Patellofemoral PainNCT05811637
Investigation of the Effect of Pilates Exercises on Patellofemoral Pain
A study testing Pilates Exercise and Supervised Rehabilitation in people with Patellofemoral Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effectiveness of Pilates exercises in Patellofemoral pain patients compared to hip and knee combined exercises in improving pain, muscle strength, flexibility, function and quality of life in short term. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patellofemoral Pain
- What is being tested?
- Pilates Exercise and Supervised Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 15 Nov 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having characteristic signs of PFP (retropatellar or peripatellar pain)
- Presence of at least 3 points of retropatellar or peripatellar pain on the Numbered Pain Rating Scale (NPRS) with squatting, climbing stairs, prolonged sitting, or functional activity that burdens the PFP
- Presence of any of the criteria such as tenderness, small effusion in the patellar facet palpation
Who cannot join
- Patellofemoral dislocation, subluxation, intra-articular knee pathology
- Previous lower extremity surgery, and knee-related trauma
- A history of hip pathology or neurological disorders
- Knee trauma in the last 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
This study aimed to investigate the effectiveness of Pilates exercises in Patellofemoral pain patients compared to hip and knee combined exercises in improving pain, muscle strength, flexibility, function and quality of life in short term.
Read the detailed description
Patellofemoral pain is a common condition characterized by pain in anterior knee, around the kneecap. It is known that exercise is beneficial in rehabilitation in general. Exercise programs applied to patients with PFP should include hip and knee-targeted combined exercises. Nowadays, Pilates is used as an effective rehabilitation tool for individuals with musculoskeletal problems, especially in reducing pain and improving function. Therefore, we believe that Pilates exercises can be effective in PFP Considering that PFP is a chronic condition and exercise therapy is one of the main strategies in the treatment. Pilates may be preferred as one of the alternative treatment method.
This randomized controlled study was designed to compare the effects of two different treatment protocols, Group-I (Supervised Rehabilitation) and Group-II (Pilates Exercises). Patients who applied to the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, Sports Medicine outpatient clinic and were diagnosed with PFP by a specialist physician based on the patient histories, physical examinations, and diagnostic imaging. The estimated desired sample size was at least 14 participants per group. We anticipated a dropout rate of 20%. Therefore, 34 participants were required for each group (Supervised Rehabilitation n=17, Pilates Exercises n=17) of both sexes, ages ranging from 18-45 years. A computer generated randomization list was used to divide the patients into two groups (https://www.randomizer.org/). An 'Informed Consent Form' was obtained from patients by explaining the purpose of the study, the duration of the study, the treatments to be applied, and possible side effects.
- Conditions
- Patellofemoral Pain
- Being tested
- Pilates Exercise, Supervised Rehabilitation
- Keywords
- Patellofemoral pain, core, quality of life, exercise, strength, pilates
- Medical subject headings
- Patellofemoral Pain Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExerciseOther
The program will be applied with the Pilates exercises every week. All patients were evaluated before and after the treatment (6 weeks).
Supervised RehabilitationOther
The program will be applied with the progression of the supervised rehabilitation in the 4th week
| Study group | Role | What they receive |
|---|---|---|
| Supervised Rehabilitation | Active comparator | The supervised rehabilitation focused mainly on strengthening the hip-knee muscles and flexibility exercises for the gastrocnemius and hamstring muscles. Hip and knee targeted strengthening and stretching exercises will be applied for 6 weeks, two sessions a week 12 sessions of all exercises, 3 sets, and 10-15 repetitions of each set. Receives: Other: Supervised Rehabilitation |
| Pilates Exercise | Active comparator | The principles of Pilates exercises will be taught to the patients in the first session, and the evaluation will be made. The exercises, including basic training exercises in the first week, will be performed for 6 weeks, each session lasting 45 minutes, two days a week, each exercise for 8-12 repetitions. The Pilates exercises, consisting of gradually increasing strengthening will be applied under the supervision of a physiotherapist. Receives: Other: Pilates Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional assessment
Kujala Anterior Knee Pain Scale is used to assess the functional disability levels of the patients.
Measured: 6 weeks
Pain assessment
The numerical NPRS is used to measure and monitor the severity of pain. The patients will be asked to rate the severity of the current pain level between 0 and 10 (0 being "no pain" and 10 being the "worst imaginable pain").
Measured: 6 weeks
Secondary outcomes (3)
Muscle strength assessment
Quadriceps strength will be measured using the Lafayette Manual Muscle Tester (Lafayette Instrument-model 01165, USA) handheld dynamometer.
Measured: 6 weeks
Muscle flexibility assessment
The flexibility of the hamstring muscles' length will be measured with the "Sit and Reach Test".
Measured: 6 weeks
Quality of life assessment
The short form SF-36v2 will be used to assess the quality of life. The scale, designed to assess the quality of life, covers physical, social, and psychological conditions.
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 posted13 Apr 2023
- Study start15 Apr 2023
- Primary completion15 Oct 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral PainStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Model description
- Randomized and trial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Celik, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811637
- Sponsor's protocol ID
- D2023
- Status last verified
- Nov 2024
- First submitted
- 31 Mar 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
- ClinicalTrials.gov ID
- NCT05811637
- Acronym / sponsor ID
- D2023
- Conditions
- Patellofemoral Pain
- Keywords
- Patellofemoral pain, core, quality of life, exercise, strength, pilates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 13 Apr 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.
This study aimed to investigate the effectiveness of Pilates exercises in Patellofemoral pain patients compared to hip and knee combined exercises in improving pain, muscle strength, flexibility, function and quality of life in short term.
Detailed description
Patellofemoral pain is a common condition characterized by pain in anterior knee, around the kneecap. It is known that exercise is beneficial in rehabilitation in general. Exercise programs applied to patients with PFP should include hip and knee-targeted combined exercises. Nowadays, Pilates is used as an effective rehabilitation tool for individuals with musculoskeletal problems, especially in reducing pain and improving function. Therefore, we believe that Pilates exercises can be effective in PFP Considering that PFP is a chronic condition and exercise therapy is one of the main strategies in the treatment. Pilates may be preferred as one of the alternative treatment method.
This randomized controlled study was designed to compare the effects of two different treatment protocols, Group-I (Supervised Rehabilitation) and Group-II (Pilates Exercises). Patients who applied to the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, Sports Medicine outpatient clinic and were diagnosed with PFP by a specialist physician based on the patient histories, physical examinations, and diagnostic imaging. The estimated desired sample size was at least 14 participants per group. We anticipated a dropout rate of 20%. Therefore, 34 participants were required for each group (Supervised Rehabilitation n=17, Pilates Exercises n=17) of both sexes, ages ranging from 18-45 years. A computer generated randomization list was used to divide the patients into two groups (https://www.randomizer.org/). An 'Informed Consent Form' was obtained from patients by explaining the purpose of the study, the duration of the study, the treatments to be applied, and possible side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized and trial
| Arm | Type | Receives |
|---|---|---|
| Supervised Rehabilitation | Active comparator | Other: Supervised RehabilitationThe supervised rehabilitation focused mainly on strengthening the hip-knee muscles and flexibility exercises for the gastrocnemius and hamstring muscles. Hip and knee targeted strengthening and stretching exercises will be applied for 6 weeks, two sessions a week 12 sessions of all exercises, 3 sets, and 10-15 repetitions of each set. |
| Pilates Exercise | Active comparator | Other: Pilates ExerciseThe principles of Pilates exercises will be taught to the patients in the first session, and the evaluation will be made. The exercises, including basic training exercises in the first week, will be performed for 6 weeks, each session lasting 45 minutes, two days a week, each exercise for 8-12 repetitions. The Pilates exercises, consisting of gradually increasing strengthening will be applied under the supervision of a physiotherapist. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having characteristic signs of PFP (retropatellar or peripatellar pain)
- Presence of at least 3 points of retropatellar or peripatellar pain on the Numbered Pain Rating Scale (NPRS) with squatting, climbing stairs, prolonged sitting, or functional activity that burdens the PFP
- Presence of any of the criteria such as tenderness, small effusion in the patellar facet palpation
Key exclusion criteria (4 listed)
- Patellofemoral dislocation, subluxation, intra-articular knee pathology
- Previous lower extremity surgery, and knee-related trauma
- A history of hip pathology or neurological disorders
- Knee trauma in the last 1 month
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 |
|---|---|---|
| Pilates ExerciseThe program will be applied with the Pilates exercises every week. All patients were evaluated before and after the treatment (6 weeks). | Other | Pilates Exercise |
| Supervised RehabilitationThe program will be applied with the progression of the supervised rehabilitation in the 4th week | Other | Supervised Rehabilitation |
Primary outcome
Functional assessment
Time frame: 6 weeks
Kujala Anterior Knee Pain Scale is used to assess the functional disability levels of the patients.
Pain assessment
Time frame: 6 weeks
The numerical NPRS is used to measure and monitor the severity of pain. The patients will be asked to rate the severity of the current pain level between 0 and 10 (0 being "no pain" and 10 being the "worst imaginable pain").
3 secondary outcomes
Muscle strength assessment
Time frame: 6 weeks
Muscle flexibility assessment
Time frame: 6 weeks
Quality of life assessment
Time frame: 6 weeks
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 19 Nov 2024.
- 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.
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 Pilates Exercise and Supervised Rehabilitation in people with Patellofemoral Pain, run by Istanbul University 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 3 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: finished, as of the sponsor's last update on 19 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 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?
Functional assessment (time frame: 6 weeks). The study lists 2 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 19 Nov 2024.