Anterior Knee Pain SyndromeNCT06241053
Effects of Multimodal Physical Therapy With and Without McConnell Taping in Patients With Anterior Knee Pain.
A study testing Multimodal therapy with McConnell taping and Multimodal therapy without McConnell taping in people with Anterior Knee Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to determine the effect Multimodal physical therapy with and without McConnell taping on pain, functional limitation and severity of symptoms in patients with anterior knee pain. Read more about this study
- Who is it for?
- Ages 17 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- Multimodal therapy with McConnell taping and Multimodal therapy without McConnell taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Nov 2023to 5 Feb 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 17 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 17-35 years, both male and female.
- Unilateral or bilateral pain lasting for more than 2-3 months.
- Diagnosed with patellofemoral pain by orthopedic surgeon through clinical and radiological findings.
- Positive patellofemoral grinding test, negative McCurry test and full knee range of motion.
- Pain grade 3-6 by Visual Analogue Scale (VAS).
- Pain at least in two of these positions: sitting for long time with knee bends, going up and down the stairs, squatting and running, kneeling.
Who cannot join
- History of ligament sprain, meniscal injury, knee fracture, patellar dislocation and knee osteoarthritis.
- True knee joint locking or giving away and tibial or iliotibial track tendinopathy.
- Pregnancy.
- Developmental dysplasia of hip and undergoing any medical treatment.
- Spinal surgery and neurological disorders.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Usman Srawr
Lahore, Punjab Province, 54600
Usman Sarwar, FCPS Ortho, 03004280554, onlyawan@yahoo.com
Usman Srawar, FCPS Ortho, 03326099065, onlyawan@yahoo.com
About this study
This study aims to determine the effect Multimodal physical therapy with and without McConnell taping on pain, functional limitation and severity of symptoms in patients with anterior knee pain.
Read the detailed description
The term "Anterior Knee Pain" is often used interchangeably with "Patellelofemoral Pain Syndrome" (PFPS or " runner's knee" which involves stiffness and pain when patellofemoral joint is loaded with different activities that require prolonged knee flexion, stairs climbing or descending , running, kneeling and squatting. Multimodal therapy and tapping techniques are useful for reducing pain and improving functional activities of patient daily living.
In this randomized clinical trial, Thirty participants with anterior knee pain will be randomly assigned to one of the two intervention groups: Group A: Group A will be treated with multimodal physical therapy program with McConnell taping. Group B: Group B will be treated with multimodal physical therapy program without McConnell taping. Randomization will be performed using a convenient random sampling method via lottery method. Each participant will receive a total of 12 treatment sessions.
over a four-week period. The effects of the interventions will be assessed at the beginning (first session), conclusion (eight session). Participants will be followed up after 4 weeks again. Outcome measures, including pain intensity, functional limitation and severity of symptoms will be evaluating using the Visual Analog Scale (VAS), Lower Extremity Functional Scale (LEFS) and Anterior Knee Pain Scale (AKPS) respectively. Data will be analyzed using SPSS software version 25. Normality of data will be assessed using the Shapiro-wilk test. For within-group comparisons, paired t- test will be used. To compare changes between the groups, the independent t-test will be applied, depending on the data distribution. The analysis of these outcome measures will provide. valuable insights into the impact of the interventions on participants' pain, functional limitation and severity of symptoms.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- Multimodal therapy with McConnell taping, Multimodal therapy without McConnell taping
- Keywords
- Anterior Knee Pain, McConnell taping, Patellofemoral Pain Syndrome.
- 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.
Multimodal therapy with McConnell tapingOther
Multimodal therapy includes core exercises, hip exercises and vastus medialis training.
Core exercises include curls ups, toa taps, side planks, supine straight leg raising, side lying straight leg raising, prone knee flexion, draw foot circles in supine and side lying, prone cobra, hip and knee extension, weight bearing, hip flexion sitting on ball, wight bearing forward and backward on the ball, stairs up on Swiss ball. Hip training includes Hip abduction, Hip external rotation in standing and sitting. VMO muscle strengthening will includes squats with a ball.
Multimodal therapy without McConnell tapingOther
Multimodal therapy without McConnell taping
| Study group | Role | What they receive |
|---|---|---|
| Multimodal therapy with McConnell taping | Experimental | Multimodal therapy includes core exercises, hip exercises and vastus medialis training.
MacConnell taping will be applied during exercise and then nearly for 18 hours according to patient's comfort. Receives: Other: Multimodal therapy with McConnell taping |
| Multimodal therapy without McConnell taping | Experimental | Multimodal therapy includes core exercises, hip exercises and vastus medialis training. Receives: Other: Multimodal therapy without McConnell taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual analog scale is a self-assessing questionnaire comprising 10cm line with 0 representing no pain and 10 is worst pain. Reliability of VAS in patients with anterior knee pain is .60 to .79 for usual pain and .88 for worst pain.
Measured: 4rth week
Lower Extremity Functional Scale
The Lower Extremity Functional Scale is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The score for each task is separated in 5 categories "0" (extreme difficulty or unable to perform activity), "1" (quite a bit of difficulty), "2" (moderate difficulty), "3" (a little bit of difficulty) and "4" (no difficulty). The maximal function is 80 points.
Measured: 4rth week
Anterior Knee Pain Scale
The Anterior Knee pain Scale questionnaire consist of 13 items assessing subjective symptoms and functional limitation of the patients with anterior knee pain. The score ranges from 0 (worst condition) to 100 (normal knee condition, no symptoms and no daily functional restrictions).
Measured: 4rth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start5 Nov 2023
- Primary completion5 Feb 2024 (estimated)
- Study completion5 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Knee 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahtsam Liaqat, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241053
- Sponsor's protocol ID
- REC/RCR & AHS/23/0148
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foroughi 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 30267667Motealleh A, Kordi Yoosefinejad A, Ghoddosi M, Azhdari N, Pirouzi S. Trunk postural control during unstable sitting differs between patients with patellofemoral pain syndrome and healthy people: A cross-sectional study. Knee. 2019 Jan;26(1):26-32. doi: 10.1016/j.knee.2018.10.002. Epub 2018 Nov 22.
PubMed 30472048
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal Physical Therapy With and Without McConnell Taping in Patients With Anterior Knee Pain.
- ClinicalTrials.gov ID
- NCT06241053
- Acronym / sponsor ID
- REC/RCR & AHS/23/0148
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- Anterior Knee Pain, McConnell taping, Patellofemoral Pain Syndrome.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 5 Feb 2024 (estimated)
- Study completion
- 5 Feb 2024 (estimated)
- First posted
- 5 Feb 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.
This study aims to determine the effect Multimodal physical therapy with and without McConnell taping on pain, functional limitation and severity of symptoms in patients with anterior knee pain.
Detailed description
The term "Anterior Knee Pain" is often used interchangeably with "Patellelofemoral Pain Syndrome" (PFPS or " runner's knee" which involves stiffness and pain when patellofemoral joint is loaded with different activities that require prolonged knee flexion, stairs climbing or descending , running, kneeling and squatting. Multimodal therapy and tapping techniques are useful for reducing pain and improving functional activities of patient daily living.
In this randomized clinical trial, Thirty participants with anterior knee pain will be randomly assigned to one of the two intervention groups: Group A: Group A will be treated with multimodal physical therapy program with McConnell taping. Group B: Group B will be treated with multimodal physical therapy program without McConnell taping. Randomization will be performed using a convenient random sampling method via lottery method. Each participant will receive a total of 12 treatment sessions.
over a four-week period. The effects of the interventions will be assessed at the beginning (first session), conclusion (eight session). Participants will be followed up after 4 weeks again. Outcome measures, including pain intensity, functional limitation and severity of symptoms will be evaluating using the Visual Analog Scale (VAS), Lower Extremity Functional Scale (LEFS) and Anterior Knee Pain Scale (AKPS) respectively. Data will be analyzed using SPSS software version 25. Normality of data will be assessed using the Shapiro-wilk test. For within-group comparisons, paired t- test will be used. To compare changes between the groups, the independent t-test will be applied, depending on the data distribution. The analysis of these outcome measures will provide. valuable insights into the impact of the interventions on participants' pain, functional limitation and severity of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal therapy with McConnell taping | Experimental | Other: Multimodal therapy with McConnell tapingMultimodal therapy includes core exercises, hip exercises and vastus medialis training. MacConnell taping will be applied during exercise and then nearly for 18 hours according to patient's comfort. |
| Multimodal therapy without McConnell taping | Experimental | Other: Multimodal therapy without McConnell tapingMultimodal therapy includes core exercises, hip exercises and vastus medialis training. |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 17-35 years, both male and female.
- Unilateral or bilateral pain lasting for more than 2-3 months.
- Diagnosed with patellofemoral pain by orthopedic surgeon through clinical and radiological findings.
- Positive patellofemoral grinding test, negative McCurry test and full knee range of motion.
- Pain grade 3-6 by Visual Analogue Scale (VAS).
Key exclusion criteria (5 listed)
- History of ligament sprain, meniscal injury, knee fracture, patellar dislocation and knee osteoarthritis.
- True knee joint locking or giving away and tibial or iliotibial track tendinopathy.
- Pregnancy.
- Developmental dysplasia of hip and undergoing any medical treatment.
- Spinal surgery and neurological disorders.
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 |
|---|---|---|
| Multimodal therapy with McConnell tapingMultimodal therapy includes core exercises, hip exercises and vastus medialis training. Core exercises include curls ups, toa taps, side planks, supine straight leg raising, side lying straight leg raising, prone knee flexion, draw foot circles in supine and side lying, prone cobra, hip and knee extension, weight bearing, hip flexion sitting on ball, wight bearing forward and backward on the ball, stairs up on Swiss ball. Hip training includes Hip abduction, Hip external rotation in standing and sitting. VMO muscle strengthening will includes squats with a ball. | Other | Multimodal therapy with McConnell taping |
| Multimodal therapy without McConnell tapingMultimodal therapy without McConnell taping | Other | Multimodal therapy without McConnell taping |
Primary outcome
Visual Analog Scale
Time frame: 4rth week
Visual analog scale is a self-assessing questionnaire comprising 10cm line with 0 representing no pain and 10 is worst pain. Reliability of VAS in patients with anterior knee pain is .60 to .79 for usual pain and .88 for worst pain.
Lower Extremity Functional Scale
Time frame: 4rth week
The Lower Extremity Functional Scale is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The score for each task is separated in 5 categories "0" (extreme difficulty or unable to perform activity), "1" (quite a bit of difficulty), "2" (moderate difficulty), "3" (a little bit of difficulty) and "4" (no difficulty). The maximal function is 80 points.
Anterior Knee Pain Scale
Time frame: 4rth week
The Anterior Knee pain Scale questionnaire consist of 13 items assessing subjective symptoms and functional limitation of the patients with anterior knee pain. The score ranges from 0 (worst condition) to 100 (normal knee condition, no symptoms and no daily functional restrictions).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- 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 30472048Motealleh A, Kordi Yoosefinejad A, Ghoddosi M, Azhdari N, Pirouzi S. Trunk postural control during unstable sitting differs between patients with patellofemoral pain syndrome and healthy people: A cross-sectional study. Knee. 2019 Jan;26(1):26-32. doi: 10.1016/j.knee.2018.10.002. Epub 2018 Nov 22.
- Individual participant dataSharing planned: No
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Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
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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.
Ahtsam Liaqat 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 Multimodal therapy with McConnell taping and Multimodal therapy without McConnell taping in people with Anterior Knee 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 5 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saba Rafique, MS (03034045433, saba.rafique@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 4rth 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 NCT06241053, which also lists 2 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 Feb 2024.