of this study. |
| PAS | No intervention | –The control condition (PAS) consists of participants resting on a chair for 12 minutes in a quiet room at 25 °C. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- being healthy
- training in soccer for more than 3 years and with a training frequency > 2 times/week
Key exclusion criteria (2 listed)
- reported time-loss injuries
- using analgesics or other therapies affecting muscle function or pain
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 |
|---|---|---|
| Cold Water ImmersionCold water immersion consists in 12 min standing in 10 °C water | Other | CWI |
| Percussive Massage TherapyPercussive massage therapy is performed with a massage gun on the thigh muscles for 12 min | Device | PMT |
Primary outcome
Muscle soreness
Time frame: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Subjective evalutation of muscle soreness from 0 to 10 with a numeric rating scale (NRS), where 0 is no soreness at all, and 10 is unbearable soreness
Muscle fatigue
Time frame: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Subjective evaluation of muscle fatigue from 0 to 10 with a numeric rating scale (NRS), where 0 is no fatigue at all, and 10 is unbearable fatigue
2 secondary outcomes
Isometric muscle strength
Time frame: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Tensiomyography
Time frame: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
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 18 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Water Immersion and Percussive Massage Therapy in people with Muscle Soreness, run by University of Trieste at 1 site in Italy.
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 2 inclusion and 2 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 18 Jun 2024. 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 Italy. 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. 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?
Muscle soreness (time frame: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)). The study lists 2 primary outcomes in all. 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 18 Jun 2024.