NCT05261100

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

February 19, 2022

Last Update Submit

June 25, 2022

Conditions

Keywords

Patellofemoral Pain SyndromeCore stability

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Active group

PLACEBO COMPARATOR

Conventional Physical therapy

Other: Conventional Physical Therapy

Experimental group

EXPERIMENTAL

Conventional Physical therapy with Core stability

Other: Core stability exercises

Interventions

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..

Also known as: Conventional Physical Therapy
Experimental group

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.

Active group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSRD hospital lahore

Lahore, Punjab Province, 54770, Pakistan

Location

Related Publications (16)

  • 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.

    PMID: 24221245BACKGROUND
  • 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.

    PMID: 32859183BACKGROUND
  • 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.

    PMID: 29070955BACKGROUND
  • 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.

    PMID: 29324820BACKGROUND
  • 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.

    PMID: 32790575BACKGROUND
  • 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.

    PMID: 29793456BACKGROUND
  • 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.

    PMID: 22815424BACKGROUND
  • 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.

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

    PMID: 15544830BACKGROUND
  • 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.

    PMID: 9402564BACKGROUND
  • 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.

    PMID: 16365375BACKGROUND
  • 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.

    PMID: 30472048BACKGROUND
  • 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.

    PMID: 22027216BACKGROUND
  • 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.

    PMID: 18349475BACKGROUND
  • 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.

    PMID: 14669962BACKGROUND
  • 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. doi: 10.1016/j.math.2006.11.004. Epub 2007 Feb 12.

    PMID: 17296323BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • hassan javed, M.Phil(MSK)

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2022

First Posted

March 2, 2022

Study Start

November 11, 2021

Primary Completion

March 15, 2022

Study Completion

May 8, 2022

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations