Patellofemoral Pain SyndromeNCT06674707
Effects of Agility Training With and Without Foot Mobilization In Patellofemoral Pain Syndrome.
A study testing Agility Training with Foot mobilization. and Agility Training without Foot mobilization in people with Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Patellofemoral pain syndrome (PFPS) is referred to as peripatellar or retro-patellar pain, which is characterized by alterations in the physical and biomechanical features of the patellofemoral joint. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Agility Training with Foot mobilization. and Agility Training without Foot mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Jan 2024to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical signs of patellofemoral pain syndrome such as retro patellar pain, crepitation, and pain with patellar grinding more than 6 months.
- Both genders of 20-40 years of age.
- Presence of pain on step down from a 25 step or double leg squat and sitting with knee bent greater than 15 min.
- Pain more than 4 on NPRS scale.
- Individual with anterior left/right asymmetries greater than 4 cm on Y balance test
- Excessive calcaneal eversion measured at 6° in the relaxed posture(6).
Who cannot join
- History of ligament and meniscal injury.
- History of lower limb fractures.
- History of post-surgical condition of lower limb
- History of systemic, connective tissue or neurologic condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Al- Rehman Hospital
Lahore, Punjab Province, 54000
Agha Salman Khan, MS-OMPT, 03204646644, aghask5@gmail.com
Hira Nawaz, MS-OMPT
About this study
Official title: Effects of Agility Training With and Without Foot Mobilization On Pain, Balance and Functional Performance In Patellofemoral Pain Syndrome.
Patellofemoral pain syndrome (PFPS) is referred to as peripatellar or retro-patellar pain, which is characterized by alterations in the physical and biomechanical features of the patellofemoral joint. Risk factors for PFPS include: anatomic anomalies, mal-alignment and altered biomechanics of the lower extremity, muscle dysfunction, patellar hypermobility, poor quadriceps, or iliotibial band flexibility, surgery, tight lateral structures, training errors or overuse and trauma. The aim of this study is to compare the effects of foot mobilization with and without agility training on pain, balance and functional performance in patellofemoral pain syndrome.
Read the detailed description
A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore, Al Rehman Hospital, through convenient purposive sampling technique on 42 patients which will be allocated through using simple randomization into Group A and Group B. Group A will be treated with agility training and foot mobilization in patellofemoral pain syndrome and Group B will be treated with agility training without foot mobilization in patellofemoral pain syndrome thrice a week for 6 weeks. Outcome measures will be conducted through pain (NPRS), Kujala patellofemoral pain scale, Y balance test and Navicular droop test before and after 6 weeks. Data will be analyzed using SPSS software version 25.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Agility Training with Foot mobilization., Agility Training without Foot mobilization
- Keywords
- Balance, Functional Performance, Flat foot, Kujala function scale, Patellofemoral pain syndrome, Pain
- Medical subject headings
- Patellofemoral Pain Syndrome, Flatfoot, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agility Training with Foot mobilization.Other
Also called Simple conventional Treatment
Agility training with foot mobilization with the frequency of 3 sets of 10 repetitions thrice per week for a total six weeks. Pre and post intervention values will be taken on 1st day and after six weeks. Agility training includes side stepping, braiding activities, and front and back crossover steps during forward ambulation, shuttle walking, multiple changes in direction during walking on therapist command. TJM is a grade III Maitland technique and is applied with a high amplitude from the end range and 1s of vibration in the middle range of the joint through a linear motion to where tissue resistance is felt in the prone position, the patient is supported by a towel placed under the foot. Two sets of 5 min total were performed for 6weeks.
Agility Training without Foot mobilizationOther
Also called Simple Conventional Treatment
Agility training includes side stepping, braiding activities, and front and back crossover steps during forward ambulation, shuttle walking, multiple changes in direction during walking on therapist command. Comprising of Hot pack and TENS for 10 minutes and Ultrasound for 5 minutes . Comprising of conventional exercises were given for 3 sessions per week for 6 weeks. It includes semi squat, quadriceps isometric, terminal knee extension with elastic band, terminal knee extension in supine position, and adductor squeeze in crook lying (squeeze the ball).
| Study group | Role | What they receive |
|---|---|---|
| Agility Training with Foot Mobilization | Experimental | Agility Training with Foot Mobilization along with simple conventional treatment Receives: Other: Agility Training with Foot mobilization. |
| Agility Training without Foot Mobilization. | Active comparator | Agility training without foot mobilization along with simple conventional treatment. Receives: Other: Agility Training without Foot mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS):
The outcome was the 11-point NPRS to measure pain intensity. The NPRS defines pain intensity from 0 to 10 points, with 0 and 10 points indicating no pain and the most severe pain respectively. The reported test-retest reliability (intraclass correlation coefficient [ICC]) was 0.76, demonstrating it to be a good indicator of pain intensity.
Measured: 6 weeks
Kujala Patellofemoral Pain Scale
Anterior knee pain scale is frequently referred as Kujala scale. It's a 13 item questionnaire including different items on pain related to function and activities. The items assessed in the questionnaire are patellar subluxation, claudication, pain, walking, climbing stairs and prolonged sitting with the knees flexed. It has a score from 0 to 100 points, where 100 means without pain and functional limitations and 0 means constant pain and various functional limitations.
Measured: 6 weeks
Y Balance Test
The YBT assesses the balance by challenging his postural control system in 3 (anterior, posteromedial, and posterolateral) of the 8 SEBT (star excursion balance test) directions and has been advocated as a method for assessing dynamic balance (requires strength, flexibility and proprioception). The Y balance score was calculated by dividing the sum of the maximum reach distance in the anterior (A), posteromedial (PM), and posterolateral (PL) directions by 3 times the limb length (LL) of the individual, then multiplied by 100.
Measured: 6 weeks
Navicular Droop Test
Position the patient in standing so there is full weight-bearing through the lower extremity and ensure the foot is in the subtalar joint neutral position ("talar head congruent"). Mark the most prominent part of the navicular tuberosity and measure its distance from the supporting surface floor or step. Ask the patient to relax and then measure the amount of sagittal plane excursion of the navicular with a ruler. Alternatively, the test can also be performed in reverse, measuring from relaxed position up to talar neutral in standing postion. Many clinicians also choose to perform this test by marking the start and end position of the navicular on an index card placed along the inside of the foot and then measure the change with a ruler. The ICC2,1 values in the sitting and standing positions were 0.93 and 0.95, respectively, indicating significantly high inter-rater reliability.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start4 Jan 2024
- Primary completion7 Jan 2025 (estimated)
- Study completion7 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Raza, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674707
- Sponsor's protocol ID
- REC/RCR & AHS/24/0131
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luza LP, Luza M, Santos GM. Patellofemoral Pain Syndrome Modifies the Movement of the Rearfoot, but It Does Not Alter Plantar Pressure Distribution. Rev Bras Ortop (Sao Paulo). 2020 Aug;55(4):419-425. doi: 10.1055/s-0039-1698802. Epub 2019 Dec 13.
PubMed 32904777Gomez Carrion A, de Los Angeles Atin Arratibel M, Morales Lozano MR, Martinez Sebastian C, de la Cruz Torres B, Sanchez-Gomez R. Kinematic Effect on the Navicular Bone with the Use of Rearfoot Varus Wedge. Sensors (Basel). 2022 Jan 21;22(3):815. doi: 10.3390/s22030815.
PubMed 35161560Rasti E, Rojhani-Shirazi Z, Ebrahimi N, Sobhan MR. Effects of whole body vibration with exercise therapy versus exercise therapy alone on flexibility, vertical jump height, agility and pain in athletes with patellofemoral pain: a randomized clinical trial. BMC Musculoskelet Disord. 2020 Oct 26;21(1):705. doi: 10.1186/s12891-020-03732-1.
PubMed 33106162Adhama AI, Akindele MO, Ibrahim AA. Effects of variable frequencies of kinesthesia, balance and agility exercise program in adults with knee osteoarthritis: study protocol for a randomized controlled trial. Trials. 2021 Jul 21;22(1):470. doi: 10.1186/s13063-021-05386-3.
PubMed 34289884Shakouri A, Kamali F, Mohamadi M, Nouhi E. Lumbopelvic manipulation alone versus combined with dry needling in physically active patients with patellofemoral pain syndrome: A randomized clinical trial. J Bodyw Mov Ther. 2024 Jan;37:220-225. doi: 10.1016/j.jbmt.2023.11.024. Epub 2023 Nov 25.
PubMed 38432809da Silva Boitrago MV, de Mello NN, Barin FR, Junior PL, de Souza Borges JH, Oliveira M. Effects of proprioceptive exercises and strengthening on pain and functionality for patellofemoral pain syndrome in women: A randomized controlled trial. J Clin Orthop Trauma. 2021 Apr 19;18:94-99. doi: 10.1016/j.jcot.2021.04.017. eCollection 2021 Jul.
PubMed 33996453Clifford AM, Dillon S, Hartigan K, O'Leary H, Constantinou M. The effects of McConnell patellofemoral joint and tibial internal rotation limitation taping techniques in people with Patellofemoral pain syndrome. Gait Posture. 2020 Oct;82:266-272. doi: 10.1016/j.gaitpost.2020.09.010. Epub 2020 Sep 15.
PubMed 32987346
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Agility Training With and Without Foot Mobilization On Pain, Balance and Functional Performance In Patellofemoral Pain Syndrome.
- ClinicalTrials.gov ID
- NCT06674707
- Acronym / sponsor ID
- REC/RCR & AHS/24/0131
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Balance, Functional Performance, Flat foot, Kujala function scale, Patellofemoral pain syndrome, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 7 Jan 2025 (estimated)
- First posted
- 5 Nov 2024 (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) is referred to as peripatellar or retro-patellar pain, which is characterized by alterations in the physical and biomechanical features of the patellofemoral joint. Risk factors for PFPS include: anatomic anomalies, mal-alignment and altered biomechanics of the lower extremity, muscle dysfunction, patellar hypermobility, poor quadriceps, or iliotibial band flexibility, surgery, tight lateral structures, training errors or overuse and trauma. The aim of this study is to compare the effects of foot mobilization with and without agility training on pain, balance and functional performance in patellofemoral pain syndrome.
Detailed description
A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore, Al Rehman Hospital, through convenient purposive sampling technique on 42 patients which will be allocated through using simple randomization into Group A and Group B. Group A will be treated with agility training and foot mobilization in patellofemoral pain syndrome and Group B will be treated with agility training without foot mobilization in patellofemoral pain syndrome thrice a week for 6 weeks. Outcome measures will be conducted through pain (NPRS), Kujala patellofemoral pain scale, Y balance test and Navicular droop test before and after 6 weeks. Data will be analyzed using SPSS software version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agility Training with Foot Mobilization | Experimental | Other: Agility Training with Foot mobilization.Agility Training with Foot Mobilization along with simple conventional treatment |
| Agility Training without Foot Mobilization. | Active comparator | Other: Agility Training without Foot mobilizationAgility training without foot mobilization along with simple conventional treatment. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinical signs of patellofemoral pain syndrome such as retro patellar pain, crepitation, and pain with patellar grinding more than 6 months.
- Both genders of 20-40 years of age.
- Presence of pain on step down from a 25 step or double leg squat and sitting with knee bent greater than 15 min.
- Pain more than 4 on NPRS scale.
- Individual with anterior left/right asymmetries greater than 4 cm on Y balance test
Key exclusion criteria (4 listed)
- History of ligament and meniscal injury.
- History of lower limb fractures.
- History of post-surgical condition of lower limb
- History of systemic, connective tissue or neurologic condition
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 |
|---|---|---|
| Agility Training with Foot mobilization.Also: Simple conventional TreatmentAgility training with foot mobilization with the frequency of 3 sets of 10 repetitions thrice per week for a total six weeks. Pre and post intervention values will be taken on 1st day and after six weeks. Agility training includes side stepping, braiding activities, and front and back crossover steps during forward ambulation, shuttle walking, multiple changes in direction during walking on therapist command. TJM is a grade III Maitland technique and is applied with a high amplitude from the end range and 1s of vibration in the middle range of the joint through a linear motion to where tissue resistance is felt in the prone position, the patient is supported by a towel placed under the foot. Two sets of 5 min total were performed for 6weeks. | Other | Agility Training with Foot Mobilization |
| Agility Training without Foot mobilizationAlso: Simple Conventional TreatmentAgility training includes side stepping, braiding activities, and front and back crossover steps during forward ambulation, shuttle walking, multiple changes in direction during walking on therapist command. Comprising of Hot pack and TENS for 10 minutes and Ultrasound for 5 minutes . Comprising of conventional exercises were given for 3 sessions per week for 6 weeks. It includes semi squat, quadriceps isometric, terminal knee extension with elastic band, terminal knee extension in supine position, and adductor squeeze in crook lying (squeeze the ball). | Other | Agility Training without Foot Mobilization. |
Primary outcome
Numeric Pain Rating Scale (NPRS):
Time frame: 6 weeks
The outcome was the 11-point NPRS to measure pain intensity. The NPRS defines pain intensity from 0 to 10 points, with 0 and 10 points indicating no pain and the most severe pain respectively. The reported test-retest reliability (intraclass correlation coefficient [ICC]) was 0.76, demonstrating it to be a good indicator of pain intensity.
Kujala Patellofemoral Pain Scale
Time frame: 6 weeks
Anterior knee pain scale is frequently referred as Kujala scale. It's a 13 item questionnaire including different items on pain related to function and activities. The items assessed in the questionnaire are patellar subluxation, claudication, pain, walking, climbing stairs and prolonged sitting with the knees flexed. It has a score from 0 to 100 points, where 100 means without pain and functional limitations and 0 means constant pain and various functional limitations.
Y Balance Test
Time frame: 6 weeks
The YBT assesses the balance by challenging his postural control system in 3 (anterior, posteromedial, and posterolateral) of the 8 SEBT (star excursion balance test) directions and has been advocated as a method for assessing dynamic balance (requires strength, flexibility and proprioception). The Y balance score was calculated by dividing the sum of the maximum reach distance in the anterior (A), posteromedial (PM), and posterolateral (PL) directions by 3 times the limb length (LL) of the individual, then multiplied by 100.
Navicular Droop Test
Time frame: 6 weeks
Position the patient in standing so there is full weight-bearing through the lower extremity and ensure the foot is in the subtalar joint neutral position ("talar head congruent"). Mark the most prominent part of the navicular tuberosity and measure its distance from the supporting surface floor or step. Ask the patient to relax and then measure the amount of sagittal plane excursion of the navicular with a ruler. Alternatively, the test can also be performed in reverse, measuring from relaxed position up to talar neutral in standing postion. Many clinicians also choose to perform this test by marking the start and end position of the navicular on an index card placed along the inside of the foot and then measure the change with a ruler. The ICC2,1 values in the sitting and standing positions were 0.93 and 0.95, respectively, indicating significantly high inter-rater reliability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 32904777Luza LP, Luza M, Santos GM. Patellofemoral Pain Syndrome Modifies the Movement of the Rearfoot, but It Does Not Alter Plantar Pressure Distribution. Rev Bras Ortop (Sao Paulo). 2020 Aug;55(4):419-425. doi: 10.1055/s-0039-1698802. Epub 2019 Dec 13.
- Background: PubMed 35161560Gomez Carrion A, de Los Angeles Atin Arratibel M, Morales Lozano MR, Martinez Sebastian C, de la Cruz Torres B, Sanchez-Gomez R. Kinematic Effect on the Navicular Bone with the Use of Rearfoot Varus Wedge. Sensors (Basel). 2022 Jan 21;22(3):815. doi: 10.3390/s22030815.
- Background: PubMed 33106162Rasti E, Rojhani-Shirazi Z, Ebrahimi N, Sobhan MR. Effects of whole body vibration with exercise therapy versus exercise therapy alone on flexibility, vertical jump height, agility and pain in athletes with patellofemoral pain: a randomized clinical trial. BMC Musculoskelet Disord. 2020 Oct 26;21(1):705. doi: 10.1186/s12891-020-03732-1.
- Background: PubMed 34289884Adhama AI, Akindele MO, Ibrahim AA. Effects of variable frequencies of kinesthesia, balance and agility exercise program in adults with knee osteoarthritis: study protocol for a randomized controlled trial. Trials. 2021 Jul 21;22(1):470. doi: 10.1186/s13063-021-05386-3.
- Background: PubMed 38432809Shakouri A, Kamali F, Mohamadi M, Nouhi E. Lumbopelvic manipulation alone versus combined with dry needling in physically active patients with patellofemoral pain syndrome: A randomized clinical trial. J Bodyw Mov Ther. 2024 Jan;37:220-225. doi: 10.1016/j.jbmt.2023.11.024. Epub 2023 Nov 25.
- Background: PubMed 33996453da Silva Boitrago MV, de Mello NN, Barin FR, Junior PL, de Souza Borges JH, Oliveira M. Effects of proprioceptive exercises and strengthening on pain and functionality for patellofemoral pain syndrome in women: A randomized controlled trial. J Clin Orthop Trauma. 2021 Apr 19;18:94-99. doi: 10.1016/j.jcot.2021.04.017. eCollection 2021 Jul.
- Background: PubMed 32987346Clifford AM, Dillon S, Hartigan K, O'Leary H, Constantinou M. The effects of McConnell patellofemoral joint and tibial internal rotation limitation taping techniques in people with Patellofemoral pain syndrome. Gait Posture. 2020 Oct;82:266-272. doi: 10.1016/j.gaitpost.2020.09.010. Epub 2020 Sep 15.
- Individual participant dataSharing planned: No
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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.
Ali Raza, MS-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agility Training with Foot mobilization. and Agility Training without Foot mobilization in people with Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Nov 2024. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS): (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06674707, which also lists 7 linked publications.
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 5 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.