- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06766318
Cryo-ultrasound Versus LASER Therapy on Ankle Sprain in Tennis Players
January 11, 2025 updated by: Kerolous Ishak Shehata, October 6 University
the effect cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Cairo University
-
Cairo, Egypt
- Kerolous Ishak Shehata Kelini
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: cryo-ultrasound group (n = 20): received cryo-ultrasound therapy
received cryo-ultrasound therapy combined with conventional physical therapy
|
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
|
|
Experimental: Laser group
receive LASER therapy combined with conventional physical therapy
|
group B will receive LASER therapy combined with conventional physical therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
2 months
|
|
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
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kerolous Ishak Kelini, PHD, Al-Zaytoonah University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2024
Primary Completion (Actual)
July 16, 2024
Study Completion (Actual)
October 25, 2024
Study Registration Dates
First Submitted
January 4, 2025
First Submitted That Met QC Criteria
January 4, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 11, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/012/005532
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.