Clinical trial NCT05351814: Effectiveness Of Core Stabilization Exercises In Patellofemoral Pain Syndrome
Official title: The Effect Of Core Stabilization Exercises In Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: Core Stability
Patellofemoral Pain
Exercise Therapy
Core Balance
Flexibility
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

Brief 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.

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

1. 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 .
2. 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

1. 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 .
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Demographic information form change
timeFrame: At baseline
measure: The visual analogue scale(VAS) change
timeFrame: Change from baseline the visual analogue scale at 4 weeks
measure: Kuala scale change
timeFrame: Change from baseline kuala scale at 4 weeks
measure: Y balance test change
timeFrame: Change from baseline Y balance test at 4 weeks
measure: Body front flexibility assessment change
timeFrame: Change from baseline Body front flexibility assessment at 4 weeks
measure: Muscle strength change
timeFrame: Change from baseline Muscle strength at 4 weeks
measure: Normal joint movement change
timeFrame: Change from baseline Normal joint movement at 4 weeks
measure: Corbin posture analyses change
timeFrame: Change from baseline Corbin posture analyses at 4 weeks
measure: Foot Posture index or (FPI) change
timeFrame: Change from baseline Foot posture index at 4 weeks
measure: Assessment of hamstring muscle flexibility change
timeFrame: Change from baseline Assessment of hamstring muscle flexibility at 4 weeks
measure: Sit and reach test change
timeFrame: Change from baseline Sıt and reach test at 4 weeks
measure: Q angle measurement change
timeFrame: Change from baseline Q angle measurement at 4 weeks
measure: Mcgill stabilization tests change
timeFrame: Change from baseline Mcgill stabilization tests at 4 weeks
measure: Timed start and go test change
timeFrame: Change from baseline Timed start and go test at 4 weeks
measure: Single leg jump test change
timeFrame: Change from baseline Single leg jump test at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University
state: Maltepe
Study officials:
affiliation: Ethics committee protocol number 21-128
name: Berrak VARHAN, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Prins 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.
citation: Tyler 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.
citation: Fredericson 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.
citation: Magalhaes 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.
citation: Besier 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.
citation: Steinberg 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.
citation: Tsuji 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.
citation: Juhn MS. Patellofemoral pain syndrome: a review and guidelines for treatment. Am Fam Physician. 1999 Nov 1;60(7):2012-22.
citation: Noehren 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.
citation: Kettunen 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.
citation: Clijsen 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.
citation: Alaca 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.
citation: Fukuda 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.
citation: Ismail 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.
citation: Motealleh A, Mohamadi M, Moghadam MB, Nejati N, Arjang N, Ebrahimi N. Effects of Core Neuromuscular Training on Pain, Balance, and Functional Performance in Women With Patellofemoral Pain Syndrome: A Clinical Trial. J Chiropr Med. 2019 Mar;18(1):9-18. doi: 10.1016/j.jcm.2018.07.006. Epub 2019 Feb 10.
citation: Chevidikunnan MF, Al Saif A, Gaowgzeh RA, Mamdouh KA. Effectiveness of core muscle strengthening for improving pain and dynamic balance among female patients with patellofemoral pain syndrome. J Phys Ther Sci. 2016 May;28(5):1518-23. doi: 10.1589/jpts.28.1518. Epub 2016 May 31.
citation: Boling MC, Bolgla LA, Mattacola CG, Uhl TL, Hosey RG. Outcomes of a weight-bearing rehabilitation program for patients diagnosed with patellofemoral pain syndrome. Arch Phys Med Rehabil. 2006 Nov;87(11):1428-35. doi: 10.1016/j.apmr.2006.07.264.
citation: Alba-Martin P, Gallego-Izquierdo T, Plaza-Manzano G, Romero-Franco N, Nunez-Nagy S, Pecos-Martin D. Effectiveness of therapeutic physical exercise in the treatment of patellofemoral pain syndrome: a systematic review. J Phys Ther Sci. 2015 Jul;27(7):2387-90. doi: 10.1589/jpts.27.2387. Epub 2015 Jul 22.
citation: Rabelo ND, Lima B, Reis AC, Bley AS, Yi LC, Fukuda TY, Costa LO, Lucareli PR. Neuromuscular training and muscle strengthening in patients with patellofemoral pain syndrome: a protocol of randomized controlled trial. BMC Musculoskelet Disord. 2014 May 16;15:157. doi: 10.1186/1471-2474-15-157.
citation: Song CY, Lin YF, Wei TC, Lin DH, Yen TY, Jan MH. Surplus value of hip adduction in leg-press exercise in patients with patellofemoral pain syndrome: a randomized controlled trial. Phys Ther. 2009 May;89(5):409-18. doi: 10.2522/ptj.20080195. Epub 2009 Mar 19.
citation: Osteras B, Osteras H, Torstensen TA. Long-term effects of medical exercise therapy in patients with patellofemoral pain syndrome: results from a single-blinded randomized controlled trial with 12 months follow-up. Physiotherapy. 2013 Dec;99(4):311-6. doi: 10.1016/j.physio.2013.04.001. Epub 2013 Jun 10.
citation: Moyano FR, Valenza MC, Martin LM, Caballero YC, Gonzalez-Jimenez E, Demet GV. Effectiveness of different exercises and stretching physiotherapy on pain and movement in patellofemoral pain syndrome: a randomized controlled trial. Clin Rehabil. 2013 May;27(5):409-17. doi: 10.1177/0269215512459277. Epub 2012 Oct 4.
citation: Halabchi F, Mazaheri R, Mansournia MA, Hamedi Z. Additional Effects of an Individualized Risk Factor-Based Approach on Pain and the Function of Patients With Patellofemoral Pain Syndrome: A Randomized Controlled Trial. Clin J Sport Med. 2015 Nov;25(6):478-86. doi: 10.1097/JSM.0000000000000177.
citation: Ummels PE, Lenssen AF, Barendrecht M, Beurskens AJ. Reliability of the Dutch translation of the Kujala Patellofemoral Score Questionnaire. Physiother Res Int. 2017 Jan;22(1). doi: 10.1002/pri.1649. Epub 2015 Aug 26.
citation: Kuru T, Dereli EE, Yaliman A. Validity of the Turkish version of the Kujala patellofemoral score in patellofemoral pain syndrome. Acta Orthop Traumatol Turc. 2010;44(2):152-6. doi: 10.3944/AOTT.2010.2252.
citation: Chimera NJ, Smith CA, Warren M. Injury history, sex, and performance on the functional movement screen and Y balance test. J Athl Train. 2015 May;50(5):475-85. doi: 10.4085/1062-6050-49.6.02. Epub 2015 Mar 11.
citation: Engquist KD, Smith CA, Chimera NJ, Warren M. Performance Comparison of Student-Athletes and General College Students on the Functional Movement Screen and the Y Balance Test. J Strength Cond Res. 2015 Aug;29(8):2296-303. doi: 10.1519/JSC.0000000000000906.
citation: Shaffer SW, Teyhen DS, Lorenson CL, Warren RL, Koreerat CM, Straseske CA, Childs JD. Y-balance test: a reliability study involving multiple raters. Mil Med. 2013 Nov;178(11):1264-70. doi: 10.7205/MILMED-D-13-00222.
citation: Loudon JK, Wiesner D, Goist-Foley HL, Asjes C, Loudon KL. Intrarater Reliability of Functional Performance Tests for Subjects With Patellofemoral Pain Syndrome. J Athl Train. 2002 Sep;37(3):256-261.
citation: Petersen W, Ellermann A, Gosele-Koppenburg A, Best R, Rembitzki IV, Bruggemann GP, Liebau C. Patellofemoral pain syndrome. Knee Surg Sports Traumatol Arthrosc. 2014 Oct;22(10):2264-74. doi: 10.1007/s00167-013-2759-6. Epub 2013 Nov 13.
citation: Melian-Ortiz A, Varillas-Delgado D, Laguarta-Val S, Rodriguez-Aparicio I, Senent-Sansegundo N, Fernandez-Garcia M, Roger-de Ona I. [Reliability and concurrent validity of the app Goniometer Pro vs Universal Goniometer in the determination of passive knee flexion]. Acta Ortop Mex. 2019 Jan-Feb;33(1):18-23. Spanish.
citation: Redmond AC, Crane YZ, Menz HB. Normative values for the Foot Posture Index. J Foot Ankle Res. 2008 Jul 31;1(1):6. doi: 10.1186/1757-1146-1-6.
citation: Bliss LS, Teeple P. Core stability: the centerpiece of any training program. Curr Sports Med Rep. 2005 Jun;4(3):179-83. doi: 10.1007/s11932-005-0064-y.
citation: Ferber R, Bolgla L, Earl-Boehm JE, Emery C, Hamstra-Wright K. Strengthening of the hip and core versus knee muscles for the treatment of patellofemoral pain: a multicenter randomized controlled trial. J Athl Train. 2015 Apr;50(4):366-77. doi: 10.4085/1062-6050-49.3.70. Epub 2014 Nov 3.
citation: Foroughi F, Sobhani S, Yoosefinejad AK, Motealleh A. Added Value of Isolated Core Postural Control Training on Knee Pain and Function in Women With Patellofemoral Pain Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Feb;100(2):220-229. doi: 10.1016/j.apmr.2018.08.180. Epub 2018 Sep 26.