Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05261100
Other study ID # ULahore Hassan javed
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2021
Est. completion date May 8, 2022

Study information

Verified date June 2022
Source University of Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare the effects of routine physical therapy with and without core stability exercises on pain and range of motion, in patients with patellofemoral pain syndrome. The spine, abdominal region, pelvis, hips, and proximal lower extremities, are defined as the core of the body. The effects of core muscle strengthening have been proven as an effective method of management in various cases. The knee is the frequently injured joint in core instability with the decreased hip strength. Deficiency in the control of the neuromuscular system of the body's trunk or "core" may affect the stability of the lower extremity, which can lead to injury in the tibiofemoral or patellofemoral joints.


Description:

The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women without any structural changes such as increased Q-angle or significant pathological changes in articular cartilage. Patellofemoral pain syndrome (PFPS) is the most common overuse syndrome in athletes. Patellofemoral pain is more common among female athletes especially adolescents and young adults. Symptoms include: persistent pain behind the patella or peripatellar. Pain increases on ascending and descending stairs and squatting and prolonged sitting. Patellofemoral Pain Syndrome (PFPS) is a common musculoskeletal disorder typically occurring in physically active people aged 40 years and younger, causing pain, functional deficits and lower limb weakness. Traditional treatment has been aimed at strengthening the knee, however recent research suggests the muscles around the hip also play an important role in the development and continuity of Patellofemoral Pain Syndrome. Patellofemoral pain (PFP) is pain in the peripatellar/retropatellar region that aggravates with physical activities such as squatting, stair climbing, running and jumping or sitting for prolonged periods of time. It is the most common source of anterior knee ailment in active adolescents and young adults and is much more prevalent in women than men. Patellofemoral pain (PFP) is a very common problem in athletes who participate in jumping sports. Several risk factors may play a part in the pathogenesis of PFP. Overuse, trauma and intrinsic risk factors are particularly important among athletes. Physical examination has a key role in PFP diagnosis. common risk factors should be investigated, such as hip muscle dysfunction, poor core muscle endurance, muscular tightness, excessive foot pronation and patellar malalignment. Studies conducted on core muscle strengthening exercises program for the management of pain in hip, quadriceps region and ankle joint but limited studies were conducted in patient with patellofemoral pain syndrome. There is a need to compare the effectiveness of routine physiotherapy with and without core stability exercises in patient with patellofemoral pain syndrome. This study is intended to determine the effectiveness of core muscle strengthening exercises for the management of patellofemoral pain syndrome. The spine, abdominal region, pelvis, hips, and proximal lower extremities, are defined as the core of the body. The effects of core muscle strengthening have been proven as an effective method of management in various cases. The knee is the frequently injured joint in core instability with the decreased hip strength. Deficiency in the control of the neuromuscular system of the body's trunk or "core" may affect the stability of the lower extremity, which can lead to injury in the tibiofemoral or patellofemoral joints.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date May 8, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - • Age between 18-40 Years - Both Gender - Patient with Anterior knee pain for at least 4 weeks Exclusion Criteria: - • History of trauma ,fracture of spine and lower extremity - History of any congenital deformity - History of lumbar radiculopathy - History of hip osteoarthritis - History of rheumatoid arthritis - History of Any surgical procedure involving lumber or lower extremity

Study Design


Intervention

Other:
Core stability exercises
Moist heating pads will be applied on knee joint for 10 minutes before each treatment session. Apply TENS on knee joint for 10 minutes treatment session. Knee Isometric exercises will be performed along with core stability exercises..
Conventional Physical Therapy
Moist heating pads will be applied on knee joint for 10 minutes before each treatment session. Apply TENS on knee joint for 10 minutes treatment session. Knee Isometric exercise perform.

Locations

Country Name City State
Pakistan PSRD hospital lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (16)

Bolgla LA, Malone TR, Umberger BR, Uhl TL. Hip strength and hip and knee kinematics during stair descent in females with and without patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2008 Jan;38(1):12-8. doi: 10.2519/jospt.2008.2462. Epub 2007 Nov 21. — View Citation

Callaghan MJ, Selfe J, McHenry A, Oldham JA. Effects of patellar taping on knee joint proprioception in patients with patellofemoral pain syndrome. Man Ther. 2008 Jun;13(3):192-9. Epub 2007 Feb 12. — View Citation

Eng JJ, Pierrynowski MR. Evaluation of soft foot orthotics in the treatment of patellofemoral pain syndrome. Phys Ther. 1993 Feb;73(2):62-8; discussion 68-70. Erratum in: Phys Ther 1993 May;73(5):330. — View Citation

Halabchi F, Abolhasani M, Mirshahi M, Alizadeh Z. Patellofemoral pain in athletes: clinical perspectives. Open Access J Sports Med. 2017 Oct 9;8:189-203. doi: 10.2147/OAJSM.S127359. eCollection 2017. Review. — View Citation

Ireland ML, Willson JD, Ballantyne BT, Davis IM. Hip strength in females with and without patellofemoral pain. J Orthop Sports Phys Ther. 2003 Nov;33(11):671-6. — View Citation

Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25. — View Citation

LaBella C. Patellofemoral pain syndrome: evaluation and treatment. Prim Care. 2004 Dec;31(4):977-1003. — View Citation

Lankhorst NE, Bierma-Zeinstra SM, van Middelkoop M. Factors associated with patellofemoral pain syndrome: a systematic review. Br J Sports Med. 2013 Mar;47(4):193-206. doi: 10.1136/bjsports-2011-090369. Epub 2012 Jul 19. Review. — View Citation

Lee JH, Jang KM, Kim E, Rhim HC, Kim HD. Effects of Static and Dynamic Stretching With Strengthening Exercises in Patients With Patellofemoral Pain Who Have Inflexible Hamstrings: A Randomized Controlled Trial. Sports Health. 2021 Jan/Feb;13(1):49-56. doi: 10.1177/1941738120932911. Epub 2020 Aug 13. — View Citation

Motealleh A, Kordi Yoosefinejad A, Ghoddosi M, Azhdari N, Pirouzi S. Trunk postural control during unstable sitting differs between patients with patellofemoral pain syndrome and healthy people: A cross-sectional study. Knee. 2019 Jan;26(1):26-32. doi: 10.1016/j.knee.2018.10.002. Epub 2018 Nov 22. — View Citation

Petersen W, Ellermann A, Gösele-Koppenburg A, Best R, Rembitzki IV, Brüggemann 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. Review. — View Citation

Powers CM, Landel R, Sosnick T, Kirby J, Mengel K, Cheney A, Perry J. The effects of patellar taping on stride characteristics and joint motion in subjects with patellofemoral pain. J Orthop Sports Phys Ther. 1997 Dec;26(6):286-91. — View Citation

Smith BE, Selfe J, Thacker D, Hendrick P, Bateman M, Moffatt F, Rathleff MS, Smith TO, Logan P. Incidence and prevalence of patellofemoral pain: A systematic review and meta-analysis. PLoS One. 2018 Jan 11;13(1):e0190892. doi: 10.1371/journal.pone.0190892. eCollection 2018. Review. — View 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. Epub 2005 Dec 19. — View Citation

Xu X, Yao C, Wu R, Yan W, Yao Y, Song K, Jiang Q, Shi D. Prevalence of patellofemoral pain and knee pain in the general population of Chinese young adults: a community-based questionnaire survey. BMC Musculoskelet Disord. 2018 May 24;19(1):165. doi: 10.1186/s12891-018-2083-x. — View Citation

Yañez-Álvarez A, Bermúdez-Pulgarín B, Hernández-Sánchez S, Albornoz-Cabello M. Effects of exercise combined with whole body vibration in patients with patellofemoral pain syndrome: a randomised-controlled clinical trial. BMC Musculoskelet Disord. 2020 Aug 28;21(1):582. doi: 10.1186/s12891-020-03599-2. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Pain (Visual Analogue Scale) The visual analogue scale is a simple and commonly used way for the assessment of variations in intensity of pain. In clinical practice the ratio of pain relief, evaluated by VAS, is frequently considered as a measure of the efficacy of treatment. VAS range is 0-10. It's a categorical scale with 0-4 mild pain, 4-7 moderate or distressing pain while 7-10 unbearable pain30. In this study inclusion criteria will be categorically 0-7 score, mild & moderate pain intensity on VAS. Use is scale for intensity of pain.
Total eight treatment sessions will be given to each patient, and pre-treatment assessment will be done on very first day. Second assessment will be done on fourth treatment session, and final assessment will be on eighth treatment session.
6 weeks
Primary Range of Motion (Goniometer) A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM). There are two "arms"-one that is stationary and one that is movable-that are hinged together.
In order to assess the range of knee joint, goniometer will be used. Stationary arm will be placed on lateral epicondyle of the femur, movement arm along the fibula to lateral malleolus.
Total eight treatment sessions will be given to each patient, and pre-treatment assessment will be done on very first day. Second assessment will be done on fourth treatment session, and final assessment will be on eighth treatment session.
6 weeks
Primary Lower extremity functional scale (LEFS) The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The resultant AKPS is a 13-item self-report questionnaire that evaluates subjective responses to specific activities and symptoms that are thought to correlate with anterior knee pain syndrome. The AKPS is scored from a minimum score of 0 to a maximum score of 100 points. This scale used for function of lower limb.
Total eight treatment sessions will be given to each patient, and pre-treatment assessment will be done on very first day. Second assessment will be done on fourth treatment session, and final assessment will be on eighth treatment session.
6 weeks
Primary Anterior knee pain scale (AKPS) The resultant AKPS is a 13-item self-report questionnaire that evaluates subjective responses to specific activities and symptoms that are thought to correlate with anterior knee pain syndrome. The AKPS is scored from a minimum score of 0 to a maximum score of 100 points. This scale used for daily living performance status Total eight treatment sessions will be given to each patient, and pre-treatment assessment will be done on very first day. Second assessment will be done on fourth treatment session, and final assessment will be on eighth treatment session. 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT04538508 - Radiofrecuency and Supervised Exercise Versus Supervised Exercise in the Treatment of Patellofemoral Pain Syndrome. N/A
Completed NCT03685812 - Validity and Reliability of Autocad Software Assessment of JPS in PFPS
Completed NCT02873143 - 5 Year Follow-up of Adolescents With Knee Pain N/A
Active, not recruiting NCT02114294 - Hip Strengthening Versus Quadriceps Based Training for Patellofemoral Pain Syndrome N/A
Completed NCT02243332 - Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain N/A
Completed NCT01696162 - Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence "Virtual Therapy" for Anterior Knee Pain N/A
Completed NCT01434966 - Changes in Quadriceps Function Following Local or Distant Interventions in Individuals With Patellofemoral Pain N/A
Not yet recruiting NCT05327569 - The Efficacy of Myofascial Chain Release Techniques in Patients With Patellofemoral Pain Syndrome. N/A
Completed NCT06060730 - Measurement Properties of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS
Completed NCT03281421 - Immediate Effects of Ankle Mobilization on Dorsiflexion Range of Motion in Women With Patellofemoral Pain. N/A
Recruiting NCT06130696 - Clamshell Exercise in Patellofemoral Syndrome. N/A
Completed NCT03201133 - Clinical Subgroups in Patellofemoral Pain Syndrome
Completed NCT05959148 - Adjuvant Effects of Monochromatic Infrared Energy in Rehabilitation of Adolescents With Patellofemoral Pain Syndrome N/A
Completed NCT02646579 - Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only N/A
Completed NCT00978003 - Vasti Control of Patellofemoral Kinematics in Asymptomatic Volunteer
Not yet recruiting NCT04631614 - Addition Effect of the Ankle Manual Therapy to Muscle Strengthening Exercise in Women With Patellofemoral Pain N/A
Not yet recruiting NCT05383781 - Effect of Short Foot Exercise in Treatment of Patients With Patellofemoral Pain Syndrome N/A
Not yet recruiting NCT05083897 - Effect of Hip Adductors Isometric Contraction on Knee Extensors Isokinetic Torque in Patellofemoral Pain Syndrome
Withdrawn NCT03157271 - The Addition of Dry Needling in the Treatment of Patients With Patellofemoral Pain Syndrome N/A
Enrolling by invitation NCT02548988 - Selective Neuromuscular Electrical Stimulation on VMO N/A