Effectiveness of Physical Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study

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?

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 Overview

• Status: Completed
• Conditions: Athletic Injuries; Physical Therapies
• Intervention / Treatment: Other: Cryoultrasound therapy plus high-intensity laser therapy; Other: diathermy plus high-intensity laser therapy

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90127
    • Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Group A will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and high-intensity laser therapy	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.
Placebo Comparator: Group B; Group B will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and diathermy	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
entity of the pain	numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
size of the muscle tear	measurement in centimeters by ultrasound.	2 weeks
frequency of relapses	number of relapses	3 months after the injury
return to play	number of days	3 months after the injury

Collaborators and Investigators

• Sponsor: University of Palermo

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): March 13, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Estimated): August 31, 2023

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Athletic Injuries
• Other Study ID Numbers: MFR0032023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No