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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06018779
Other study ID # MFR0032023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date April 15, 2023

Study information

Verified date August 2023
Source University of Palermo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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?


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date April 15, 2023
Est. primary completion date March 13, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 21 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cryoultrasound therapy plus high-intensity laser therapy
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 therapy
Group B received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and diathermy.

Locations

Country Name City State
Italy Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone Palermo

Sponsors (1)

Lead Sponsor Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary entity of the pain numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain. 2 weeks
Secondary size of the muscle tear measurement in centimeters by ultrasound. 2 weeks
Secondary frequency of relapses number of relapses 3 months after the injury
Secondary return to play number of days 3 months after the injury
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