Patellofemoral Pain SyndromePhase 1/2NCT06439251
Effects of Mulligan Technique With or Without Diclofenac Phonophoresis on Patellofemoral Pain Syndrome.
A Phase 1/2 study testing Group 1 and Group 2 in people with Patellofemoral Pain Syndrome, run by University of Lahore at 1 site in Pakistan.
Trial summary
The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women. the effectiveness of Mulligan technique with or without diclofenac phonophoresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome is known… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Group 1 and Group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Oct 2023to 20 Jul 2025
- Phase
- Phase 1/2
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patients of age range 20-45 years and both genders (Rehman, 2021 #171)
- Unilateral anterior knee pain persisting for over two months, referred by orthopedic (Rehman, 2021 #171)
- Pain scoring rate on numeric pain rating scale (NPRS) >3 during at least two activities (Rehman, 2021 #171)
- Patients with positive Clarke's test/ Patellar grind test (Rehman, 2021 #171)
- Pain while going up and down stairs, when sitting with knees flexed and with squatting, kneeling or returning from squat. (Powers, 2017 #172)
Who cannot join
- • Patients with other knee pathologies; meniscus tears, bursitis, patellar tendon injury, ligamentous injury
- Degenerative joint disorders; knee osteoarthritis, rheumatoid arthritis etc.
- Patellofemoral dislocation and / or frequent subluxation.
- Patients having undergone lower extremity surgery
- Those taking any pain medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mulligan Technique With or Without Diclofenac Phonophoresis on Pain, Range of Motion and Functional Disability of Knee Joint in Patients With Patellofemoral Pain Syndrome
The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women. the effectiveness of Mulligan technique with or without diclofenac phonophoresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome is known little. This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises will be administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) will be assessed by a blinded assessor at baseline and study completion.
Read the detailed description
Background: The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women without any structural changes such as increased Q-angle or significant pathological changes in articular cartilage.
Objective: To evaluate the effectiveness of Mulligan technique with or without diclofenac phonopheresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome.
Methodology: This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises were administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) were assessed by a blinded assessor at baseline and study completion.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Group 1, Group 2
- Keywords
- Patellofemoral Pain Syndrome,, Mulligan mobilization, Phonophoresis, diclofenac
- 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.
Group 1Combination product
The treatment included TENS therapy, hot pack application, stretching exercises, isometric strengthening, straight leg raises with traction, and tibial gliding techniques. Participants in Group A also received Phonophoresis as an experimental technique.
Group 2Combination product
The treatment included routine physiotherapy with TENS, hot pack application, stretching exercises, isometric strengthening, straight leg raises with traction, and tibial gliding techniques.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Phonophoresis | Experimental | The participants randomly allocated in Group A were receive the Phonophoresis (Ultrasound with Diclofenac gel for 5 minutes and intensities 1 MHz and 1.5 W/cm² pulsed waves was used in the therapy sessions on affected knee with diclofenac gel on ultrasound head) as experimental technique Receives: Combination Product: Group 1 |
| Mulligan Technique | Active comparator | The treatment involved routine physiotherapy with TENS at 80 Hz and a pulse duration of 50-100 μs, followed by a 15-minute hot pack. It also included stretching exercises for the hamstring and calf muscles, isometric strengthening of the quadriceps and VMO, straight leg raises with traction, and tibial gliding techniques. The MWM technique consisted of SLR with traction, repeated 10 times with 3 sets and a 1-minute interval in between. Receives: Combination Product: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: 4 weeks
KOOS-PF Scale
KOOS-PF is a subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that specifically measures symptoms and function related to patellofemoral pain and osteoarthritis. It was developed to provide a more detailed assessment in this specific knee condition. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. This direction, 100 indicating no problems.
Measured: 4 weeks
Universal Goniometer
It has a scale for the measurement of the angle. The scale can extend from 0 to 180 degrees for half-circle models or 0 to 360 degrees for full-circle models.
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 posted3 Jun 2024
- Study start18 Oct 2023
- Primary completion15 Jun 2025
- Study completion20 Jul 2025
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 University of LahoreThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zunaira saeed, University of Lahore
- Investigators
- Zunaira Saeed, Masters, Principal investigator, University of LahoreUmber Nawaz, PhD Scholar, Principal investigator, University of LahoreAshfaq Ahmad, PhD, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439251
- Sponsor's protocol ID
- REC-UOL-546-10-2023
- Status last verified
- Aug 2025
- First submitted
- 27 Feb 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mulligan Technique With or Without Diclofenac Phonophoresis on Pain, Range of Motion and Functional Disability of Knee Joint in Patients With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT06439251
- Acronym / sponsor ID
- REC-UOL-546-10-2023
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral Pain Syndrome,, Mulligan mobilization, Phonophoresis, diclofenac
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 3 Jun 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.
The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women. the effectiveness of Mulligan technique with or without diclofenac phonophoresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome is known little. This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises will be administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) will be assessed by a blinded assessor at baseline and study completion.
Detailed description
Background: The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women without any structural changes such as increased Q-angle or significant pathological changes in articular cartilage.
Objective: To evaluate the effectiveness of Mulligan technique with or without diclofenac phonopheresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome.
Methodology: This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises were administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) were assessed by a blinded assessor at baseline and study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Phonophoresis | Experimental | Combination Product: Group 1The participants randomly allocated in Group A were receive the Phonophoresis (Ultrasound with Diclofenac gel for 5 minutes and intensities 1 MHz and 1.5 W/cm² pulsed waves was used in the therapy sessions on affected knee with diclofenac gel on ultrasound head) as experimental technique |
| Mulligan Technique | Active comparator | Combination Product: Group 2The treatment involved routine physiotherapy with TENS at 80 Hz and a pulse duration of 50-100 μs, followed by a 15-minute hot pack. It also included stretching exercises for the hamstring and calf muscles, isometric strengthening of the quadriceps and VMO, straight leg raises with traction, and tibial gliding techniques. The MWM technique consisted of SLR with traction, repeated 10 times with 3 sets and a 1-minute interval in between. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patients of age range 20-45 years and both genders (Rehman, 2021 #171)
Key exclusion criteria (5 listed)
- • Patients with other knee pathologies; meniscus tears, bursitis, patellar tendon injury, ligamentous injury
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 |
|---|---|---|
| Group 1The treatment included TENS therapy, hot pack application, stretching exercises, isometric strengthening, straight leg raises with traction, and tibial gliding techniques. Participants in Group A also received Phonophoresis as an experimental technique. | Combination product | Diclofenac Phonophoresis |
| Group 2The treatment included routine physiotherapy with TENS, hot pack application, stretching exercises, isometric strengthening, straight leg raises with traction, and tibial gliding techniques. | Combination product | Mulligan Technique |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 weeks
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
KOOS-PF Scale
Time frame: 4 weeks
KOOS-PF is a subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that specifically measures symptoms and function related to patellofemoral pain and osteoarthritis. It was developed to provide a more detailed assessment in this specific knee condition. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. This direction, 100 indicating no problems.
Universal Goniometer
Time frame: 4 weeks
It has a scale for the measurement of the angle. The scale can extend from 0 to 180 degrees for half-circle models or 0 to 360 degrees for full-circle models.
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 8 Aug 2025.
- Individual participant dataSharing planned: Yes. After the completion of the study
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.
Zunaira Saeed, Masters principal investigator
University of Lahore
Umber Nawaz, PhD Scholar principal investigator
University of Lahore
Ashfaq Ahmad, PhD study chair
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Group 1 and Group 2 in people with Patellofemoral Pain Syndrome, run by University of Lahore 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 5 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: finished, as of the sponsor's last update on 8 Aug 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Numeric Pain Rating Scale (time frame: 4 weeks). 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 8 Aug 2025.