Patellofemoral Pain SyndromeNCT06017778
Impact Of Whole Body Vibration on Planter /Dorsi Flexor Ratio, Pain and Functional Activities in Patellofemoral Pain Syndrome
A study testing whole body vibration and traditional exercise group in people with Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Patellofemoral pain syndrome (PFPS) can significantly affect an individual's ability perform to functional activities, such as walking, running, climbing stairs, and sitting for prolonged periods. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- whole body vibration and traditional exercise group
- 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
- 30 Aug 2023to 30 Nov 2023
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: Adults aged 18 -35 years
- Symptoms: Pain in the anterior or retro patellar knee region during activities such as running, jumping, squatting, or prolonged sitting
- Duration: Pain lasting at least 6 weeks
Who cannot join
- Presence of other knee conditions: Individuals with PFPS who also have other knee conditions such as ligament or meniscal injuries, osteoarthritis, or patellar tendinopathy may be excluded.
- History of knee surgery: Patients who have undergone any knee surgery may be excluded as this may affect the outcomes of the study.
- Systemic conditions: Patients with systemic conditions that may affect the musculoskeletal system such as rheumatoid arthritis or lupus may be excluded.
- Pregnancy: Pregnant women with PFPS may be excluded as pregnancy may affect the outcomes of the study.
- Inability to comply with study requirements: Patients who are unable to comply with the study requirements such as attending follow-up appointments or completing questionnaires may be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy , cairo university
Giza
Radwa
About this study
Official title: Impact Of Whole Body Vibration on Planter /Dorsi Flexor Ratio, Pain and Functional Activities in Patellofemoral Pain Syndrome: Randomized Controlled Trial
Patellofemoral pain syndrome (PFPS) can significantly affect an individual's ability perform to functional activities, such as walking, running, climbing stairs, and sitting for prolonged periods.
PFPS is often associated with pain and discomfort in the front of the knee, which can limit an individual's range of motion and cause difficulty with weight-bearing activities. The pain may also be exacerbated by activities that involve bending the knee, such as squatting or kneeling.
Whole body vibration (WBV) has been suggested as a potential intervention for patellofemoral pain syndrome (PFPS). Some studies have shown that WBV can improve muscle strength, balance, and proprioception, which are all factors that may contribute to PFPS. Additionally, WBV may help reduce pain and improve functional abilities in individuals with PFPS However, the evidence for the effectiveness of WBV as an intervention for PFPS is still limited, and more research is needed to fully understand its potential benefits and limitations. It is important to note that WBV may not be suitable for all individuals with PFPS.
Read the detailed description
Patellofemoral pain syndrome (PFPS) can significantly affect an individual's ability perform to functional activities, such as walking, running, climbing stairs, and sitting for prolonged periods.
PFPS is often associated with pain and discomfort in the front of the knee, which can limit an individual's range of motion and cause difficulty with weight-bearing activities. The pain may also be exacerbated by activities that involve bending the knee, such as squatting or kneeling.
Whole body vibration (WBV) has been suggested as a potential intervention for patellofemoral pain syndrome (PFPS). Some studies have shown that WBV can improve muscle strength, balance, and proprioception, which are all factors that may contribute to PFPS. Additionally, WBV may help reduce pain and improve functional abilities in individuals with PFPS.
However, the evidence for the effectiveness of WBV as an intervention for PFPS is still limited, and more research is needed to fully understand its potential benefits and limitations. It is important to note that WBV may not be suitable for all individuals with PFPS.
HYPOTHESES:
There will be no significant difference on dorsi/planter flexor ratio , functional activities and pain level after adding the whole body vibration to traditional treatment of PFPS
RESEARCH QUESTION:
What is the impact of whole-body vibration on dorsi/planter flexor ratio, functional activities and pain levels in individuals with PFPS?
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- whole body vibration, traditional exercise group
- Keywords
- Patellofemoral pain syndrome, vibration, Planter/Dorsi ratio, pain
- Medical subject headings
- Patellofemoral Pain Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibrationDevice
patients will receive WBV training in addition to traditional training will be performed on a tri-planar (mostly vertical, Z axis) oscillating vibration platform (Power PlateR pro5™; Power Plate North America, Inc., Northbrook, IL,USA) for 20-30 minutes per session. WBV training will be supervised and performed in a clinic three days a week with at least one day between each session for four weeks (total of 12 sessions).
traditional exercise groupOther
10 minutes warm-up (lower extremity stretching exercises), 20-30 minutes period of strength exercises with three sets of 10-15 repetitions (isometric quadriceps setting, knee extensions, double-legged wall squat), and 5 minutes cool-down (lower extremity stretching exercises). Lower extremity stretching exercises consisted of quadriceps, hamstring, gastrocnemius and iliotibial band stretching with 3 repetitions for 30 s each muscle.
| Study group | Role | What they receive |
|---|---|---|
| whole body viberation group | Experimental | Not described Receives: Device: whole body vibration; Other: traditional exercise group |
| control group | Active comparator | Not described Receives: Other: traditional exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dorsi/planter torque ratio
dorsi/planter torque ratio will be measured through the Biodex System 4-Pro Isokinetic Strength Dynamometer for assessment of muscle torque
Measured: one month
functional activities
Kujala Anterior Knee Pain Scale, which includes questions related to functional activities.
Measured: one month
Pain intensity
10 cm Visual Analogue Scale (VAS) was used to assess pain intensity during activity in patients with patellofemoral pain (PFP). The scale ranged from 0, indicating "no pain," to 100, representing the "worst pain imaginable.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa T. Elshorbagy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017778
- Sponsor's protocol ID
- 012/004572
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Whole Body Vibration on Planter /Dorsi Flexor Ratio, Pain and Functional Activities in Patellofemoral Pain Syndrome: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06017778
- Acronym / sponsor ID
- 012/004572
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral pain syndrome, vibration, Planter/Dorsi ratio, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 30 Aug 2023 (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.
Patellofemoral pain syndrome (PFPS) can significantly affect an individual's ability perform to functional activities, such as walking, running, climbing stairs, and sitting for prolonged periods.
PFPS is often associated with pain and discomfort in the front of the knee, which can limit an individual's range of motion and cause difficulty with weight-bearing activities. The pain may also be exacerbated by activities that involve bending the knee, such as squatting or kneeling.
Whole body vibration (WBV) has been suggested as a potential intervention for patellofemoral pain syndrome (PFPS). Some studies have shown that WBV can improve muscle strength, balance, and proprioception, which are all factors that may contribute to PFPS. Additionally, WBV may help reduce pain and improve functional abilities in individuals with PFPS However, the evidence for the effectiveness of WBV as an intervention for PFPS is still limited, and more research is needed to fully understand its potential benefits and limitations. It is important to note that WBV may not be suitable for all individuals with PFPS.
Detailed description
Patellofemoral pain syndrome (PFPS) can significantly affect an individual's ability perform to functional activities, such as walking, running, climbing stairs, and sitting for prolonged periods.
PFPS is often associated with pain and discomfort in the front of the knee, which can limit an individual's range of motion and cause difficulty with weight-bearing activities. The pain may also be exacerbated by activities that involve bending the knee, such as squatting or kneeling.
Whole body vibration (WBV) has been suggested as a potential intervention for patellofemoral pain syndrome (PFPS). Some studies have shown that WBV can improve muscle strength, balance, and proprioception, which are all factors that may contribute to PFPS. Additionally, WBV may help reduce pain and improve functional abilities in individuals with PFPS.
However, the evidence for the effectiveness of WBV as an intervention for PFPS is still limited, and more research is needed to fully understand its potential benefits and limitations. It is important to note that WBV may not be suitable for all individuals with PFPS.
HYPOTHESES:
There will be no significant difference on dorsi/planter flexor ratio , functional activities and pain level after adding the whole body vibration to traditional treatment of PFPS
RESEARCH QUESTION:
What is the impact of whole-body vibration on dorsi/planter flexor ratio, functional activities and pain levels in individuals with PFPS?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole body viberation group | Experimental | Device: whole body vibration, Other: traditional exercise group |
| control group | Active comparator | Other: traditional exercise group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: Adults aged 18 -35 years
- Symptoms: Pain in the anterior or retro patellar knee region during activities such as running, jumping, squatting, or prolonged sitting
- Duration: Pain lasting at least 6 weeks
Key exclusion criteria (5 listed)
- Presence of other knee conditions: Individuals with PFPS who also have other knee conditions such as ligament or meniscal injuries, osteoarthritis, or patellar tendinopathy may be excluded.
- History of knee surgery: Patients who have undergone any knee surgery may be excluded as this may affect the outcomes of the study.
- Systemic conditions: Patients with systemic conditions that may affect the musculoskeletal system such as rheumatoid arthritis or lupus may be excluded.
- Pregnancy: Pregnant women with PFPS may be excluded as pregnancy may affect the outcomes of the study.
- Inability to comply with study requirements: Patients who are unable to comply with the study requirements such as attending follow-up appointments or completing questionnaires may be excluded.
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 |
|---|---|---|
| whole body vibrationpatients will receive WBV training in addition to traditional training will be performed on a tri-planar (mostly vertical, Z axis) oscillating vibration platform (Power PlateR pro5™; Power Plate North America, Inc., Northbrook, IL,USA) for 20-30 minutes per session. WBV training will be supervised and performed in a clinic three days a week with at least one day between each session for four weeks (total of 12 sessions). | Device | whole body viberation group |
| traditional exercise group10 minutes warm-up (lower extremity stretching exercises), 20-30 minutes period of strength exercises with three sets of 10-15 repetitions (isometric quadriceps setting, knee extensions, double-legged wall squat), and 5 minutes cool-down (lower extremity stretching exercises). Lower extremity stretching exercises consisted of quadriceps, hamstring, gastrocnemius and iliotibial band stretching with 3 repetitions for 30 s each muscle. | Other | control group, whole body viberation group |
Primary outcome
Dorsi/planter torque ratio
Time frame: one month
dorsi/planter torque ratio will be measured through the Biodex System 4-Pro Isokinetic Strength Dynamometer for assessment of muscle torque
functional activities
Time frame: one month
Kujala Anterior Knee Pain Scale, which includes questions related to functional activities.
Pain intensity
Time frame: one month
10 cm Visual Analogue Scale (VAS) was used to assess pain intensity during activity in patients with patellofemoral pain (PFP). The scale ranged from 0, indicating "no pain," to 100, representing the "worst pain imaginable.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Yes
Related trials for Patellofemoral Pain Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration and traditional exercise group in people with 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radwa Elshorbagy (00966500920691, Rtelshorbagy@ju.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dorsi/planter torque ratio (time frame: one month). The study lists 3 primary outcomes in all. 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 30 Aug 2023.