Patellofemoral Pain SyndromeNCT05351814
Effectiveness Of Core Stabilization Exercises In Patellofemoral Pain Syndrome
A study testing Exercise in people with Patellofemoral Pain Syndrome, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled study; To investigate the multifactorial effectiveness of core stabilization exercises applied in patients diagnosed with patellofemoral pain syndrome. Read more about this study
- Who is it for?
- Ages 20 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
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2022to 20 Jun 2022
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20/60 years old/with
- Occur during at least two activities of prolonged sitting, climbing stairs or inclines, squatting, running and jumping
- Retropatellar pain persisting for at least one month
- persons diagnosed with patellofemoral pain syndrome by the doctor are included in the study.
Who cannot join
- Meniscus and ligament lesions
- Osteoarthritis
- patellofemoral dislocation and/or subluxation history
- Osseous anomalies and history of knee surgery
- Pregnancy status
- Patients using analgesics and anti-inflammatory drugs will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Core Stabilization Exercises In Patellofemoral Pain Syndrome
The aim of this randomized controlled study; To investigate the multifactorial effectiveness of core stabilization exercises applied in patients diagnosed with patellofemoral pain syndrome.
20/60 years old/with retropatellar pain that occurs during at least two of the activities and persists for at least one month While patients diagnosed with patellofemoral pain syndrome (PFPS) were included in the study; Patients with meniscus and ligament lesions, osteoarthritis, patellofemoral dislocation and/or subluxation history, osseous anomalies and history of knee surgery, pregnancy status, and patients using analgesics and anti-inflammatory drugs will not be included in the study.
Read more
Individuals will be divided into two groups by computerized randomization. Control group; Traditional patellofemoral pain syndrome exercises, (n=20) Core stability group; Core stabilization and hip exercises will be given in addition to traditional patellofemoral pain syndrome exercises. (n=20) After obtaining the demographic information of the cases, before and after the treatment; Visual analog scale (VAS) change, Kuala scale change, Trunk forward flexion flexibility change, Hamstring muscle flexibility change, Sit-reach test change, Q angle measurement change, Normal joint movement change, McGill stabilization tests change, Timed get up and go test change, Single leg jump test change, Y balance test change, Muscle strength change will be evaluated by the same person using the Corbin Posture analysis change and Foot posture index (FPI) change parameters.
IMPLEMENTATION PROTOCOL
- Control group; traditional patellofemoral pain syndrome exercises; isometric exercises 3 sets of 10 repetitions in one session, balance exercise 30/45 sec, one leg balance exercise 45/60 sec , stretching exercises 4 sets 5 repetitions 20 sec duration, off kinetic chain (CHC) AND open kinetic chain (ACZ) exercises were planned as 3 sets for 4 weeks and 3 days a week .
- Core stability group; In addition to traditional patellofemoral pain syndrome exercises; hip muscle strengthening exercises are 3 sets of 10 repetitions in each session, and (core) stabilization exercises are 1st and 2nd weeks 2 sets 15 repetitions 3rd and 4th weeks 2 sets 5 repetition was planned for 4 weeks and 3 days a week.
While the patients will be exercised with a physiotherapist 1 day a week, the treatment will be followed as a home exercise program 2 days a week.
Read the detailed description
SUBJECT AND OBJECTIVE OF THE RESEARCH The term patellofemoral pain syndrome (PFPS) is defined as retropatellar or peripatellar pain that occurs as a result of physical and biomechanical changes that causes pain in the anterior part of the knee related to changes in the patellofemoral joint.
Patellofemoral pain is one of the most common musculoskeletal problems, accounting for approximately 9-10% of all musculoskeletal complaints and 20-40% of all knee problems. PFPS is frequently encountered among young, physically active individuals. It is a common knee problem. It occurs most frequently in women, athletes and soldiers.
Many factors such as decrease in quadriceps femoris strength, decreased flexibility, activity mismatch between vastus medialis obliqua and vastus lateralis obliqua muscles, rotations between femur and tibia, excessive subtalar pronation, positional changes in the kneecap have been associated with patellofemoral pain syndrome. In a systematic analysis, it was observed that patients with PFPS had a decrease in the abduction/external rotation/extension strength of the affected side when compared to healthy individuals.
In a guideline regarding foot problems; It has been reported that foot pronation causes internal rotation of the tibia or femur (femoral anteversion), which disrupts the patellofemoral mechanism, while the pessary sergeant places more stress on the patellofemoral mechanism, especially when a person is running, since less softening and a harder contact are provided for the leg when the foot hits the ground.
In a controlled study involving patients with chronic PFPS, it was found that there was no significant difference between arthroscopy and home exercise program compared to home exercise alone, and home exercise alone was very effective.
The target in PFPS rehabilitation; to restore the functions of the joint and relieve pain. The first step in traditional rehabilitation is to strengthen the Quadriceps femoris (QF) and Vastus medialis obliqua (VMO) muscles. The treatment program consists of Open kinetic chain/Closed kinetic chain (ACZ/CHZ), stretching (iliotibial band, QF, hamstring, gastrocnemius, gastrocsoleus) exercises.
It was concluded that isokinetic exercises prevent extensor strength loss in patellofemoral pain syndrome, but they are not sufficient alone. In another study, it was found that hip strengthening exercises in addition to knee strengthening exercises were more effective in both improving function and reducing pain in sedentary women with PFPS than the group performing knee strengthening exercises alone. it was observed that the pain decreased more in the group in which both closed kinetic chain exercises and hip strengthening exercises were given compared to the group given only closed kinetic chain exercises.
In a randomized controlled study, core neuromuscular training was given in addition to routine physical therapy, and it was observed that patients improved more than routine physical therapy. In another study, core muscle strengthening exercises were given in addition to routine physical therapy and it was observed that it improved both pain and dynamic balance in patients compared to routine physical therapy alone.
Weight-bearing exercises are more functional than non-weight-bearing exercises because they require multi-joint movement, facilitate a functional muscle recruitment pattern, and stimulate proprioceptors. Because of these advantages, clinicians often recommend weight-bearing exercises in the rehabilitation of PFPS patients.
One systematic analysis determined the efficacy of physical exercise as a conservative treatment for patellofemoral pain syndrome by looking at the results of ten moderate to high quality clinical studies and showed that the most effective patellofemoral pain syndrome management included strengthening exercises for the hip at baseline. Due to their role in knee biomechanics, the addition of stretching exercises for the external rotator and abductor muscles, core muscles and proprioceptive, neuromuscular exercises " reduces pain in patellofemoral pain syndrome".
In the light of all these studies, when the literature was examined, very few studies were found that examined the effect of core stabilization exercises in individuals with patellofemoral pain syndrome, and these studies were only studied on certain parameters on women. The aim of this randomized controlled study; To investigate the multifactorial effectiveness of core stabilization exercises applied in patients diagnosed with patellofemoral pain syndrome.
Research Questions and Hypotheses:
What are the effects of core stabilization exercises in patellofemoral pain syndrome? H0: Core stabilization exercises are not effective on pain, functional level, balance, flexibility, muscle strength, normal joint movement, posture in patellofemoral pain syndrome.
H1: effective. Core stabilization exercises are effective on pain, functional level, balance, flexibility, muscle strength, normal joint movement and posture in patellofemoral pain syndrome.
Material and Method:
The study was planned as a randomized controlled trial. The number of volunteers to take part in the study was determined using the G-Power program. In the study, the randomized controlled study of 'Foroughi et al.' 45 named "Effects of Isolated Core Postural Control Training on Knee Pain and Function in Women with Patellofemoral Pain Syndrome: α=0.05, power 80% and effect size 0.3 were taken as an example. As a result of the calculations, it was found that there should be a total of 18 people, 9 people in each group. However, for a good statistical calculation or for the loss of cases, it was decided to take twice the result of this calculation. A total of 40 people, 20 people in each group, will be included in the study.
20/60 years old/with retropatellar pain that occurs during at least two of the activities and persists for at least one month While patients diagnosed with PFPS were included in the study; Patients with meniscus and ligament lesions , osteoarthritis , patellofemoral dislocation and/or subluxation history, osseous anomalies and history of knee surgery , pregnancy status, and patients using analgesics and anti-inflammatory drugs will not be included in the study.
Individuals will be divided into two groups by computerized randomization. Control group; Traditional patellofemoral pain syndrome exercises, (n=20) Core stability group; Core stabilization and hip exercises will be given in addition to traditional patellofemoral pain syndrome exercises. (n=20) After obtaining the demographic information of the cases change, before and after the treatment; Visual analog scale (VAS) change, Kuala scale change, Trunk forward flexion flexibility change, Hamstring muscle flexibility change, Sit-reach test change, Q angle measurement change, Normal joint movement change, McGill stabilization tests change, Timed get up and go test change, Single leg jump test change, Y balance test change, Muscle strength change will be evaluated by the same person using the Corbin Posture analysis change and Foot posture index (FPI) change parameters.
IMPLEMENTATION PROTOCOL
- Control group; traditional patellofemoral pain syndrome exercises; isometric exercises 3 sets of 10 repetitions in one session, balance exercise 30/45 sec, one leg balance exercise 45/60 sec , stretching exercises 4 sets 5 repetitions 20 sec duration, off kinetic chain (CHC) AND open kinetic chain (ACZ) exercises were planned as 3 sets for 4 weeks and 3 days a week .
- Core stability group; In addition to traditional patellofemoral pain syndrome exercises; hip muscle strengthening exercises are 3 sets of 10 repetitions in each session, and (core) stabilization exercises are 1st and 2nd weeks 2 sets 15 repetitions 3rd and 4th weeks 2 sets 5 repetition was planned for 4 weeks and 3 days a week.
While the patients will be exercised with a physiotherapist 1 day a week, the treatment will be followed as a home exercise program 2 days a week.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Exercise
- Keywords
- Core Stability, Patellofemoral Pain, Exercise Therapy, Core Balance, Flexibility
- 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.
ExerciseOther
While the patients will be exercised with a physiotherapist 1 day a week, the treatment will be followed as a home exercise program 2 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Control group; traditional patellofemoral pain syndrome exercises; isometric exercises 3 sets of 10 repetitions in one session, balance exercise 30/45 sec, one leg balance exercise 45/60 sec , stretching exercises 4 sets 5 repetitions 20 sec duration, off kinetic chain (CHC) AND open kinetic chain (ACZ) exercises were planned as 3 sets for 4 weeks and 3 days a week. Receives: Other: Exercise |
| Core Stability group | Experimental | Core stability group; In addition to traditional patellofemoral pain syndrome exercises; hip muscle strengthening exercises are 3 sets of 10 repetitions in each session, and (core) stabilization exercises are 1st and 2nd weeks 2 sets 15 repetitions 3rd and 4th weeks 2 sets 5 repetition was planned for 4 weeks and 3 days a week. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic information form change
The patient's age, height, weight and disease history are questioned.
Measured: At baseline
The visual analogue scale(VAS) change
was described in a psychology journal in 1921. It is a visual scale, not a verbal one. This 11-point scale (from 0 to 10) has different names, but the verbal rating scale (VAS) is most often used. The VAS scoring has a 10 cm long straight line on which the patient can mark the degree of discomfort. For example, when measuring pain, you might have "no pain" on the left end of the line and "worst pain imaginable" on the right, or the like. The result can be read in millimeters (0 - 100 mm), or whole and half a centimeter (0 - 10 cm).
Measured: Change from baseline the visual analogue scale at 4 weeks
Kuala scale change
Kuala et al. He developed it in 1993 to assess subjective symptoms and functional limitations in PFPS. The score consists of 13 questions. These questions address activity-related pain when climbing stairs, squatting, running, jumping, performing weight-bearing activities, and sitting for long periods of time with the knee flexed. He also questions symptoms such as limping, swelling, patella subluxation, quadriceps muscle atrophy, lack of flexion, and flexion pain. The total score ranges from 0 to 100. A higher score indicates fewer complaints.
Measured: Change from baseline kuala scale at 4 weeks
Y balance test change
The Y Balance test (YBT) is the most common dynamic balance assessment used in clinical practice and research to evaluate dynamic balance in 3 directions of reach YBT measures dynamic balance during single leg stance and requires strength, proprioception, and flexibility. YBT is a contralateral leg reaching system in one-leg stance anterior (ANT), posterolateral (PL), and posteromedial (PM) directions. A composite score is then calculated by summing the distance reached in 3 directions of reach (ANT, PL, and PM) relative to leg length. It has been reported that YBT predicts injury based on overall access performance (different threshold points depending on the sample) and asymmetry between the limbs (anterior access difference greater than 4 cm). In a study, YBT revealed inter-interpretive test-retest reliability and minimal measurement error.
Measured: Change from baseline Y balance test at 4 weeks
Body front flexibility assessment change
In this test, the person stands on a 15 cm high block and leans forward without bending the knees and tries to touch the fingertip. The test evaluates the flexibility of the lumbar region, hamstring muscles and M. gastrocnemius. The distance between the fingertip and the wooden block surface is measured with a tape measure, and the values that pass the block surface are recorded in cm as positive, and the values below the block surface as negative.
Measured: Change from baseline Body front flexibility assessment at 4 weeks
Muscle strength change
Manual muscle testing does not consistently detect muscle strength deficiencies or clearly demonstrate the impact of such deficiencies on the knee. For this reason, functional performance testing may be preferred. Functional performance tests are a test for the knee and the entire lower extremity. 'Loudon et al.' He evaluated five different functional performance tests (anteromedial lunge, step-down, single-leg press, bilateral squat, balance reaching) in individuals with patellofemoral pain. All five of these tests revealed high reliability and correlated with changes in pain scales. Among these tests as muscle strength assessment in cases; anteromedial lunge, step down (step), balance reaching test will be used.
If the patient cannot stabilize the pelvis by standing (on one leg) for 1 minute on the affected leg (the other side pelvis falls), it was decided to perform it on our patients, based on the study, which is said to be a sign of weakness of the hip muscles.
Measured: Change from baseline Muscle strength at 4 weeks
Normal joint movement change
Measurement will be made with G-Pro, an Android application. The G-Pro app is a highly accurate reliable tool for measuring knee flexion angle. Its results were found to be more significant and more accurate than the results of conventional instruments . It is preferred because it is easy to apply and has high reliability.
Measured: Change from baseline Normal joint movement at 4 weeks
Corbin posture analyses change
Posture analyses will be performed to determine the changes in the posture of the individuals included in the study. These changes will be scored using the form prepared by Corbin et al. that includes lateral and posterior observations. This form is based on detecting postural disorders by observation made from the two planes mentioned and scoring them according to their severity. The scores will be added last and the postural status will be classified according to the total score. Postural anomalies were scored (0: none, 1: mild, 2: moderate, 3: severe). Postural scores obtained by looking from the lateral and posterior aspects are summed (0-2: excellent, 3-4: very good, 5-7: good, 8-11: moderate, 12≥ bad).
Measured: Change from baseline Corbin posture analyses at 4 weeks
Foot Posture index or (FPI) change
A six-item assessment scale (Foot Posture index or FPI) was developed in response to the need for a fast, easy and reliable method to measure foot position. The FPI consists of observing the bottom of the hind and forefoot of an individual standing in a relaxed position. The hindfoot is assessed by palpation of the talus head, observing the curves above and below the lateral malleoli, and inversion/eversion of the calcaneus. The forefoot consists of assessing the extent of abduction/adduction of the forefoot in the hindfoot, while checking the swelling in the talo-navicular joint area and the alignment of the medial longitudinal arch.
Measured: Change from baseline Foot posture index at 4 weeks
Assessment of hamstring muscle flexibility change
In the supine position, the hip and knee are fixed in 90 degree flexion. The pivot point of the goniometer is placed on the lateral condyle of the femur. The knee angle will be measured by extending the patient's knee with the fixed arm parallel to the lateral midline of the femur and the mobile arm following the fibula. By subtracting the angular value found from 90 degrees, the shortness value will be obtained.
Measured: Change from baseline Assessment of hamstring muscle flexibility at 4 weeks
Sit and reach test change
It was used for flexibility assessment. The patients will be asked to sit on the stretcher, with their legs extended and without shoes, and lean the soles of their feet on the front table. Then, the patient is asked to lie forward on the stretcher as much as possible, without flexing his knees, from his torso (waist and hip), and the extreme point where his fingers reach is cm. The best result will be recorded by measuring in terms of and repeating this test 3 times.
Measured: Change from baseline Sıt and reach test at 4 weeks
Q angle measurement change
It will be measured with a goniometer in the supine position, with the hip and knee extended. Between the line drawn from the spina iliaca anterior superior (SiAS) to the middle of the patella and the line drawn from the middle of the patella between the tuberositas tibia, this lateral angle will be measured 3 times and recorded. The average of the measurements will be recorded.
Measured: Change from baseline Q angle measurement at 4 weeks
Mcgill stabilization tests change
Endurance tests known as McGill protocol; It was originally developed to evaluate core stabilization in patients with low back pain. This protocol consists of different endurance tests: lateral endurance, trunk flexor endurance, and trunk extensor endurance. In these tests, the time in seconds that the isometric posture is maintained is measured and recorded.
Measured: Change from baseline Mcgill stabilization tests at 4 weeks
Timed start and go test change
The patients will be asked to start from a sitting position in a chair, get up with the given command, walk the predetermined distance of 3 meters as fast as they can, and return to their places. The time from the time they get up from the chair and sit down again will be recorded with the stopwatch. The measurements will be repeated 3 times and the average will be recorded in seconds.
Measured: Change from baseline Timed start and go test at 4 weeks
Single leg jump test change
The patients begin the test in a position with their hands on their waists on one leg. Patients are asked to jump as far as possible in a parallel plane and land with the same leg. In the tape measure fixed to the ground, the distance between the patient's jump and the starting point is recorded in cm.
Measured: Change from baseline Single leg jump test at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start14 Mar 2022
- Primary completion20 May 2022 (estimated)
- Study completion20 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Individuals will be divided into two groups by computerized randomization. Control group; Traditional patellofemoral pain syndrome exercises, (n=20) Core stability group; Core stabilization and hip exercises will be given in addition to traditional patellofemoral pain syndrome exercises. (n=20)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Demirtaş, Istinye University
- Investigators
- Berrak VARHAN, Assoc. Prof., Study director, Ethics committee protocol number 21-128
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351814
- Sponsor's protocol ID
- 21-128
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nunes GS, Stapait EL, Kirsten MH, de Noronha M, Santos GM. Clinical test for diagnosis of patellofemoral pain syndrome: Systematic review with meta-analysis. Phys Ther Sport. 2013 Feb;14(1):54-9. doi: 10.1016/j.ptsp.2012.11.003. Epub 2012 Dec 8.
PubMed 23232069Prins MR, van der Wurff P. Females with patellofemoral pain syndrome have weak hip muscles: a systematic review. Aust J Physiother. 2009;55(1):9-15. doi: 10.1016/s0004-9514(09)70055-8.
PubMed 19226237Tyler TF, Nicholas SJ, Mullaney MJ, McHugh MP. The role of hip muscle function in the treatment of patellofemoral pain syndrome. Am J Sports Med. 2006 Apr;34(4):630-6. doi: 10.1177/0363546505281808. Epub 2005 Dec 19.
PubMed 16365375Fredericson M, Yoon K. Physical examination and patellofemoral pain syndrome. Am J Phys Med Rehabil. 2006 Mar;85(3):234-43. doi: 10.1097/01.phm.0000200390.67408.f0.
PubMed 16505640Magalhaes E, Fukuda TY, Sacramento SN, Forgas A, Cohen M, Abdalla RJ. A comparison of hip strength between sedentary females with and without patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2010 Oct;40(10):641-7. doi: 10.2519/jospt.2010.3120.
PubMed 20508327Besier TF, Fredericson M, Gold GE, Beaupre GS, Delp SL. Knee muscle forces during walking and running in patellofemoral pain patients and pain-free controls. J Biomech. 2009 May 11;42(7):898-905. doi: 10.1016/j.jbiomech.2009.01.032. Epub 2009 Mar 6.
PubMed 19268945Steinberg N, Siev-Ner I, Peleg S, Dar G, Masharawi Y, Zeev A, Hershkovitz I. Joint range of motion and patellofemoral pain in dancers. Int J Sports Med. 2012 Jul;33(7):561-6. doi: 10.1055/s-0031-1301330. Epub 2012 May 4.
PubMed 22562733Tsuji T, Matsuyama Y, Goto M, Yimin Y, Sato K, Hasegawa Y, Ishiguro N. Knee-spine syndrome: correlation between sacral inclination and patellofemoral joint pain. J Orthop Sci. 2002;7(5):519-23. doi: 10.1007/s007760200092.
PubMed 12355123Juhn MS. Patellofemoral pain syndrome: a review and guidelines for treatment. Am Fam Physician. 1999 Nov 1;60(7):2012-22.
PubMed 10569504Noehren B, Hamill J, Davis I. Prospective evidence for a hip etiology in patellofemoral pain. Med Sci Sports Exerc. 2013 Jun;45(6):1120-4. doi: 10.1249/MSS.0b013e31828249d2.
PubMed 23274607Kettunen JA, Harilainen A, Sandelin J, Schlenzka D, Hietaniemi K, Seitsalo S, Malmivaara A, Kujala UM. Knee arthroscopy and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomized controlled trial. BMC Med. 2007 Dec 13;5:38. doi: 10.1186/1741-7015-5-38.
PubMed 18078506Clijsen R, Fuchs J, Taeymans J. Effectiveness of exercise therapy in treatment of patients with patellofemoral pain syndrome: systematic review and meta-analysis. Phys Ther. 2014 Dec;94(12):1697-708. doi: 10.2522/ptj.20130310. Epub 2014 Jul 31.
PubMed 25082920Alaca R, Yilmaz B, Goktepe AS, Mohur H, Kalyon TA. Efficacy of isokinetic exercise on functional capacity and pain in patellofemoral pain syndrome. Am J Phys Med Rehabil. 2002 Nov;81(11):807-13. doi: 10.1097/00002060-200211000-00002.
PubMed 12394991Fukuda TY, Rossetto FM, Magalhaes E, Bryk FF, Lucareli PR, de Almeida Aparecida Carvalho N. Short-term effects of hip abductors and lateral rotators strengthening in females with patellofemoral pain syndrome: a randomized controlled clinical trial. J Orthop Sports Phys Ther. 2010 Nov;40(11):736-42. doi: 10.2519/jospt.2010.3246.
PubMed 21041965Ismail MM, Gamaleldein MH, Hassa KA. Closed kinetic chain exercises with or without additional hip strengthening exercises in management of patellofemoral pain syndrome: a randomized controlled trial. Eur J Phys Rehabil Med. 2013 Oct;49(5):687-98. Epub 2013 Jul 2.
PubMed 23820880
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Core Stabilization Exercises In Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT05351814
- Acronym / sponsor ID
- 21-128
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Core Stability, Patellofemoral Pain, Exercise Therapy, Core Balance, Flexibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 28 Apr 2022 (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 this randomized controlled study; To investigate the multifactorial effectiveness of core stabilization exercises applied in patients diagnosed with patellofemoral pain syndrome.
20/60 years old/with retropatellar pain that occurs during at least two of the activities and persists for at least one month While patients diagnosed with patellofemoral pain syndrome (PFPS) were included in the study; Patients with meniscus and ligament lesions, osteoarthritis, patellofemoral dislocation and/or subluxation history, osseous anomalies and history of knee surgery, pregnancy status, and patients using analgesics and anti-inflammatory drugs will not be included in the study.
Individuals will be divided into two groups by computerized randomization. Control group; Traditional patellofemoral pain syndrome exercises, (n=20) Core stability group; Core stabilization and hip exercises will be given in addition to traditional patellofemoral pain syndrome exercises. (n=20) After obtaining the demographic information of the cases, before and after the treatment; Visual analog scale (VAS) change, Kuala scale change, Trunk forward flexion flexibility change, Hamstring muscle flexibility change, Sit-reach test change, Q angle measurement change, Normal joint movement change, McGill stabilization tests change, Timed get up and go test change, Single leg jump test change, Y balance test change, Muscle strength change will be evaluated by the same person using the Corbin Posture analysis change and Foot posture index (FPI) change parameters.
IMPLEMENTATION PROTOCOL
- Control group; traditional patellofemoral pain syndrome exercises; isometric exercises 3 sets of 10 repetitions in one session, balance exercise 30/45 sec, one leg balance exercise 45/60 sec , stretching exercises 4 sets 5 repetitions 20 sec duration, off kinetic chain (CHC) AND open kinetic chain (ACZ) exercises were planned as 3 sets for 4 weeks and 3 days a week .
- Core stability group; In addition to traditional patellofemoral pain syndrome exercises; hip muscle strengthening exercises are 3 sets of 10 repetitions in each session, and (core) stabilization exercises are 1st and 2nd weeks 2 sets 15 repetitions 3rd and 4th weeks 2 sets 5 repetition was planned for 4 weeks and 3 days a week.
While the patients will be exercised with a physiotherapist 1 day a week, the treatment will be followed as a home exercise program 2 days a week.
Detailed description
SUBJECT AND OBJECTIVE OF THE RESEARCH The term patellofemoral pain syndrome (PFPS) is defined as retropatellar or peripatellar pain that occurs as a result of physical and biomechanical changes that causes pain in the anterior part of the knee related to changes in the patellofemoral joint.
Patellofemoral pain is one of the most common musculoskeletal problems, accounting for approximately 9-10% of all musculoskeletal complaints and 20-40% of all knee problems. PFPS is frequently encountered among young, physically active individuals. It is a common knee problem. It occurs most frequently in women, athletes and soldiers.
Many factors such as decrease in quadriceps femoris strength, decreased flexibility, activity mismatch between vastus medialis obliqua and vastus lateralis obliqua muscles, rotations between femur and tibia, excessive subtalar pronation, positional changes in the kneecap have been associated with patellofemoral pain syndrome. In a systematic analysis, it was observed that patients with PFPS had a decrease in the abduction/external rotation/extension strength of the affected side when compared to healthy individuals.
In a guideline regarding foot problems; It has been reported that foot pronation causes internal rotation of the tibia or femur (femoral anteversion), which disrupts the patellofemoral mechanism, while the pessary sergeant places more stress on the patellofemoral mechanism, especially when a person is running, since less softening and a harder contact are provided for the leg when the foot hits the ground.
In a controlled study involving patients with chronic PFPS, it was found that there was no significant difference between arthroscopy and home exercise program compared to home exercise alone, and home exercise alone was very effective.
The target in PFPS rehabilitation; to restore the functions of the joint and relieve pain. The first step in traditional rehabilitation is to strengthen the Quadriceps femoris (QF) and Vastus medialis obliqua (VMO) muscles. The treatment program consists of Open kinetic chain/Closed kinetic chain (ACZ/CHZ), stretching (iliotibial band, QF, hamstring, gastrocnemius, gastrocsoleus) exercises.
It was concluded that isokinetic exercises prevent extensor strength loss in patellofemoral pain syndrome, but they are not sufficient alone. In another study, it was found that hip strengthening exercises in addition to knee strengthening exercises were more effective in both improving function and reducing pain in sedentary women with PFPS than the group performing knee strengthening exercises alone. it was observed that the pain decreased more in the group in which both closed kinetic chain exercises and hip strengthening exercises were given compared to the group given only closed kinetic chain exercises.
In a randomized controlled study, core neuromuscular training was given in addition to routine physical therapy, and it was observed that patients improved more than routine physical therapy. In another study, core muscle strengthening exercises were given in addition to routine physical therapy and it was observed that it improved both pain and dynamic balance in patients compared to routine physical therapy alone.
Weight-bearing exercises are more functional than non-weight-bearing exercises because they require multi-joint movement, facilitate a functional muscle recruitment pattern, and stimulate proprioceptors. Because of these advantages, clinicians often recommend weight-bearing exercises in the rehabilitation of PFPS patients.
One systematic analysis determined the efficacy of physical exercise as a conservative treatment for patellofemoral pain syndrome by looking at the results of ten moderate to high quality clinical studies and showed that the most effective patellofemoral pain syndrome management included strengthening exercises for the hip at baseline. Due to their role in knee biomechanics, the addition of stretching exercises for the external rotator and abductor muscles, core muscles and proprioceptive, neuromuscular exercises " reduces pain in patellofemoral pain syndrome".
In the light of all these studies, when the literature was examined, very few studies were found that examined the effect of core stabilization exercises in individuals with patellofemoral pain syndrome, and these studies were only studied on certain parameters on women. The aim of this randomized controlled study; To investigate the multifactorial effectiveness of core stabilization exercises applied in patients diagnosed with patellofemoral pain syndrome.
Research Questions and Hypotheses:
What are the effects of core stabilization exercises in patellofemoral pain syndrome? H0: Core stabilization exercises are not effective on pain, functional level, balance, flexibility, muscle strength, normal joint movement, posture in patellofemoral pain syndrome.
H1: effective. Core stabilization exercises are effective on pain, functional level, balance, flexibility, muscle strength, normal joint movement and posture in patellofemoral pain syndrome.
Material and Method:
The study was planned as a randomized controlled trial. The number of volunteers to take part in the study was determined using the G-Power program. In the study, the randomized controlled study of 'Foroughi et al.' 45 named "Effects of Isolated Core Postural Control Training on Knee Pain and Function in Women with Patellofemoral Pain Syndrome: α=0.05, power 80% and effect size 0.3 were taken as an example. As a result of the calculations, it was found that there should be a total of 18 people, 9 people in each group. However, for a good statistical calculation or for the loss of cases, it was decided to take twice the result of this calculation. A total of 40 people, 20 people in each group, will be included in the study.
20/60 years old/with retropatellar pain that occurs during at least two of the activities and persists for at least one month While patients diagnosed with PFPS were included in the study; Patients with meniscus and ligament lesions , osteoarthritis , patellofemoral dislocation and/or subluxation history, osseous anomalies and history of knee surgery , pregnancy status, and patients using analgesics and anti-inflammatory drugs will not be included in the study.
Individuals will be divided into two groups by computerized randomization. Control group; Traditional patellofemoral pain syndrome exercises, (n=20) Core stability group; Core stabilization and hip exercises will be given in addition to traditional patellofemoral pain syndrome exercises. (n=20) After obtaining the demographic information of the cases change, before and after the treatment; Visual analog scale (VAS) change, Kuala scale change, Trunk forward flexion flexibility change, Hamstring muscle flexibility change, Sit-reach test change, Q angle measurement change, Normal joint movement change, McGill stabilization tests change, Timed get up and go test change, Single leg jump test change, Y balance test change, Muscle strength change will be evaluated by the same person using the Corbin Posture analysis change and Foot posture index (FPI) change parameters.
IMPLEMENTATION PROTOCOL
- Control group; traditional patellofemoral pain syndrome exercises; isometric exercises 3 sets of 10 repetitions in one session, balance exercise 30/45 sec, one leg balance exercise 45/60 sec , stretching exercises 4 sets 5 repetitions 20 sec duration, off kinetic chain (CHC) AND open kinetic chain (ACZ) exercises were planned as 3 sets for 4 weeks and 3 days a week .
- Core stability group; In addition to traditional patellofemoral pain syndrome exercises; hip muscle strengthening exercises are 3 sets of 10 repetitions in each session, and (core) stabilization exercises are 1st and 2nd weeks 2 sets 15 repetitions 3rd and 4th weeks 2 sets 5 repetition was planned for 4 weeks and 3 days a week.
While the patients will be exercised with a physiotherapist 1 day a week, the treatment will be followed as a home exercise program 2 days a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Individuals will be divided into two groups by computerized randomization. Control group; Traditional patellofemoral pain syndrome exercises, (n=20) Core stability group; Core stabilization and hip exercises will be given in addition to traditional patellofemoral pain syndrome exercises. (n=20)
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: ExerciseControl group; traditional patellofemoral pain syndrome exercises; isometric exercises 3 sets of 10 repetitions in one session, balance exercise 30/45 sec, one leg balance exercise 45/60 sec , stretching exercises 4 sets 5 repetitions 20 sec duration, off kinetic chain (CHC) AND open kinetic chain (ACZ) exercises were planned as 3 sets for 4 weeks and 3 days a week. |
| Core Stability group | Experimental | Other: ExerciseCore stability group; In addition to traditional patellofemoral pain syndrome exercises; hip muscle strengthening exercises are 3 sets of 10 repetitions in each session, and (core) stabilization exercises are 1st and 2nd weeks 2 sets 15 repetitions 3rd and 4th weeks 2 sets 5 repetition was planned for 4 weeks and 3 days a week. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 20/60 years old/with
- Occur during at least two activities of prolonged sitting, climbing stairs or inclines, squatting, running and jumping
- Retropatellar pain persisting for at least one month
- persons diagnosed with patellofemoral pain syndrome by the doctor are included in the study.
Key exclusion criteria (6 listed)
- Meniscus and ligament lesions
- Osteoarthritis
- patellofemoral dislocation and/or subluxation history
- Osseous anomalies and history of knee surgery
- Pregnancy status
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 |
|---|---|---|
| ExerciseWhile the patients will be exercised with a physiotherapist 1 day a week, the treatment will be followed as a home exercise program 2 days a week. | Other | Control group, Core Stability group |
Primary outcome
Demographic information form change
Time frame: At baseline
The patient's age, height, weight and disease history are questioned.
The visual analogue scale(VAS) change
Time frame: Change from baseline the visual analogue scale at 4 weeks
was described in a psychology journal in 1921. It is a visual scale, not a verbal one. This 11-point scale (from 0 to 10) has different names, but the verbal rating scale (VAS) is most often used. The VAS scoring has a 10 cm long straight line on which the patient can mark the degree of discomfort. For example, when measuring pain, you might have "no pain" on the left end of the line and "worst pain imaginable" on the right, or the like. The result can be read in millimeters (0 - 100 mm), or whole and half a centimeter (0 - 10 cm).
Kuala scale change
Time frame: Change from baseline kuala scale at 4 weeks
Kuala et al. He developed it in 1993 to assess subjective symptoms and functional limitations in PFPS. The score consists of 13 questions. These questions address activity-related pain when climbing stairs, squatting, running, jumping, performing weight-bearing activities, and sitting for long periods of time with the knee flexed. He also questions symptoms such as limping, swelling, patella subluxation, quadriceps muscle atrophy, lack of flexion, and flexion pain. The total score ranges from 0 to 100. A higher score indicates fewer complaints.
Y balance test change
Time frame: Change from baseline Y balance test at 4 weeks
The Y Balance test (YBT) is the most common dynamic balance assessment used in clinical practice and research to evaluate dynamic balance in 3 directions of reach YBT measures dynamic balance during single leg stance and requires strength, proprioception, and flexibility. YBT is a contralateral leg reaching system in one-leg stance anterior (ANT), posterolateral (PL), and posteromedial (PM) directions. A composite score is then calculated by summing the distance reached in 3 directions of reach (ANT, PL, and PM) relative to leg length. It has been reported that YBT predicts injury based on overall access performance (different threshold points depending on the sample) and asymmetry between the limbs (anterior access difference greater than 4 cm). In a study, YBT revealed inter-interpretive test-retest reliability and minimal measurement error.
Body front flexibility assessment change
Time frame: Change from baseline Body front flexibility assessment at 4 weeks
In this test, the person stands on a 15 cm high block and leans forward without bending the knees and tries to touch the fingertip. The test evaluates the flexibility of the lumbar region, hamstring muscles and M. gastrocnemius. The distance between the fingertip and the wooden block surface is measured with a tape measure, and the values that pass the block surface are recorded in cm as positive, and the values below the block surface as negative.
Muscle strength change
Time frame: Change from baseline Muscle strength at 4 weeks
Manual muscle testing does not consistently detect muscle strength deficiencies or clearly demonstrate the impact of such deficiencies on the knee. For this reason, functional performance testing may be preferred. Functional performance tests are a test for the knee and the entire lower extremity. 'Loudon et al.' He evaluated five different functional performance tests (anteromedial lunge, step-down, single-leg press, bilateral squat, balance reaching) in individuals with patellofemoral pain. All five of these tests revealed high reliability and correlated with changes in pain scales. Among these tests as muscle strength assessment in cases; anteromedial lunge, step down (step), balance reaching test will be used. If the patient cannot stabilize the pelvis by standing (on one leg) for 1 minute on the affected leg (the other side pelvis falls), it was decided to perform it on our patients, based on the study, which is said to be a sign of weakness of the hip muscles.
Normal joint movement change
Time frame: Change from baseline Normal joint movement at 4 weeks
Measurement will be made with G-Pro, an Android application. The G-Pro app is a highly accurate reliable tool for measuring knee flexion angle. Its results were found to be more significant and more accurate than the results of conventional instruments . It is preferred because it is easy to apply and has high reliability.
Corbin posture analyses change
Time frame: Change from baseline Corbin posture analyses at 4 weeks
Posture analyses will be performed to determine the changes in the posture of the individuals included in the study. These changes will be scored using the form prepared by Corbin et al. that includes lateral and posterior observations. This form is based on detecting postural disorders by observation made from the two planes mentioned and scoring them according to their severity. The scores will be added last and the postural status will be classified according to the total score. Postural anomalies were scored (0: none, 1: mild, 2: moderate, 3: severe). Postural scores obtained by looking from the lateral and posterior aspects are summed (0-2: excellent, 3-4: very good, 5-7: good, 8-11: moderate, 12≥ bad).
Foot Posture index or (FPI) change
Time frame: Change from baseline Foot posture index at 4 weeks
A six-item assessment scale (Foot Posture index or FPI) was developed in response to the need for a fast, easy and reliable method to measure foot position. The FPI consists of observing the bottom of the hind and forefoot of an individual standing in a relaxed position. The hindfoot is assessed by palpation of the talus head, observing the curves above and below the lateral malleoli, and inversion/eversion of the calcaneus. The forefoot consists of assessing the extent of abduction/adduction of the forefoot in the hindfoot, while checking the swelling in the talo-navicular joint area and the alignment of the medial longitudinal arch.
Assessment of hamstring muscle flexibility change
Time frame: Change from baseline Assessment of hamstring muscle flexibility at 4 weeks
In the supine position, the hip and knee are fixed in 90 degree flexion. The pivot point of the goniometer is placed on the lateral condyle of the femur. The knee angle will be measured by extending the patient's knee with the fixed arm parallel to the lateral midline of the femur and the mobile arm following the fibula. By subtracting the angular value found from 90 degrees, the shortness value will be obtained.
Sit and reach test change
Time frame: Change from baseline Sıt and reach test at 4 weeks
It was used for flexibility assessment. The patients will be asked to sit on the stretcher, with their legs extended and without shoes, and lean the soles of their feet on the front table. Then, the patient is asked to lie forward on the stretcher as much as possible, without flexing his knees, from his torso (waist and hip), and the extreme point where his fingers reach is cm. The best result will be recorded by measuring in terms of and repeating this test 3 times.
Q angle measurement change
Time frame: Change from baseline Q angle measurement at 4 weeks
It will be measured with a goniometer in the supine position, with the hip and knee extended. Between the line drawn from the spina iliaca anterior superior (SiAS) to the middle of the patella and the line drawn from the middle of the patella between the tuberositas tibia, this lateral angle will be measured 3 times and recorded. The average of the measurements will be recorded.
Mcgill stabilization tests change
Time frame: Change from baseline Mcgill stabilization tests at 4 weeks
Endurance tests known as McGill protocol; It was originally developed to evaluate core stabilization in patients with low back pain. This protocol consists of different endurance tests: lateral endurance, trunk flexor endurance, and trunk extensor endurance. In these tests, the time in seconds that the isometric posture is maintained is measured and recorded.
Timed start and go test change
Time frame: Change from baseline Timed start and go test at 4 weeks
The patients will be asked to start from a sitting position in a chair, get up with the given command, walk the predetermined distance of 3 meters as fast as they can, and return to their places. The time from the time they get up from the chair and sit down again will be recorded with the stopwatch. The measurements will be repeated 3 times and the average will be recorded in seconds.
Single leg jump test change
Time frame: Change from baseline Single leg jump test at 4 weeks
The patients begin the test in a position with their hands on their waists on one leg. Patients are asked to jump as far as possible in a parallel plane and land with the same leg. In the tape measure fixed to the ground, the distance between the patient's jump and the starting point is recorded in cm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 23232069Nunes GS, Stapait EL, Kirsten MH, de Noronha M, Santos GM. Clinical test for diagnosis of patellofemoral pain syndrome: Systematic review with meta-analysis. Phys Ther Sport. 2013 Feb;14(1):54-9. doi: 10.1016/j.ptsp.2012.11.003. Epub 2012 Dec 8.
- Background: PubMed 19226237Prins MR, van der Wurff P. Females with patellofemoral pain syndrome have weak hip muscles: a systematic review. Aust J Physiother. 2009;55(1):9-15. doi: 10.1016/s0004-9514(09)70055-8.
- Background: PubMed 16365375Tyler TF, Nicholas SJ, Mullaney MJ, McHugh MP. The role of hip muscle function in the treatment of patellofemoral pain syndrome. Am J Sports Med. 2006 Apr;34(4):630-6. doi: 10.1177/0363546505281808. Epub 2005 Dec 19.
- Background: PubMed 16505640Fredericson M, Yoon K. Physical examination and patellofemoral pain syndrome. Am J Phys Med Rehabil. 2006 Mar;85(3):234-43. doi: 10.1097/01.phm.0000200390.67408.f0.
- Background: PubMed 20508327Magalhaes E, Fukuda TY, Sacramento SN, Forgas A, Cohen M, Abdalla RJ. A comparison of hip strength between sedentary females with and without patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2010 Oct;40(10):641-7. doi: 10.2519/jospt.2010.3120.
- Background: PubMed 19268945Besier TF, Fredericson M, Gold GE, Beaupre GS, Delp SL. Knee muscle forces during walking and running in patellofemoral pain patients and pain-free controls. J Biomech. 2009 May 11;42(7):898-905. doi: 10.1016/j.jbiomech.2009.01.032. Epub 2009 Mar 6.
- Background: PubMed 22562733Steinberg N, Siev-Ner I, Peleg S, Dar G, Masharawi Y, Zeev A, Hershkovitz I. Joint range of motion and patellofemoral pain in dancers. Int J Sports Med. 2012 Jul;33(7):561-6. doi: 10.1055/s-0031-1301330. Epub 2012 May 4.
- Background: PubMed 12355123Tsuji T, Matsuyama Y, Goto M, Yimin Y, Sato K, Hasegawa Y, Ishiguro N. Knee-spine syndrome: correlation between sacral inclination and patellofemoral joint pain. J Orthop Sci. 2002;7(5):519-23. doi: 10.1007/s007760200092.
- Background: PubMed 10569504Juhn MS. Patellofemoral pain syndrome: a review and guidelines for treatment. Am Fam Physician. 1999 Nov 1;60(7):2012-22.
- Background: PubMed 23274607Noehren B, Hamill J, Davis I. Prospective evidence for a hip etiology in patellofemoral pain. Med Sci Sports Exerc. 2013 Jun;45(6):1120-4. doi: 10.1249/MSS.0b013e31828249d2.
- Background: PubMed 18078506Kettunen JA, Harilainen A, Sandelin J, Schlenzka D, Hietaniemi K, Seitsalo S, Malmivaara A, Kujala UM. Knee arthroscopy and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomized controlled trial. BMC Med. 2007 Dec 13;5:38. doi: 10.1186/1741-7015-5-38.
- Background: PubMed 25082920Clijsen R, Fuchs J, Taeymans J. Effectiveness of exercise therapy in treatment of patients with patellofemoral pain syndrome: systematic review and meta-analysis. Phys Ther. 2014 Dec;94(12):1697-708. doi: 10.2522/ptj.20130310. Epub 2014 Jul 31.
- 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.
Berrak VARHAN, Assoc. Prof. study director
Ethics committee protocol number 21-128
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 Istinye 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 4 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. 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?
Results are not available in the source record.
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?
Demographic information form change (time frame: At baseline). The study lists 15 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 NCT05351814, which also lists 36 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 28 Apr 2022.