Ankle (Ligaments); Instability (Old Injury)NCT06766318
Cryo-ultrasound Versus LASER Therapy on Ankle Sprain in Tennis Players
A study testing group A will receive cryo-ultrasound therapy combined with conventional physical therapy for two months and LASER therapy in people with Ankle (Ligaments); Instability (Old Injury), run by October 6 University at 2 sites in Egypt.
Trial summary
the effect cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains. Read more about this study
- Who is it for?
- Ages 12 to 16 years, women only
- Conditions the study is for
- Ankle (Ligaments); Instability (Old Injury)
- What is being tested?
- group A will receive cryo-ultrasound therapy combined with conventional physical therapy for two months and LASER therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 9 Feb 2024to 25 Oct 2024
- 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 12 to 16 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Age ranged from 12-16 years.
- elite girls;
- semi-professional tennis players;
- I-II grade lateral ankle sprain injury;
- no persistent instability phenomena or chronic sprains;
- acute injury (within 2 weeks from trauma);
- no evidence of bone edema or skin disorder, once the area of intense pain in motion was delimited, the lack of neurological disturbances was investigated and assessed.
Who cannot join
- history of recurrent dislocation of the ankle or hyperlaxity of any joint;
- severe rheumatic diseases and/or collagen diseases;
- athletes who have received any form of local physical therapy and NSAIDs within the last 2 months prior to injury;
- athletes who admit to using steroids;
- any contraindication and/or limitation to the use of a physical agent modality (implantable electrophysiological devices, active neoplasms). Taking medications.
- Athletic adult.
Trial locations and contacts
2 sites in 1 country.
About this study
the effect cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains.
Read the detailed description
Acute lateral ankle sprains are common injuries among athletes, but the optimal treatment strategies in elite athletes are still debated. This proof-of-concept study aimed to assess the impact of cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains.
- Being tested
- group A will receive cryo-ultrasound therapy combined with conventional physical therapy for two months, LASER therapy
- Keywords
- cryoultrasound, laser, Ankle sprain, Tennis players, Elite girl
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group A will receive cryo-ultrasound therapy combined with conventional physical therapy for two monthsDevice
Cryo-ultrasound therapy combines two therapeutic methods: cryotherapy (using cold) and ultrasound (using sound waves). The ultrasound component provides a therapeutic heating effect, improving blood circulation and tissue flexibility, while the cold component reduces pain and inflammation
LASER therapyDevice
group B will receive LASER therapy combined with conventional physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| cryo-ultrasound group (n = 20): received cryo-ultrasound therapy | Experimental | received cryo-ultrasound therapy combined with conventional physical therapy Receives: Device: group A will receive cryo-ultrasound therapy combined with conventional physical therapy for two months |
| Laser group | Experimental | receive LASER therapy combined with conventional physical therapy Receives: Device: LASER therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity a
We will assess pain intensity before and after intervension by numeric pain rating scale, which is numerical from 0 indicate no pain and 10 indicate the worest pain
Measured: 2 months
Foot and Ankle Disability Index
Foot and Ankle Disability Index (FADI) at baseline (T0) at the end of treatment (T1), after one month (T2), and two months after treatment (T3).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start9 Feb 2024
- Primary completion16 Jul 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle (Ligaments); Instability (Old Injury)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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolous Ishak Shehata, October 6 University
- Investigators
- Kerolous Ishak Kelini, PHD, Principal investigator, AL-Zaytoonah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766318
- Sponsor's protocol ID
- REC/012/005532
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 14 Jan 2025
- 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryo-ultrasound Versus LASER Therapy on Ankle Sprain in Tennis Players
- ClinicalTrials.gov ID
- NCT06766318
- Acronym / sponsor ID
- REC/012/005532
- Keywords
- cryoultrasound, laser, Ankle sprain, Tennis players, Elite girl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 9 Jan 2025 (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 effect cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains.
Detailed description
Acute lateral ankle sprains are common injuries among athletes, but the optimal treatment strategies in elite athletes are still debated. This proof-of-concept study aimed to assess the impact of cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cryo-ultrasound group (n = 20): received cryo-ultrasound therapy | Experimental | Device: group A will receive cryo-ultrasound therapy combined with conventional physical therapy for two monthsreceived cryo-ultrasound therapy combined with conventional physical therapy |
| Laser group | Experimental | Device: LASER therapyreceive LASER therapy combined with conventional physical therapy |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age ranged from 12-16 years.
- elite girls;
- semi-professional tennis players;
- I-II grade lateral ankle sprain injury;
- no persistent instability phenomena or chronic sprains;
Key exclusion criteria (6 listed)
- history of recurrent dislocation of the ankle or hyperlaxity of any joint;
- severe rheumatic diseases and/or collagen diseases;
- athletes who have received any form of local physical therapy and NSAIDs within the last 2 months prior to injury;
- athletes who admit to using steroids;
- any contraindication and/or limitation to the use of a physical agent modality (implantable electrophysiological devices, active neoplasms). Taking medications.
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 |
|---|---|---|
| group A will receive cryo-ultrasound therapy combined with conventional physical therapy for two monthsCryo-ultrasound therapy combines two therapeutic methods: cryotherapy (using cold) and ultrasound (using sound waves). The ultrasound component provides a therapeutic heating effect, improving blood circulation and tissue flexibility, while the cold component reduces pain and inflammation | Device | cryo-ultrasound group (n = 20): received cryo-ultrasound therapy |
| LASER therapygroup B will receive LASER therapy combined with conventional physical therapy. | Device | Laser group |
Primary outcome
Pain intensity a
Time frame: 2 months
We will assess pain intensity before and after intervension by numeric pain rating scale, which is numerical from 0 indicate no pain and 10 indicate the worest pain
Foot and Ankle Disability Index
Time frame: 2 months
Foot and Ankle Disability Index (FADI) at baseline (T0) at the end of treatment (T1), after one month (T2), and two months after treatment (T3).
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 14 Jan 2025.
- 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.
Kerolous Ishak Kelini, PHD principal investigator
AL-Zaytoonah University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group A will receive cryo-ultrasound therapy combined with conventional physical therapy for two months and LASER therapy in people with Ankle (Ligaments); Instability (Old Injury), run by October 6 University at 2 sites in Egypt.
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 7 inclusion and 6 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 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Pain intensity a (time frame: 2 months). 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 14 Jan 2025.