NCT06130696

Brief Summary

Patellofemoral pain syndrome (PFPS), also known as runner's knee, is a common knee condition characterized by pain and discomfort in the front of the knee, specifically around the patella (kneecap) and the surrounding area. The causes for anterior knee pain are multifactorial like overuse, muscle imbalances abnormal tracking of the patella, biomechanical issues, and improper alignment of the lower limbs. Activities that involve repetitive knee motion, such as running, jumping, squatting, or climbing stairs, can exacerbate the condition . The PFPS may cause aching pain around the front of the knee , especially when sitting for long periods, squatting, or climbing stairs, Pain worsens with activities that involve bending the knee, popping or grinding sensation in the knee and swelling or inflammation around the knee in some cases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 9, 2023

Last Update Submit

November 13, 2023

Conditions

Patellofemoral Pain Syndrome

Keywords

Clamshell exercises.PainPatellofemoral pain syndromeFunctionAthelete

Outcome Measures

Primary Outcomes (3)

  • Kujala patellar scale. (Pain )

    diagnostic tool that aims to assess the severity of symptoms and physical limitations in patients with patellofemoral pain syndrome (PFPS). 13-item self-questionnaire that assesses to limitation physical activities and symptoms that are known to correlate with anterior knee pain syndrome. This scle consist 0 - 100 score. Less than 90 shows physcial limitation or pain at patellar site. While 98 or 100 shows good knee with no pain or limitation.

    4th day

  • Goniometer. (ROM)

    Goniometer is used to measure the range of motion of joint. For knee joint, flexion ranges between 0-135º and extension ranges between 135-0º.

    4th day

  • Functional mobility test ( physical activity / function)

    Functional mobility test: Functional movement screen (FMS) is an evaluation tool for whom movement is a key part of exercise. FMS consists of 7 movement pattern and 3 three clearing tests assess pain for shoulder rotation motions, trunk extension, and trunk flexion. The FMS is scored on an ordinal scale, with 4 possible scores ranging from 0 to 3. 'Zero' refers if the individual has pain during any part of the movement. '1' represents that the person is unable to complete the movement pattern, '2' represents the ability to complete the movement with compensation and '3' refers that the person completes the movement without compensation

    4th day

Secondary Outcomes (3)

  • Manual muscle testing.

    4th week

  • Numeric pain rating scale.

    4th week

  • Visual analogue scale

    4th week.

Study Arms (2)

Clamshell exercise

EXPERIMENTAL

Clamshell exercise

Other: Clamshell exercises

strengthening exercises with clamshell exercise

ACTIVE COMPARATOR

Isometric and muscle strengthening exercises with clamshell exercise.

Other: Isometric and muscle strengthen exercise

Interventions

Clamshell exercisesOTHER

Group A will receive treatment with Clamshell exercises Change sides and do 3 sets. Total of 6 session were given.

Clamshell exercise
Isometric and muscle strengthen exerciseOTHER

group B will receive simple exercises also with clamshell 10 to 20 times. Change sides and do 3 sets. Total 6 session were given

strengthening exercises with clamshell exercise

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients have at least three months history of peri- or retropatellar pain with worst pain intensity during previous week of VAS 3 or more.
  • Players with complain of knee pain.
  • Individual having pain during compression of the patella, palpation of the patellar facets

You may not qualify if:

  • Any degenerative changes of the knee or hip.
  • History of patellar dislocation.
  • Evidence of edema, Osgood-Schlatter disease or Sinding-Larsen-Johanssen syndrome, patellar -tendinopathy, chondral injury, osteoarthritis.
  • Joint or muscle injuries in the hip, lumbar pain, sacroiliac pain.
  • Patients who previously received surgical treatment in the knee or hip joints, and bilateral complaint of anterior knee pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Sports Board

Lahore, Punjab Province, 6666, Pakistan

RECRUITING

Related Publications (6)

  • Boling M, Padua D, Marshall S, Guskiewicz K, Pyne S, Beutler A. Gender differences in the incidence and prevalence of patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Oct;20(5):725-30. doi: 10.1111/j.1600-0838.2009.00996.x.

    PMID: 19765240BACKGROUND

  • Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.

    PMID: 17549951BACKGROUND

  • Pereira PM, Baptista JS, Conceicao F, Duarte J, Ferraz J, Costa JT. Patellofemoral Pain Syndrome Risk Associated with Squats: A Systematic Review. Int J Environ Res Public Health. 2022 Jul 28;19(15):9241. doi: 10.3390/ijerph19159241.

    PMID: 35954598BACKGROUND

  • Fang B, Kim YH, Choi MY. Effects of High-Intensity Aquatic or Bicycling Training in Athletes with Unilateral Patellofemoral Pain Syndrome. Int J Environ Res Public Health. 2022 Apr 13;19(8):4675. doi: 10.3390/ijerph19084675.

    PMID: 35457543BACKGROUND

  • Al-Hakim W, Jaiswal PK, Khan W, Johnstone D. The non-operative treatment of anterior knee pain. Open Orthop J. 2012;6:320-6. doi: 10.2174/1874325001206010320. Epub 2012 Jul 27.

    PMID: 22896779BACKGROUND

  • Campbell SA, Valier AR. The Effect of Kinesio Taping on Anterior Knee Pain Consistent With Patellofemoral Pain Syndrome: A Critically Appraised Topic. J Sport Rehabil. 2016 Aug;25(3):288-93. doi: 10.1123/jsr.2014-0278. Epub 2015 May 6.

    PMID: 25946512BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain SyndromePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aruba Saeed, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anosh Malik, MS-SPT.

CONTACT

03027427342anoshmalik7864@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

September 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)