Back to resultsEffectiveness of Physical Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study
Primary Purpose
Athletic Injuries, Physical Therapies
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cryoultrasound therapy plus high-intensity laser therapy
diathermy plus high-intensity laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Athletic Injuries
Eligibility Criteria
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.
Sites / Locations
- Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A
Group B
Arm Description
Group A will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and high-intensity laser therapy
Group B will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and diathermy
Outcomes
Primary Outcome Measures
entity of the pain
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
measurement in centimeters by ultrasound.
frequency of relapses
number of relapses
return to play
number of days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06018779
Brief Title
Effectiveness of Physical Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo
4. Oversight
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
5. 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletic Injuries, Physical Therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and high-intensity laser therapy
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Group B will include patients who will receive a rehabilitation treatment consisting of: cryo-ultrasound therapy and diathermy
Intervention Type
Other
Intervention Name(s)
Cryoultrasound therapy plus high-intensity laser therapy
Intervention Description
Group A received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and cryo-sound therapy.
Intervention Type
Other
Intervention Name(s)
diathermy plus high-intensity laser therapy
Intervention Description
Group B received a daily rehabilitation treatment lasting 10 sessions for 10 consecutive sessions, consisting of high-intensity laser therapy and diathermy.
Primary Outcome Measure Information:
Title
entity of the pain
Description
numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
size of the muscle tear
Description
measurement in centimeters by ultrasound.
Time Frame
2 weeks
Title
frequency of relapses
Description
number of relapses
Time Frame
3 months after the injury
Title
return to play
Description
number of days
Time Frame
3 months after the injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
12. IPD Sharing Statement
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Effectiveness of Physical Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study
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