Protonics Knee Brace Versus Hamstring Resisted Exercise (HRE) on Individuals With Patellofemoral Pain Syndrome

Not Applicable

Completed

Conditions: Patellofemoral Pain Syndrome

Interventions: Device: Protonics Knee brace
Device: Sports Cords

Registration Number: NCT03042559

Lead Sponsor: Loma Linda University

Brief Summary: ProtonicsTM Knee brace has been suggested as an intervention for patients with patellofemoral pain syndrome (PFPS). However, the effectiveness of this knee brace compared to traditional conservative methods knee rehabilitation is lacking. The objective of this randomized controlled trial was to compare the effect of ProtonicsTM knee brace vs. sports cord on knee pain and function in patients with PFPS.

Detailed Description: The purpose of this graduate student research study was to compare the effect of ProtonicsTM knee brace vs. sports cord on knee pain and function in patients with PFPS.

Design: Randomized controlled trial.

Setting: Loma Linda University.

Participants: Subjects with patellofemoral pain will participate in the study.

Intervention: Subjects will be randomized to one of two treatment groups, the ProtonicsTM knee brace or the sport cord to complete a series of resistance exercises over the course of 4 weeks.

Main Outcome Measures: Both groups will be evaluated according to the following clinical outcomes: Anterior pelvic tilt (APT), hip internal/external rotation, and iliotibial band flexibility. The following functional outcomes were also assessed: Global Rating of Change (GROC) scale, the Kujala score, the Numeric Pain Rating Scale, and the lateral step-down test.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

Inclusion Criteria

Subjects will be males and females who have Patellofemoral pain symptoms for more than 1 month, have pain level ≥ 3 on a Numeric Pain Rating Scale, and pain during at least 2 activities, such as squatting, ascending/descending stairs, and/or running.

Exclusion Criteria

Subjects will be excluded if they have previous traumatic injuries to the knee joint/lower limbs, sign, and symptoms of meniscus tear or ligamentous-related pathology, neurological disorders and being on pain medication."

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protonics knee brace	Protonics Knee brace	All subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion.
Sport cords	Sports Cords	Resistive sports cord to resist knee flexion.

Primary Outcome Measures

Name	Time	Method
Anterior Pelvic Tilt	4 weeks	Anterior Pelvic Tilt: tilting of the pelvic will be measured with CHEK inclinometer. Tilting will be measured while subjects are in a standing position. The examiner will determine the two measure line marks, anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) to find the oblique angle of the pelvic. Approximate normally anterior pelvic tilt for male is 9° and for female is about 12° (Nguyen, 2007). The caliper has two arms; one arm will be placed on ASIP while the other on the PSIS. The angle of the caliper will be determined to record the degree of anterior pelvic tilt.
Numeric Pain Rating Scale (NPRS)	4 weeks	Used to assess pain level throughout the intervention. Scale: 0-10. Scoring: 0 (no pain) to 10 (worst, imaginable pain).
Global Rating of Change (GROC)	4 weeks	GRC scales offer a flexible, quick, and simple method of charting self-assessed clinical progress in research and clinical settings. It ranges from -7 to 7, in which item -7 represent very great deal worse, 0 represent no change in progress, and 7 exemplify a very great better.
Kujala Score	4 weeks	A self-report questionnaire, which is used to evaluate subjective symptoms and functional limitations in subjects with PFPS with a score range between of 0 - 100 based on pain associated with variety of functional activities such as prolonged sitting, squatting, running, and jumping. A score close to 100 indicates a higher functional performance. Kujala scale has shown acceptable test-retest reliability (rho = 0.86) (Paxon et al, 2003). Kujala scale scores will be documented at the beginning and end of the intervention program.
Lateral Step-Down Test	4 weeks	Lateral step test: is a quick and simple practical clinical measure of functional. Subjects with PFPS will be asked to step up and down on a 15-cm step for 15 seconds each with a cadence of 2 steps per second. The total number of step-ups during this time will be recorded. This test will be performed every two weeks to document any improvement in the functional performance. The test has shown to be reliable and valid, with test-retest reliability of (ICC = 0.90) (Ross et al, 1997).

Secondary Outcome Measures

Name	Time	Method
Hip Internal Rotation ROM	4 weeks	To measure the internal rotation of hip in sitting natural position with hip and knee on 90 degree flexion
Iliotibial Band Flexibility	4 weeks	To assess the flexibility of iliotibial band
Hip External Rotation ROM	4 weeks	To measure the external rotation of hip in sitting natural position with hip and knee on 90 degree flexion