Patellofemoral Pain SyndromeNCT07273110
Extracorporeal Shock Wave Therapy in Patellofemoral Pain Syndrome
A study testing Home-based Exercise Program and Radial Extracorporeal Shock Wave Therapy (ESWT) in people with Patellofemoral Pain Syndrome, run by Uğur Can Yalaki at 1 site in Turkey (Türkiye).
Trial summary
Patellofemoral pain syndrome (PFPS) is a common cause of anterior knee pain and functional limitations in physically active individuals. Exercise-based rehabilitation is considered the primary treatment approach, yet a proportion of patients experience persistent symptoms. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Home-based Exercise Program and Radial Extracorporeal Shock Wave Therapy (ESWT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2021to 6 Sep 2021
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 45 years.
- Clinical diagnosis of patellofemoral pain syndrome (PFPS) characterized by anterior or retropatellar knee pain lasting at least 8 weeks.
- Pain provoked during at least two of the following activities: running, jumping, squatting, stair climbing, or prolonged sitting.
- Worst knee pain score of ≥3 on the Visual Analog Scale (0-10).
- Ability to understand and follow the exercise program and assessment procedures.
- Provided written informed consent.
Who cannot join
- Evidence of intra-articular knee pathology other than grade 1-2 meniscal changes or grade 1 chondromalacia patella on MRI.
- Clinical signs of patellar instability.
- Localized tenderness indicating alternative diagnoses (e.g., patellar tendinopathy, iliotibial band syndrome, pes anserine bursitis).
- History of knee surgery on the affected side.
- Intra-articular injections (e.g., corticosteroids, hyaluronic acid, PRP) within the past 6 months.
- Neurological or rheumatological disorders affecting the lower extremity.
- Active infection, open wound, tumor, or severe dermatological condition at or near the ESWT application site.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludağ University Sports Medicine Clinic
Bursa, Nilüfer, 16059
About this study
Official title: Effectiveness of Extracorporeal Shock Wave Therapy in Patellofemoral Pain Syndrome: A Randomized Controlled Trial
Patellofemoral pain syndrome (PFPS) is a common cause of anterior knee pain and functional limitations in physically active individuals. Exercise-based rehabilitation is considered the primary treatment approach, yet a proportion of patients experience persistent symptoms. Extracorporeal shock wave therapy (ESWT) is a non-invasive modality that may reduce pain through neuromodulation and tissue-level biological responses.
This randomized controlled trial evaluated the effects of ESWT on knee pain and function in adults with PFPS. Thirty-six participants aged 18-45 years were randomly assigned to one of three groups: Exercise, Exercise plus ESWT, or ESWT alone. The exercise program consisted of home-based hip and knee strengthening performed at least three times per week for four weeks. ESWT was administered as five radial shock wave sessions at five-day intervals around the peripatellar soft tissues.
Read more
Outcomes included worst knee pain measured by the Visual Analogue Scale and functional status measured by the Kujala Patellofemoral Score at baseline, week 1, and week 8. All groups demonstrated significant improvements over time, with no significant differences between groups. The treatment was well tolerated.
This trial was retrospectively registered after patient enrollment was completed.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Home-based Exercise Program, Radial Extracorporeal Shock Wave Therapy (ESWT)
- Keywords
- patellofemoral pain syndrome, extracorporeal shock-wave therapy, exercise therapy
- 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.
Home-based Exercise ProgramBehavioural
A structured home-based exercise program targeting hip and knee musculature. The program included warm-up, stretching, and progressive strengthening for the quadriceps, hip abductors, hip external rotators, and core stability muscles. Participants were instructed to perform the program at least three times per week for 4 weeks. Exercise progression and technique were explained individually. Adherence was monitored with weekly exercise diaries and telephone follow-up.
Radial Extracorporeal Shock Wave Therapy (ESWT)Device
Five sessions of radial extracorporeal shock wave therapy delivered at 5-day intervals using the Chattanooga Intelect® RPW device. Each session consisted of 2000 pulses at 1.8-2.0 bar pressure and 8 Hz frequency. Treatment was applied to the peripatellar soft tissues (medial and lateral retinaculum and infrapatellar fat pad), while avoiding direct application over the patellar tendon. Pressure was adjusted based on participant tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Participants performed a structured home-based exercise program targeting hip and knee musculature. The program included warm-up, stretching, and progressive strengthening exercises for the quadriceps, hip abductors, hip external rotators, and core stability muscles. Participants were instructed to complete the program at least three times per week for 4 weeks. Exercise technique and progression guidelines were explained in person, and adherence was monitored using weekly exercise diaries and telephone follow-up. Receives: Behavioral: Home-based Exercise Program |
| ESWT | Experimental | Participants received five sessions of radial extracorporeal shock wave therapy (ESWT) administered at 5-day intervals. Treatment was delivered using the Chattanooga Intelect® RPW device with 2000 pulses per session at 1.8-2.0 bar pressure and 8 Hz frequency. Stimulation was applied to the peripatellar soft tissues, including the medial and lateral patellofemoral retinaculum and the infrapatellar fat pad, while avoiding direct application over the patellar tendon. Pressure was progressively increased across sessions based on tolerance. Receives: Device: Radial Extracorporeal Shock Wave Therapy (ESWT) |
| Exercise + ESWT | Experimental | Participants performed the same home-based strengthening program as the Exercise group (hip and knee strengthening, ≥3 sessions/week for 4 weeks). In addition, they received five sessions of radial extracorporeal shock wave therapy (2000 pulses; 1.8-2.0 bar; 8 Hz) at 5-day intervals applied to the peripatellar soft tissues while avoiding the patellar tendon. Receives: Behavioral: Home-based Exercise Program; Device: Radial Extracorporeal Shock Wave Therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale, 0-10
The Visual Analog Scale (VAS) was used to assess the worst knee pain experienced in the previous week during daily or functional activities. Participants rated their pain on a 0-10 scale, where 0 represents no pain and 10 represents the worst imaginable pain. Pain intensity was recorded at baseline prior to intervention, at one week, and at eight weeks after the treatment to evaluate short- and mid-term treatment effects.
Measured: Baseline, Week 1, Week 8
Secondary outcomes (1)
Kujala Patellofemoral Score
The Kujala Anterior Knee Pain Scale was used to evaluate knee-specific functional status. This validated questionnaire consists of 13 items assessing pain, functional limitations, and activities such as running, stair climbing, prolonged sitting, and squatting. Total scores range from 0 to 100, with higher scores indicating better function. Assessments were completed at baseline, at one week, and at eight weeks after the treatment to determine functional improvement over time.
Measured: Baseline, Week 1, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start4 Jan 2021
- Primary completion5 Jul 2021
- Study completion6 Sep 2021
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.
- 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uğur Can Yalaki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Uğur Can Yalaki, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273110
- Sponsor's protocol ID
- PFPS-ESWT-2021
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extracorporeal Shock Wave Therapy in Patellofemoral Pain Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07273110
- Acronym / sponsor ID
- PFPS-ESWT-2021
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- patellofemoral pain syndrome, extracorporeal shock-wave therapy, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Uğur Can YalakiUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 9 Dec 2025 (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 a common cause of anterior knee pain and functional limitations in physically active individuals. Exercise-based rehabilitation is considered the primary treatment approach, yet a proportion of patients experience persistent symptoms. Extracorporeal shock wave therapy (ESWT) is a non-invasive modality that may reduce pain through neuromodulation and tissue-level biological responses.
This randomized controlled trial evaluated the effects of ESWT on knee pain and function in adults with PFPS. Thirty-six participants aged 18-45 years were randomly assigned to one of three groups: Exercise, Exercise plus ESWT, or ESWT alone. The exercise program consisted of home-based hip and knee strengthening performed at least three times per week for four weeks. ESWT was administered as five radial shock wave sessions at five-day intervals around the peripatellar soft tissues.
Outcomes included worst knee pain measured by the Visual Analogue Scale and functional status measured by the Kujala Patellofemoral Score at baseline, week 1, and week 8. All groups demonstrated significant improvements over time, with no significant differences between groups. The treatment was well tolerated.
This trial was retrospectively registered after patient enrollment was completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: Home-based Exercise ProgramParticipants performed a structured home-based exercise program targeting hip and knee musculature. The program included warm-up, stretching, and progressive strengthening exercises for the quadriceps, hip abductors, hip external rotators, and core stability muscles. Participants were instructed to complete the program at least three times per week for 4 weeks. Exercise technique and progression guidelines were explained in person, and adherence was monitored using weekly exercise diaries and telephone follow-up. |
| ESWT | Experimental | Device: Radial Extracorporeal Shock Wave Therapy (ESWT)Participants received five sessions of radial extracorporeal shock wave therapy (ESWT) administered at 5-day intervals. Treatment was delivered using the Chattanooga Intelect® RPW device with 2000 pulses per session at 1.8-2.0 bar pressure and 8 Hz frequency. Stimulation was applied to the peripatellar soft tissues, including the medial and lateral patellofemoral retinaculum and the infrapatellar fat pad, while avoiding direct application over the patellar tendon. Pressure was progressively increased across sessions based on tolerance. |
| Exercise + ESWT | Experimental | Behavioral: Home-based Exercise Program, Device: Radial Extracorporeal Shock Wave Therapy (ESWT)Participants performed the same home-based strengthening program as the Exercise group (hip and knee strengthening, ≥3 sessions/week for 4 weeks). In addition, they received five sessions of radial extracorporeal shock wave therapy (2000 pulses; 1.8-2.0 bar; 8 Hz) at 5-day intervals applied to the peripatellar soft tissues while avoiding the patellar tendon. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 45 years.
- Clinical diagnosis of patellofemoral pain syndrome (PFPS) characterized by anterior or retropatellar knee pain lasting at least 8 weeks.
- Pain provoked during at least two of the following activities: running, jumping, squatting, stair climbing, or prolonged sitting.
- Worst knee pain score of ≥3 on the Visual Analog Scale (0-10).
- Ability to understand and follow the exercise program and assessment procedures.
Key exclusion criteria (8 listed)
- Evidence of intra-articular knee pathology other than grade 1-2 meniscal changes or grade 1 chondromalacia patella on MRI.
- Clinical signs of patellar instability.
- Localized tenderness indicating alternative diagnoses (e.g., patellar tendinopathy, iliotibial band syndrome, pes anserine bursitis).
- History of knee surgery on the affected side.
- Intra-articular injections (e.g., corticosteroids, hyaluronic acid, PRP) within the past 6 months.
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 |
|---|---|---|
| Home-based Exercise ProgramA structured home-based exercise program targeting hip and knee musculature. The program included warm-up, stretching, and progressive strengthening for the quadriceps, hip abductors, hip external rotators, and core stability muscles. Participants were instructed to perform the program at least three times per week for 4 weeks. Exercise progression and technique were explained individually. Adherence was monitored with weekly exercise diaries and telephone follow-up. | Behavioural | Exercise, Exercise + ESWT |
| Radial Extracorporeal Shock Wave Therapy (ESWT)Five sessions of radial extracorporeal shock wave therapy delivered at 5-day intervals using the Chattanooga Intelect® RPW device. Each session consisted of 2000 pulses at 1.8-2.0 bar pressure and 8 Hz frequency. Treatment was applied to the peripatellar soft tissues (medial and lateral retinaculum and infrapatellar fat pad), while avoiding direct application over the patellar tendon. Pressure was adjusted based on participant tolerance. | Device | ESWT, Exercise + ESWT |
Primary outcome
Visual Analogue Scale, 0-10
Time frame: Baseline, Week 1, Week 8
The Visual Analog Scale (VAS) was used to assess the worst knee pain experienced in the previous week during daily or functional activities. Participants rated their pain on a 0-10 scale, where 0 represents no pain and 10 represents the worst imaginable pain. Pain intensity was recorded at baseline prior to intervention, at one week, and at eight weeks after the treatment to evaluate short- and mid-term treatment effects.
1 secondary outcome
Kujala Patellofemoral Score
Time frame: Baseline, Week 1, Week 8
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 9 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Exercise Program and Radial Extracorporeal Shock Wave Therapy (ESWT) in people with Patellofemoral Pain Syndrome, run by Uğur Can Yalaki at 1 site in Turkey (Türkiye).
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 8 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 9 Dec 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 Turkey (Türkiye). 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?
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?
Visual Analogue Scale, 0-10 (time frame: Baseline, Week 1, Week 8). 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 9 Dec 2025.