EFFECT of CRYOTHERAPY on KINEMATIC GAIT PARAMETERS in PATIENTS with CHRONIC PATELLOFEMORAL PAIN SYNDROME

this study show the EFFECT OF CRYOTHERAPY ON KINEMATIC GAIT PARAMETERS IN PATIENTS WITH CHRONIC PATELLOFEMORAL PAIN SYNDROME and review its reliability.

Participants were randomly allocated into two equal groups (A and B ) were done by a blinded independent researcher who opened enclosed envelopes containing computer generated randomization serially number index cards using statistical package for social science (SPSS),program (version 20 for windows ,spss, Chicago Illinois,USA) There were no dropouts among the participants throught the study after randomization.

Study Overview

• Status: Completed
• Conditions: CHRONIC PATELLOFEMORAL PAIN SYNDROME
• Intervention / Treatment: Other: Conservative treatment; Device: Cryotherapy Compression Machine

Detailed Description

Sixty patients from both genders were participated in this study. they were selected from the outpatient clinic of Faculty of Physical Therapy ,Cairo University with a PFPS.

The Patients of both genders with their ages were ranging from 18 to 40 years old and their BMI was from 20 to 25 kg/m2.

Thirty patients with PFPS, Their ages ranging from 18 to 40 years old ,Their BMI was from 20 to 25 kg/m2 received treatment in form of Traditional treatment (Strengthening exercise, Stretching, ultrasound and electrotherapy). The treatment performed three time a week for 4 weeks.

Thirty patients with PFPS, Their ages ranging from 18 to 40 years old ,Their BMI was from 20 to 25 kg/m2 received treatment in form of Traditional treatment (Strengthening exercise, Stretching, ultrasound and electrotherapy) with cryotherapy, The treatment performed three time a week for 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Physical Therapy College of Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patients were diagnosed as patellofemoral pain by an orthopedist.
• The participants were eligible to be included if they had bilateral PFPS or unilateral PFPS.
• Duration of knee pain is 4-5 weeks during 6 months prior to study. (Collins et al., 2010).
• Their ages were ranging from 18 to 40 years (Clin Rheumatol et al., 2012).
• Their BMI was ranging from(20 to 25 kg/m2) (Fischer et al., 2009)

Exclusion Criteria:

• • Rheumatoid Arthritis or other systemic rheumatic diseases.

  • Dementia, psychosis.
  • Active substance abuse disorder; acute or chronic disease, injury, deformity.
  • Operation of the lower limb and knee.
  • Severe hearing or visual impairment.
  • Hospitalization for a cardiovascular condition, cerebral infarction or arrhythmia in the previous 3 months.
  • Recent history of 3 or more falls.
  • Current participation in another OA intervention study.
  • Uncontrolled diabetes mellitus.
  • Intra-articular knee injections in the previous 6 months.
  • Contraindications to cryotherapy application those that feel a high level of discomfort or pain during the application.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (control group); Thirty patients with PFPS, Their ages ranging from 18 to 40 years old ,Their BMI was from 20 to 25 kg/m2 received treatment in form of Traditional treatment (Strengthening exercise, Stretching, ultrasound and electrotherapy). The treatment performed three time a week for 4 weeks	Other: Conservative treatment; Strength and stretch exercises for hip and knee large groups of muscles.
Experimental: Group B (Study group); Thirty patients with PFPS, Their ages ranging from 18 to 40 years old ,Their BMI was from 20 to 25 kg/m2 received treatment in form of Traditional treatment (Strengthening exercise, Stretching, ultrasound and electrotherapy) with cryotherapy, The treatment performed three time a week for 4 weeks.	Device: Cryotherapy Compression Machine; The Cryo Pro is a simple to use cold compression therapy product that requires only ice, water and power. It's unique design is convenient to use, provides pain relief and reduces swelling and inflammation, making recovery faster.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biodex Gait Trainer	treadmill with real-time step length visualization (where the foot was placed) was used to assess the selected spatiotemporal gait parameters. During the test, the patient was visually informed about the suggested foot placement/planned length of the step. This three-minute extended test was conducted before and after the rehabilitation program.	4 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2023
• Primary Completion (Actual): October 8, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 25, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cryotherapy; compression cryotherapy; Biodex Gait Trainer
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mental Disorders; Pathologic Processes; Joint Diseases; Disease; Somatoform Disorders; Syndrome; Patellofemoral Pain Syndrome
• Other Study ID Numbers: P.T.REC/012/004880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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