CHRONIC PATELLOFEMORAL PAIN SYNDROMENCT06795269
EFFECT OF CRYOTHERAPY ON KINEMATIC GAIT PARAMETERS IN PATIENTS WITH CHRONIC PATELLOFEMORAL PAIN SYNDROME
A study testing Cryotherapy Compression Machine and Conservative treatment in people with CHRONIC PATELLOFEMORAL PAIN SYNDROME, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- CHRONIC PATELLOFEMORAL PAIN SYNDROME
- What is being tested?
- Cryotherapy Compression Machine and Conservative treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Oct 2023to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- • 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Physical Therapy College of Cairo University
Giza, Giza Governorate, 12613
About this study
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.
Read the 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.
- Conditions
- CHRONIC PATELLOFEMORAL PAIN SYNDROME
- Being tested
- Cryotherapy Compression Machine, Conservative treatment
- Keywords
- Cryotherapy, compression cryotherapy, Biodex Gait Trainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy Compression MachineDevice
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.
Conservative treatmentOther
Strength and stretch exercises for hip and knee large groups of muscles.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Cryotherapy Compression Machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start8 Oct 2023
- Primary completion8 Oct 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHRONIC PATELLOFEMORAL PAIN SYNDROMEStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makarious Adel Anwar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795269
- Sponsor's protocol ID
- P.T.REC/012/004880
- Status last verified
- Oct 2023
- First submitted
- 16 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF CRYOTHERAPY ON KINEMATIC GAIT PARAMETERS IN PATIENTS WITH CHRONIC PATELLOFEMORAL PAIN SYNDROME
- ClinicalTrials.gov ID
- NCT06795269
- Acronym / sponsor ID
- P.T.REC/012/004880
- Conditions
- CHRONIC PATELLOFEMORAL PAIN SYNDROME
- Keywords
- Cryotherapy, compression cryotherapy, Biodex Gait Trainer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (control group) | Active comparator | Other: Conservative treatmentThirty 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 |
| Group B (Study group) | Experimental | Device: Cryotherapy Compression MachineThirty 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- • Rheumatoid Arthritis or other systemic rheumatic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotherapy Compression MachineThe 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. | Device | Group B (Study group) |
| Conservative treatmentStrength and stretch exercises for hip and knee large groups of muscles. | Other | Group A (control group) |
Primary outcome
Biodex Gait Trainer
Time frame: 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy Compression Machine and Conservative treatment in people with CHRONIC PATELLOFEMORAL PAIN SYNDROME, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex Gait Trainer (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.