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Patellofemoral Pain SyndromeNCT05261100

Effects of Core Stability Exercises in Patients With Patellofemoral Pain Syndrome

A study testing Core stability exercises and Conventional Physical Therapy in people with Patellofemoral Pain Syndrome, run by University of Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Patellofemoral Pain Syndrome
What is being tested?
Core stability exercises and Conventional Physical Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 sitePakistan
Study dates
11 Nov 2021to 8 May 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 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • • Age between 18-40 Years
  • Both Gender
  • Patient with Anterior knee pain for at least 4 weeks

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • PSRD hospital lahore

    Lahore, Punjab Province, 54770

Other trials in Pakistan

About this study

Official title: Effects of Routine Physical Therapy With and Without Core Stability Exercises in Patients With Patellofemoral Pain Syndrome -a Randomized Controlled Trial

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.

Read the detailed 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.

Being tested
Core stability exercises, Conventional Physical Therapy
Keywords
Patellofemoral Pain Syndrome, Core stability
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.

  • Core stability exercisesOther

    Also called 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 exercises will be performed along with core stability exercises..

  • Conventional Physical TherapyOther

    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.

Study groups in NCT05261100
Study groupRoleWhat they receive
Active groupPlacebo comparatorConventional Physical therapy
Receives: Other: Conventional Physical Therapy
Experimental groupExperimentalConventional Physical therapy with Core stability
Receives: Other: Core stability exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start11 Nov 2021
  3. Primary completion15 Mar 2022
  4. Study completion8 May 2022

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05261100
Sponsor's protocol ID
ULahore Hassan javed
Status last verified
Jun 2022
First submitted
19 Feb 2022
Last updated
28 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24221245
  • Yanez-Alvarez A, Bermudez-Pulgarin B, Hernandez-Sanchez 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.

    PubMed 32859183
  • 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.

    PubMed 29070955
  • 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.

    PubMed 29324820
  • 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.

    PubMed 32790575
  • 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.

    PubMed 29793456
  • 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.

    PubMed 22815424
  • 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. doi: 10.1093/ptj/73.2.62.

    PubMed 8421719
  • LaBella C. Patellofemoral pain syndrome: evaluation and treatment. Prim Care. 2004 Dec;31(4):977-1003. doi: 10.1016/j.pop.2004.07.006.

    PubMed 15544830
  • 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. doi: 10.2519/jospt.1997.26.6.286.

    PubMed 9402564
  • 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.

    PubMed 16365375
  • 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.

    PubMed 30472048
  • 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.

    PubMed 22027216
  • 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.

    PubMed 18349475
  • 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. doi: 10.2519/jospt.2003.33.11.671.

    PubMed 14669962

Questions about this trial

What is this clinical trial studying?

A study testing Core stability exercises and Conventional Physical Therapy in people with Patellofemoral Pain Syndrome, run by University of Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 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 Pakistan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (Visual Analogue Scale) (time frame: 6 weeks). The study lists 4 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 NCT05261100, which also lists 16 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 Jun 2022.

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