Athletic InjuriesNCT06018779
Effectiveness of Physical Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study
A study testing Cryoultrasound therapy plus high-intensity laser therapy and diathermy plus high-intensity laser therapy in people with Athletic Injuries and Physical Therapies, run by University of Palermo at 1 site in Italy.
Trial summary
The objective of this study was to evaluate the efficacy of cryoultrasound therapy versus diathermy in combination with high-intensity laser therapy for pain relief in male professional soccer players with muscle injuries. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Injuries, Physical Therapies
- What is being tested?
- Cryoultrasound therapy plus high-intensity laser therapy and diathermy plus high-intensity laser therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 15 Apr 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 18 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-21 years;
- professional footballer in a competitive club;
- presence of a grade III A muscle lesion, according to the Mueller-Wohlfart classification, confirmed by ultrasound examination and occurring during sports activity at least 5 days before inclusion in the present study;
- no previous muscle injuries in the last 6 months;
- signature of the written informed consent for participating in the study.
Who cannot join
- previous muscle injuries or bone fractures of the lower limbs in the last 6 months;
- knee instability due to previous rupture of knee ligaments;
- active neoplastic or infectious diseases;
- congenital anomalies of the lower limbs.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Palermo, 90127
About this study
Official title: Effectiveness of Cryo Plus Ultrasound Therapy Versus Diathermy in Combination With High-intensity Laser Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study
The objective of this study was to evaluate the efficacy of cryoultrasound therapy versus diathermy in combination with high-intensity laser therapy for pain relief in male professional soccer players with muscle injuries. The main questions it intends to answer are:
- Is this combination of treatments effective in these patients in terms of pain relief?
Read more
Participants will receive a rehabilitation treatment consisting of cryo-ultrasound therapy and high intensity laser. Researchers will compare the group of participants, called the treatment group, with a control group to see if:
- Is the combined treatment of cryoultrasound therapy and high intensity laser more effective in these patients than the combination of diathermy and high intensity laser?
- Conditions
- Athletic Injuries, Physical Therapies
- Being tested
- Cryoultrasound therapy plus high-intensity laser therapy, diathermy plus high-intensity laser therapy
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoultrasound therapy plus high-intensity laser therapyOther
Group A received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and cryo-sound therapy.
diathermy plus high-intensity laser therapyOther
Group B received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and diathermy.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and high-intensity laser therapy Receives: Other: Cryoultrasound therapy plus high-intensity laser therapy |
| Group B | Placebo comparator | Group B will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and diathermy Receives: Other: diathermy plus high-intensity laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
entity of the pain
numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.
Measured: 2 weeks
Secondary outcomes (3)
size of the muscle tear
measurement in centimeters by ultrasound.
Measured: 2 weeks
frequency of relapses
number of relapses
Measured: 3 months after the injury
return to play
number of days
Measured: 3 months after the injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Sep 2022
- Primary completion13 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic InjuriesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018779
- Sponsor's protocol ID
- MFR0032023
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cryo Plus Ultrasound Therapy Versus Diathermy in Combination With High-intensity Laser Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study
- ClinicalTrials.gov ID
- NCT06018779
- Acronym / sponsor ID
- MFR0032023
- Conditions
- Athletic Injuries, Physical Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 31 Aug 2023 (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.
The objective of this study was to evaluate the efficacy of cryoultrasound therapy versus diathermy in combination with high-intensity laser therapy for pain relief in male professional soccer players with muscle injuries. The main questions it intends to answer are:
- Is this combination of treatments effective in these patients in terms of pain relief?
Participants will receive a rehabilitation treatment consisting of cryo-ultrasound therapy and high intensity laser. Researchers will compare the group of participants, called the treatment group, with a control group to see if:
- Is the combined treatment of cryoultrasound therapy and high intensity laser more effective in these patients than the combination of diathermy and high intensity laser?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Cryoultrasound therapy plus high-intensity laser therapyGroup A will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and high-intensity laser therapy |
| Group B | Placebo comparator | Other: diathermy plus high-intensity laser therapyGroup B will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and diathermy |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 18-21 years;
- professional footballer in a competitive club;
- presence of a grade III A muscle lesion, according to the Mueller-Wohlfart classification, confirmed by ultrasound examination and occurring during sports activity at least 5 days before inclusion in the present study;
- no previous muscle injuries in the last 6 months;
- signature of the written informed consent for participating in the study.
Key exclusion criteria (4 listed)
- previous muscle injuries or bone fractures of the lower limbs in the last 6 months;
- knee instability due to previous rupture of knee ligaments;
- active neoplastic or infectious diseases;
- congenital anomalies of the lower limbs.
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 |
|---|---|---|
| Cryoultrasound therapy plus high-intensity laser therapyGroup A received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and cryo-sound therapy. | Other | Group A |
| diathermy plus high-intensity laser therapyGroup B received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and diathermy. | Other | Group B |
Primary outcome
entity of the pain
Time frame: 2 weeks
numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.
3 secondary outcomes
size of the muscle tear
Time frame: 2 weeks
frequency of relapses
Time frame: 3 months after the injury
return to play
Time frame: 3 months after the injury
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 31 Aug 2023.
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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 Cryoultrasound therapy plus high-intensity laser therapy and diathermy plus high-intensity laser therapy in people with Athletic Injuries and Physical Therapies, run by University of Palermo 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 5 inclusion and 4 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 31 Aug 2023. 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. 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?
entity of the pain (time frame: 2 weeks). 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 31 Aug 2023.