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

Sponsor

University of Palermo (Other)

Overall Status

Completed

CT.gov ID

NCT06018779

Collaborator

(none)

Enrollment

Location

Arms

7.4

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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?

Condition or Disease	Intervention/Treatment	Phase
Athletic Injuries Physical Therapies	Other: Cryoultrasound therapy plus high-intensity laser therapy Other: diathermy plus high-intensity laser therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2022

Actual Primary Completion Date :

Mar 13, 2023

Actual Study Completion Date :

Apr 15, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

entity of the pain [2 weeks]
numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.

Secondary Outcome Measures

size of the muscle tear [2 weeks]
measurement in centimeters by ultrasound.
frequency of relapses [3 months after the injury]
number of relapses
return to play [3 months after the injury]
number of days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone	Palermo		Italy	90127

Sponsors and Collaborators

University of Palermo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof.ssa Giulia Letizia Mauro, Professor, University of Palermo

ClinicalTrials.gov Identifier:

NCT06018779

Other Study ID Numbers:

MFR0032023

First Posted:

Aug 31, 2023

Last Update Posted:

Aug 31, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Wounds and Injuries

Athletic Injuries

Study Results

No Results Posted as of Aug 31, 2023