NCT06766318

Brief Summary

the effect cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 4, 2025

Last Update Submit

January 11, 2025

Conditions

Keywords

cryoultrasoundlaserAnkle sprainTennis playersElite girl

Outcome Measures

Primary Outcomes (2)

  • 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

    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).

    2 months

Study Arms (2)

cryo-ultrasound group (n = 20): received cryo-ultrasound therapy

EXPERIMENTAL

received cryo-ultrasound therapy combined with conventional physical therapy

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

Device: LASER therapy

Interventions

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

cryo-ultrasound group (n = 20): received cryo-ultrasound therapy

group B will receive LASER therapy combined with conventional physical therapy.

Laser group

Eligibility Criteria

Age12 Years - 16 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University

Cairo, Egypt

Location

Kerolous Ishak Shehata Kelini

Cairo, Egypt

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Kerolous Ishak Kelini, PHD

    AL-Zaytoonah University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 4, 2025

First Posted

January 9, 2025

Study Start

February 9, 2024

Primary Completion

July 16, 2024

Study Completion

October 25, 2024

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations