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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05120583
Other study ID # RHPT/20/0049
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date October 30, 2021

Study information

Verified date November 2021
Source Qassim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date October 30, 2021
Est. primary completion date August 20, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years to 17 Years
Eligibility 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.

Study Design


Intervention

Other:
Pilates exercises
Side kick internal/ external rotation with Pilate's band
Traditional physical therapy program
strength, flexibility

Locations

Country Name City State
Saudi Arabia Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University Al-Kharj Riyadh

Sponsors (3)

Lead Sponsor Collaborator
Qassim University Cairo University, Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

Park SK, Stefanyshyn DJ. Greater Q angle may not be a risk factor of patellofemoral pain syndrome. Clin Biomech (Bristol, Avon). 2011 May;26(4):392-6. doi: 10.1016/j.clinbiomech.2010.11.015. Epub 2010 Dec 21. — View Citation

Rabelo ND, Lima B, Reis AC, Bley AS, Yi LC, Fukuda TY, Costa LO, Lucareli PR. Neuromuscular training and muscle strengthening in patients with patellofemoral pain syndrome: a protocol of randomized controlled trial. BMC Musculoskelet Disord. 2014 May 16;15:157. doi: 10.1186/1471-2474-15-157. — View Citation

Van Der Heijden RA, Lankhorst NE, Van Linschoten R, Bierma-Zeinstra SM, Van Middelkoop M. Exercise for treating patellofemoral pain syndrome: an abridged version of Cochrane systematic review. Eur J Phys Rehabil Med. 2016 Feb;52(1):110-33. Epub 2015 Jul 9 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain assessment assessed by using a visual analog scale, 10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation at baseline
Primary Pain assessment assessed by using a visual analog scale,10-cm VAS scale, with 0 indicating no pain and 10 for worst pain sensation after 12 weeks
Primary Muscle strength assessment assessed using a calibrated handheld dynamometer at baseline
Primary Muscle strength assessment assessed using a calibrated handheld dynamometer after 12 weeks
Secondary Functional status 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. at baseline
Secondary Functional status 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. after 12 weeks
Secondary health-related quality of life 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). at baseline
Secondary health-related quality of life 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). after 12 weeks
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