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Completed

NCT Number: NCT05120583

Pilates-based Core Strengthening on Patellofemoral Pain Syndrome

Patellofemoral pain syndrome (PFPS) is one of the most common musculoskeletal pain conditions that tend to become a chronic problem. PFPS is common among young adolescents, particularly in physically active individuals aged 12 to 17 years old with more prevalence among females, as it affects females 1.5 - 3 times when compared to males.

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Key information

Conditions

Patellofemoral Pain Syndrome Joint Diseases Musculoskeletal Diseases

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

Al Kharj, Riyadh Region, Saudi Arabia

About this study

Adolescents with PFPS usually complain of retro-patellar pain (behind the kneecap) or peripatellar pain (around the kneecap) and crepitation in the knee joint, and also there is discomfort while sitting with a flexed knee for a long time. Symptoms are usually exacerbated by activities that increase the load on patellofemoral joints such as weight-bearing activities, squatting, walking up or downstairs, and running.

PFPS takes place whenever the muscles around the knee fail to keep the kneecap properly aligned, leading to abnormal lateral tracking of the patella.Overuse such as running and jumping sports, the trauma of kneecaps such as fracture, dislocation, or knee surgery may also predispose to PFPS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pain felt anterior to knee joint.
  • Pain felt retro-patellar.
  • Pain felt during rest and increased with activities like prolonged sitting, squatting, running, and stair climbing.
  • Insidious onset lasting for more than 6 weeks.
  • Without any traumatic incidence.
  • Not participating in a physical therapy program for the past three months.

Exclusion criteria

  • If they had a meniscal tear.
  • Cruciate/collateral ligaments involvement.
  • Knee osteoarthritis.
  • Rheumatoid arthritis.
  • A history of knee or hip surgery.
  • Patellar dislocation/subluxation.
  • Traction apophysitis encompassing the patellofemoral complex.
  • Any pathology in the patellar tendon.
  • Spinal referred pain.

Treatment and study plan

Pilates exercises

Other

Side kick internal/ external rotation with Pilate's band

Other names: Pilates band

Traditional physical therapy program

Other

strength, flexibility

Other names: strengthening exercises

Primary outcomes

  1. Pain assessment

    Time frame: at baseline

    assessed by using a visual analog scale, 10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation

  2. Pain assessment

    Time frame: after 12 weeks

    assessed by using a visual analog scale,10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation

  3. Muscle strength assessment

    Time frame: at baseline

    assessed using a calibrated handheld dynamometer

  4. Muscle strength assessment

    Time frame: after 12 weeks

    assessed using a calibrated handheld dynamometer

Secondary outcomes

  1. Functional status

    Time frame: at baseline

    evaluated using the Arabic version of the Anterior Knee pain Questionnaire, The score ranges from 0 to 100, with 0 indicating complete functional limitation and 100 indicating no pain and no functional limitation.

  2. Functional status

    Time frame: after 12 weeks

    evaluated using the Arabic version of the Anterior Knee pain Questionnaire, The score ranges from 0 to 100, with 0 indicating complete functional limitation and 100 indicating no pain and no functional limitation.

  3. health-related quality of life

    Time frame: at baseline

    assessed by using the self-report Pediatric Quality of Life Inventory, it includes 23 items distributed among 4 domains [physical (8 items), emotional (5 items), social (5 items), and school functions (3 items)]. Each item is rated on a 5- points scale (0 means never, and 4 means almost always). Items are transformed linearly to 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0).

  4. health-related quality of life

    Time frame: after 12 weeks

    assessed by using the self-report Pediatric Quality of Life Inventory, it includes 23 items distributed among 4 domains [physical (8 items), emotional (5 items), social (5 items), and school functions (3 items)]. Each item is rated on a 5- points scale (0 means never, and 4 means almost always). Items are transformed linearly to 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0).

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Collaborators

  • Cairo University
  • Prince Sattam Bin Abdulaziz University

Registry information

Official study title

Incorporation of Pilates-based Core Strengthening Exercises Into the Rehabilitation Protocol for Adolescents With Patellofemoral Pain Syndrome: a Randomized Clinical Trial

Acronym: Pilates

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 15, 2021
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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