Patellofemoral Pain SyndromeNCT05924607
Clamshells Exercise and Vastrus Medialis Oblique Strengthening Exercise on Patellofemoral Pain Syndrome
A study testing Standard clamshells method and Targeted VMO strengthening in people with Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
PFPS, also known as patellofemoral pain syndrome, is a prevalent musculoskeletal condition that primarily affects adolescents and young adults. When engaging in various activities, such as stair climbing, running, jumping, kneeling, or prolonged sitting, it is characterized by aching pain in the peripatellar region. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Standard clamshells method and Targeted VMO strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Nov 2022to 30 Aug 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 40years
- Both Genders (male \& female)
- Unilateral or bilateral knee pain for at least 1-3 month,
- Pain provoked by at least 3 functional activities ( ascending/descending stairs, kneeling, jumping, running, squatting,hopping,prolonged sitting)
- Average NPRS score above 3 out of 10 during previous week.
- Knee pain on stepping down from 20cm step height.
Who cannot join
- Previous history of patellar subluxation or dislocation
- Knee surgery within previous year
- History of knee joint pathologies ( meniscus,ligament injuries,)
- Any fracture of lower extremity
- Massive effusion/any abnormal deformity of knee joint.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ittefaq Hospital
Lahore, Punjab Province, 54000
sidra khan, MSNMPT, 03004132720, sidra_khan5544@yahoo.com
About this study
Official title: Comparative Effects of Clamshells Exercise and Vastrus Medialis Oblique Strengthening Exercise on Patellofemoral Pain Syndrome
PFPS, also known as patellofemoral pain syndrome, is a prevalent musculoskeletal condition that primarily affects adolescents and young adults. When engaging in various activities, such as stair climbing, running, jumping, kneeling, or prolonged sitting, it is characterized by aching pain in the peripatellar region. Any disruption of these would result in abnormal PFJ overloading. Normal patellar tracking on the trochlea groove relies on the coordination and balance of many structures, including soft tissues, muscles, tendons, ligaments, and the shape of articular surfaces around the knee joint. Research in a variety of fields has received support the therapeutic exercise known as "clamshells" for stabilizing the pelvis by strengthening the hip abductors and external rotators.VMO strengthening exercises are also essential in keeping the patella in the trochlear groove and lowering the lateral vector force on the patellofemoral joint. This research aims to evaluate the effects of clamshells exercise and Vastrus medialis oblique strengthening exercise in patients with Patellofemoral pain syndrome.
The study would be randomized clinical trial. Total fourty two subjects will be assigned randomly by using lottery method into two groups. Group A will be given clamshell exercise with baseline treatment while Group B will receive targeted vastrus medialis oblique strengthening exercise with baseline treatment. After confirmation of diagnosis with physical examination as well as zohlar's test /20 cm step down test are recommended. Numeric pain rating scale (NPRS) and Lower extremity functional scale (LEFS) would be used as an outcome measure tools for pain and functional limitation respectively. Measurements will be taken at (Baseline and at the end of treatment session). The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0. Parametric/non-parametric tests will be applied after testing normality of data.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Standard clamshells method, Targeted VMO strengthening
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard clamshells methodOther
The patient is asked to lie in a side-lying position with the weak limb up, both hips flexed at 45°, the knees flexed at 90°, and neither the feet nor back not in contact with the wall. Keeping both their heels and the first metatarsal head together, the patient separated their knees and rotated the weak limb upward. The patients is instructed not to tip it backward and to hold the pelvis in a neutral position
Targeted VMO strengtheningOther
Targeted VMO strengthening The patient is asked to lie in a supine lying position with arm next to the body. After that asked the patient to perform SLR exercise in an external hip rotation with the simultaneous contraction of the ankle dorsiflexors. Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions
| Study group | Role | What they receive |
|---|---|---|
| Standard clamshells method | Experimental | The patient is asked to lie in a side-lying position with the weak limb up, both hips flexed at 45°, the knees flexed at 90°, and neither the feet nor back not in contact with the wall. Keeping both their heels and the first metatarsal head together, the patient separated their knees and rotated the weak limb upward. The patients is instructed not to tip it backward and to hold the pelvis in a neutral position.Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions) Receives: Other: Standard clamshells method |
| Targeted VMO strengthening | Experimental | The patient is asked to lie in a supine lying position with arm next to the body. After that asked the patient to perform SLR exercise in an external hip rotation with the simultaneous contraction of the ankle dorsiflexors. Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions Receives: Other: Targeted VMO strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
numeric pain rating scale(NPRS) is used to measure intensity of pain.Score ranges from 0-10.Higher values mean greater level o pain.
Measured: Baseline to 6th week
Functional disability
The lower Extremity Functional Scale (LEFS) is used to measure the functional status of the lower extremity. score ranges from 0-80. lower values mean greater functional limitation.
Measured: Baseline to 6th week
Muscle strength
Sphygmomanometer is used to measure muscle strength. higher readings on sphygmomanometer represents better muscle strength.
Measured: Baseline to 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start14 Nov 2022
- Primary completion24 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Rabiya Noor, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924607
- Sponsor's protocol ID
- REC/RCR & AHS/23/0101
- Status last verified
- Jun 2023
- First submitted
- 18 Apr 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hott A, Brox JI, Pripp AH, Juel NG, Liavaag S. Patellofemoral pain: One year results of a randomized trial comparing hip exercise, knee exercise, or free activity. Scand J Med Sci Sports. 2020 Apr;30(4):741-753. doi: 10.1111/sms.13613. Epub 2020 Jan 5.
PubMed 31846113Foroughi F, Sobhani S, Yoosefinejad AK, Motealleh A. Added Value of Isolated Core Postural Control Training on Knee Pain and Function in Women With Patellofemoral Pain Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Feb;100(2):220-229. doi: 10.1016/j.apmr.2018.08.180. Epub 2018 Sep 26.
PubMed 30267667Azab AR, Abdelbasset WK, Basha MA, Mahmoud WS, Elsayed AE, Saleh AK, Elnaggar RK. Incorporation of Pilates-based core strengthening exercises into the rehabilitation protocol for adolescents with patellofemoral pain syndrome: a randomized clinical trial. Eur Rev Med Pharmacol Sci. 2022 Feb;26(4):1091-1100. doi: 10.26355/eurrev_202202_28098.
PubMed 35253163
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Clamshells Exercise and Vastrus Medialis Oblique Strengthening Exercise on Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT05924607
- Acronym / sponsor ID
- REC/RCR & AHS/23/0101
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 24 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 29 Jun 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.
PFPS, also known as patellofemoral pain syndrome, is a prevalent musculoskeletal condition that primarily affects adolescents and young adults. When engaging in various activities, such as stair climbing, running, jumping, kneeling, or prolonged sitting, it is characterized by aching pain in the peripatellar region. Any disruption of these would result in abnormal PFJ overloading. Normal patellar tracking on the trochlea groove relies on the coordination and balance of many structures, including soft tissues, muscles, tendons, ligaments, and the shape of articular surfaces around the knee joint. Research in a variety of fields has received support the therapeutic exercise known as "clamshells" for stabilizing the pelvis by strengthening the hip abductors and external rotators.VMO strengthening exercises are also essential in keeping the patella in the trochlear groove and lowering the lateral vector force on the patellofemoral joint. This research aims to evaluate the effects of clamshells exercise and Vastrus medialis oblique strengthening exercise in patients with Patellofemoral pain syndrome.
The study would be randomized clinical trial. Total fourty two subjects will be assigned randomly by using lottery method into two groups. Group A will be given clamshell exercise with baseline treatment while Group B will receive targeted vastrus medialis oblique strengthening exercise with baseline treatment. After confirmation of diagnosis with physical examination as well as zohlar's test /20 cm step down test are recommended. Numeric pain rating scale (NPRS) and Lower extremity functional scale (LEFS) would be used as an outcome measure tools for pain and functional limitation respectively. Measurements will be taken at (Baseline and at the end of treatment session). The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0. Parametric/non-parametric tests will be applied after testing normality of data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard clamshells method | Experimental | Other: Standard clamshells methodThe patient is asked to lie in a side-lying position with the weak limb up, both hips flexed at 45°, the knees flexed at 90°, and neither the feet nor back not in contact with the wall. Keeping both their heels and the first metatarsal head together, the patient separated their knees and rotated the weak limb upward. The patients is instructed not to tip it backward and to hold the pelvis in a neutral position.Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions) |
| Targeted VMO strengthening | Experimental | Other: Targeted VMO strengtheningThe patient is asked to lie in a supine lying position with arm next to the body. After that asked the patient to perform SLR exercise in an external hip rotation with the simultaneous contraction of the ankle dorsiflexors. Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 40years
- Both Genders (male \& female)
- Unilateral or bilateral knee pain for at least 1-3 month,
- Pain provoked by at least 3 functional activities ( ascending/descending stairs, kneeling, jumping, running, squatting,hopping,prolonged sitting)
- Average NPRS score above 3 out of 10 during previous week.
Key exclusion criteria (5 listed)
- Previous history of patellar subluxation or dislocation
- Knee surgery within previous year
- History of knee joint pathologies ( meniscus,ligament injuries,)
- Any fracture of lower extremity
- Massive effusion/any abnormal deformity of knee joint.
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 |
|---|---|---|
| Standard clamshells methodThe patient is asked to lie in a side-lying position with the weak limb up, both hips flexed at 45°, the knees flexed at 90°, and neither the feet nor back not in contact with the wall. Keeping both their heels and the first metatarsal head together, the patient separated their knees and rotated the weak limb upward. The patients is instructed not to tip it backward and to hold the pelvis in a neutral position | Other | Standard clamshells method |
| Targeted VMO strengtheningTargeted VMO strengthening The patient is asked to lie in a supine lying position with arm next to the body. After that asked the patient to perform SLR exercise in an external hip rotation with the simultaneous contraction of the ankle dorsiflexors. Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions | Other | Targeted VMO strengthening |
Primary outcome
Pain intensity
Time frame: Baseline to 6th week
numeric pain rating scale(NPRS) is used to measure intensity of pain.Score ranges from 0-10.Higher values mean greater level o pain.
Functional disability
Time frame: Baseline to 6th week
The lower Extremity Functional Scale (LEFS) is used to measure the functional status of the lower extremity. score ranges from 0-80. lower values mean greater functional limitation.
Muscle strength
Time frame: Baseline to 6th week
Sphygmomanometer is used to measure muscle strength. higher readings on sphygmomanometer represents better muscle strength.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Background: PubMed 31846113Hott A, Brox JI, Pripp AH, Juel NG, Liavaag S. Patellofemoral pain: One year results of a randomized trial comparing hip exercise, knee exercise, or free activity. Scand J Med Sci Sports. 2020 Apr;30(4):741-753. doi: 10.1111/sms.13613. Epub 2020 Jan 5.
- Background: PubMed 30267667Foroughi F, Sobhani S, Yoosefinejad AK, Motealleh A. Added Value of Isolated Core Postural Control Training on Knee Pain and Function in Women With Patellofemoral Pain Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Feb;100(2):220-229. doi: 10.1016/j.apmr.2018.08.180. Epub 2018 Sep 26.
- Background: PubMed 35253163Azab AR, Abdelbasset WK, Basha MA, Mahmoud WS, Elsayed AE, Saleh AK, Elnaggar RK. Incorporation of Pilates-based core strengthening exercises into the rehabilitation protocol for adolescents with patellofemoral pain syndrome: a randomized clinical trial. Eur Rev Med Pharmacol Sci. 2022 Feb;26(4):1091-1100. doi: 10.26355/eurrev_202202_28098.
- 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. This study is not recruiting at the moment.
Dr.Rabiya Noor, Phd 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 Standard clamshells method and Targeted VMO strengthening 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 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 29 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline to 6th week). 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?
On the ClinicalTrials.gov record for NCT05924607, which also lists 3 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 29 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.