Patellofemoral Pain SyndromeNCT06407414
Effectiveness of Neuromuscular Exercise in Patellofemoral Pain Syndrome
A study testing Exercise in people with Patellofemoral Pain Syndrome, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effects of a neuromuscular exercise program on strength, balance, sleep quality and functionality in individuals with Patellofemoral pain syndrome. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2024to 11 Sep 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study.
- Not under 30 years of age and not over 60 years of age.
- Having patellofemoral pain syndrome.
- Not having a physical disability.
- Not having undergone any knee-related surgery.
- Having access to a computer/tablet/phone and the internet.
Who cannot join
- Not accepting the voluntary consent form.
- Being under 30 years of age and over 60 years of age.
- Having undergone any knee-related surgery.
- Having cognitive, mental or psychological problems.
- Having impaired vision or hearing.
- Having a physical condition that causes significant loss of function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Neuromuscular Exercise Program on Strength, Balance, Sleep Quality and Functionality in Patellofemoral Pain Syndrome
The aim of the study is to investigate the effects of a neuromuscular exercise program on strength, balance, sleep quality and functionality in individuals with Patellofemoral pain syndrome.
Read the detailed description
The research is planned as a quantitative study. Classical knee exercises will be given to 25 individuals in the control group of the study. An exercise program consisting of Neuromuscular exercises will be applied to 25 individuals in the intervention group. In data collection, strength and balance measurements will be measured face to face by a physiotherapist, and the scales to be made through a survey will be sent to the patients online and they will be asked to fill them out. The scales and forms to be used are as follows: 1.Kujala Patellofemoral Score Scale 2.Lysholm Knee Scoring Scale 3.International Physical Activity Survey 4.Pittsburgh Sleep Quality Index 5.Y Balance Test 6.30 Seconds Sit and Stand Test Applied scales will be done by the physiotherapist. The surveys will be uploaded to the Google Forms database and the participants will be contacted via e-mail or mobile phone applications (such as Whatsapp, Telegram) to participate. They will first be asked to fill out the surveys before starting the exercise program and they will be asked to apply the exercise program. It will be explained as follows. Exercises will be planned 3 times a week and for 12 weeks. Participants will be asked to participate in the survey again after completing the exercise program.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- control, Exercise
- 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.
controlOther
classical physiotherapy methods
ExerciseOther
In addition to classical physiotherapy methods, neuromuscular exercise protocol will be applied.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | classical physiotherapy methods Receives: Other: control |
| exercise | Experimental | In addition to classical physiotherapy methods, neuromuscular exercise protocol will be applied. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala Patellofemoral Score Scale
Kujala patellofemoral scoring is a tool that allows functional evaluation of knee complaints related to the patellofemoral structure. Different scoring systems have been developed for knee-specific symptoms; however, only a few of these are focused on patellofemoral pain.The Kujala Patellofemoral Score Scale is graded on a scale of 0 to 100, with 100 being the highest possible score.
Measured: 14 weeks
Lysholm Knee Scoring Scale
The Lysholm knee scoring scale is a global assessment tool that reflects overall functional outcome and physical activity level. The Lysholm scale is an 8-item questionnaire originally designed to assess knee function after knee ligament injuries. It was later confirmed for other knee conditions. Items evaluated according to the Lysholm scale include pain, type of support, instability, locking, swelling, limping, climbing stairs, and squatting. All items are scored to yield a score of 1, ranging from 0 to 100, with a higher Lysholm score indicating a lower level of symptoms and a higher level of functioning (91-100 = excellent, 84-90 = good, 65-83 = fair).
Measured: 14 weeks
International Physical Activity Survey
Provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent(MET) -minute score. Standard metabolic equivalent (MET) values have been established for these activities.
Measured: 14 weeks
Pittsburgh Sleep Quality Index
The pittsburgh Sleep Quality Index is a quantitative measure of sleep quality to define good and bad sleep. It includes 24 questions in total. The self-assessment questions include various items related to sleep quality. The total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence of sleep disturbances or the prevalence of sleep disturbances. However, a pittsburgh Sleep Quality Index total score of five or more indicates poor sleep quality
Measured: 14 weeks
Y Balance Test
Y balance test is a simple but reliable test used to measure dynamic balance. The Y balance test is a dynamic test performed in a one-legged stance that requires strength, flexibility, core control and proprioception. It has been used to evaluate physical performance, demonstrate functional symmetry, and identify athletes at higher risk for lower extremity injury. With the test complete and all performances recorded, the test administrator can then calculate the athlete's Y Balance Test performance scores using any of, or all of, the following three equations:
Absolute reach distance (cm) = (Reach 1 + Reach 2 + Reach 3) / 3 Relative (normalised) reach distance (%) = Absolute reach distance / limb length * 100 Composite reach distance (%) = Sum of the 3 reach directions / 3 times the limb length * 100
Measured: 14 weeks
30 Second Sit and Stand Test
It is a test that evaluates the patient's sitting and standing activity, lower extremity strength and dynamic balance. The number of times the patient sits and stands within 30 seconds gives the score of the test. For this test performed to determine leg strength; A straight-backed chair with a seating height of 43.18cm (12-in) and no armrests is used. The individual is asked to sit in the middle of the chair with his back upright, his feet on the ground, and his arms crossed in front of his chest (right hand on the left shoulder, left hand on the right shoulder). While in this position, the individual starts the test with the start command and takes off as fully as he can during 30 seconds. The number of complete starts he makes during 30 seconds constitutes the subject's score.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start14 May 2024
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Büşra ARISÜT, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407414
- Sponsor's protocol ID
- Uskudar8
- Status last verified
- Sep 2024
- First submitted
- 6 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basbug P, Kilic RT, Atay AO, Bayrakci Tunay V. The effects of progressive neuromuscular exercise program and taping on muscle strength and pain in patellofemoral pain. A randomized controlled blind study. Somatosens Mot Res. 2022 Mar;39(1):39-45. doi: 10.1080/08990220.2021.1987877. Epub 2021 Oct 29.
PubMed 34713770Kim S, Roh Y, Glaviano NR, Park J. Quadriceps Neuromuscular Function During and After Exercise-Induced Fatigue in Patients With Patellofemoral Pain. J Athl Train. 2023 Jun 1;58(6):554-562. doi: 10.4085/1062-6050-0348.22.
PubMed 36395370Kolle T, Alt W, Wagner D. Effects of a 12-week home exercise therapy program on pain and neuromuscular activity in patients with patellofemoral pain syndrome. Arch Orthop Trauma Surg. 2020 Dec;140(12):1985-1992. doi: 10.1007/s00402-020-03543-y. Epub 2020 Jul 29.
PubMed 32728976Rathleff MS, Samani A, Olesen JL, Roos EM, Rasmussen S, Madeleine P. Effect of exercise therapy on neuromuscular activity and knee strength in female adolescents with patellofemoral pain-An ancillary analysis of a cluster randomized trial. Clin Biomech (Bristol). 2016 May;34:22-9. doi: 10.1016/j.clinbiomech.2016.03.002. Epub 2016 Mar 11.
PubMed 27054583Saltychev M, Dutton RA, Laimi K, Beaupre GS, Virolainen P, Fredericson M. Effectiveness of conservative treatment for patellofemoral pain syndrome: A systematic review and meta-analysis. J Rehabil Med. 2018 May 8;50(5):393-401. doi: 10.2340/16501977-2295.
PubMed 29392329
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuromuscular Exercise Program on Strength, Balance, Sleep Quality and Functionality in Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT06407414
- Acronym / sponsor ID
- Uskudar8
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 9 May 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 aim of the study is to investigate the effects of a neuromuscular exercise program on strength, balance, sleep quality and functionality in individuals with Patellofemoral pain syndrome.
Detailed description
The research is planned as a quantitative study. Classical knee exercises will be given to 25 individuals in the control group of the study. An exercise program consisting of Neuromuscular exercises will be applied to 25 individuals in the intervention group. In data collection, strength and balance measurements will be measured face to face by a physiotherapist, and the scales to be made through a survey will be sent to the patients online and they will be asked to fill them out. The scales and forms to be used are as follows: 1.Kujala Patellofemoral Score Scale 2.Lysholm Knee Scoring Scale 3.International Physical Activity Survey 4.Pittsburgh Sleep Quality Index 5.Y Balance Test 6.30 Seconds Sit and Stand Test Applied scales will be done by the physiotherapist. The surveys will be uploaded to the Google Forms database and the participants will be contacted via e-mail or mobile phone applications (such as Whatsapp, Telegram) to participate. They will first be asked to fill out the surveys before starting the exercise program and they will be asked to apply the exercise program. It will be explained as follows. Exercises will be planned 3 times a week and for 12 weeks. Participants will be asked to participate in the survey again after completing the exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: controlclassical physiotherapy methods |
| exercise | Experimental | Other: ExerciseIn addition to classical physiotherapy methods, neuromuscular exercise protocol will be applied. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Volunteering to participate in the study.
- Not under 30 years of age and not over 60 years of age.
- Having patellofemoral pain syndrome.
- Not having a physical disability.
- Not having undergone any knee-related surgery.
Key exclusion criteria (6 listed)
- Not accepting the voluntary consent form.
- Being under 30 years of age and over 60 years of age.
- Having undergone any knee-related surgery.
- Having cognitive, mental or psychological problems.
- Having impaired vision or hearing.
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 |
|---|---|---|
| controlclassical physiotherapy methods | Other | control |
| ExerciseIn addition to classical physiotherapy methods, neuromuscular exercise protocol will be applied. | Other | exercise |
Primary outcome
Kujala Patellofemoral Score Scale
Time frame: 14 weeks
Kujala patellofemoral scoring is a tool that allows functional evaluation of knee complaints related to the patellofemoral structure. Different scoring systems have been developed for knee-specific symptoms; however, only a few of these are focused on patellofemoral pain.The Kujala Patellofemoral Score Scale is graded on a scale of 0 to 100, with 100 being the highest possible score.
Lysholm Knee Scoring Scale
Time frame: 14 weeks
The Lysholm knee scoring scale is a global assessment tool that reflects overall functional outcome and physical activity level. The Lysholm scale is an 8-item questionnaire originally designed to assess knee function after knee ligament injuries. It was later confirmed for other knee conditions. Items evaluated according to the Lysholm scale include pain, type of support, instability, locking, swelling, limping, climbing stairs, and squatting. All items are scored to yield a score of 1, ranging from 0 to 100, with a higher Lysholm score indicating a lower level of symptoms and a higher level of functioning (91-100 = excellent, 84-90 = good, 65-83 = fair).
International Physical Activity Survey
Time frame: 14 weeks
Provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent(MET) -minute score. Standard metabolic equivalent (MET) values have been established for these activities.
Pittsburgh Sleep Quality Index
Time frame: 14 weeks
The pittsburgh Sleep Quality Index is a quantitative measure of sleep quality to define good and bad sleep. It includes 24 questions in total. The self-assessment questions include various items related to sleep quality. The total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence of sleep disturbances or the prevalence of sleep disturbances. However, a pittsburgh Sleep Quality Index total score of five or more indicates poor sleep quality
Y Balance Test
Time frame: 14 weeks
Y balance test is a simple but reliable test used to measure dynamic balance. The Y balance test is a dynamic test performed in a one-legged stance that requires strength, flexibility, core control and proprioception. It has been used to evaluate physical performance, demonstrate functional symmetry, and identify athletes at higher risk for lower extremity injury. With the test complete and all performances recorded, the test administrator can then calculate the athlete's Y Balance Test performance scores using any of, or all of, the following three equations: Absolute reach distance (cm) = (Reach 1 + Reach 2 + Reach 3) / 3 Relative (normalised) reach distance (%) = Absolute reach distance / limb length * 100 Composite reach distance (%) = Sum of the 3 reach directions / 3 times the limb length * 100
30 Second Sit and Stand Test
Time frame: 14 weeks
It is a test that evaluates the patient's sitting and standing activity, lower extremity strength and dynamic balance. The number of times the patient sits and stands within 30 seconds gives the score of the test. For this test performed to determine leg strength; A straight-backed chair with a seating height of 43.18cm (12-in) and no armrests is used. The individual is asked to sit in the middle of the chair with his back upright, his feet on the ground, and his arms crossed in front of his chest (right hand on the left shoulder, left hand on the right shoulder). While in this position, the individual starts the test with the start command and takes off as fully as he can during 30 seconds. The number of complete starts he makes during 30 seconds constitutes the subject's score.
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 Sep 2024.
- Background: PubMed 34713770Basbug P, Kilic RT, Atay AO, Bayrakci Tunay V. The effects of progressive neuromuscular exercise program and taping on muscle strength and pain in patellofemoral pain. A randomized controlled blind study. Somatosens Mot Res. 2022 Mar;39(1):39-45. doi: 10.1080/08990220.2021.1987877. Epub 2021 Oct 29.
- Background: PubMed 36395370Kim S, Roh Y, Glaviano NR, Park J. Quadriceps Neuromuscular Function During and After Exercise-Induced Fatigue in Patients With Patellofemoral Pain. J Athl Train. 2023 Jun 1;58(6):554-562. doi: 10.4085/1062-6050-0348.22.
- Background: PubMed 32728976Kolle T, Alt W, Wagner D. Effects of a 12-week home exercise therapy program on pain and neuromuscular activity in patients with patellofemoral pain syndrome. Arch Orthop Trauma Surg. 2020 Dec;140(12):1985-1992. doi: 10.1007/s00402-020-03543-y. Epub 2020 Jul 29.
- Background: PubMed 27054583Rathleff MS, Samani A, Olesen JL, Roos EM, Rasmussen S, Madeleine P. Effect of exercise therapy on neuromuscular activity and knee strength in female adolescents with patellofemoral pain-An ancillary analysis of a cluster randomized trial. Clin Biomech (Bristol). 2016 May;34:22-9. doi: 10.1016/j.clinbiomech.2016.03.002. Epub 2016 Mar 11.
- Background: PubMed 29392329Saltychev M, Dutton RA, Laimi K, Beaupre GS, Virolainen P, Fredericson M. Effectiveness of conservative treatment for patellofemoral pain syndrome: A systematic review and meta-analysis. J Rehabil Med. 2018 May 8;50(5):393-401. doi: 10.2340/16501977-2295.
- 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.
Büşra ARISÜT study chair
Uskudar 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 Exercise in people with Patellofemoral Pain Syndrome, run by Uskudar 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 6 inclusion and 6 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 Sep 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?
Kujala Patellofemoral Score Scale (time frame: 14 weeks). The study lists 6 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 NCT06407414, which also lists 5 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 19 Sep 2024.