NCT06795269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
Last Updated

January 28, 2025

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

January 16, 2025

Last Update Submit

January 25, 2025

Conditions

Keywords

Cryotherapycompression cryotherapyBiodex Gait Trainer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group A (control group)

ACTIVE COMPARATOR

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

Group B (Study group)

EXPERIMENTAL

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

Interventions

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.

Group B (Study group)

Strength and stretch exercises for hip and knee large groups of muscles.

Group A (control group)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy College of Cairo University

Giza, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist specialist

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 28, 2025

Study Start

October 8, 2023

Primary Completion

October 8, 2024

Study Completion

December 20, 2024

Last Updated

January 28, 2025

Record last verified: 2023-10

Locations