Clinical trial NCT03042559: Protonics Knee Brace Versus Hamstring Resisted Exercise (HRE) on Individuals With Patellofemoral Pain Syndrome
Official title: The Effects of Protonics Knee Brace Versus Hamstring Resisted Exercise on Individuals With Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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."

Primary outcomes:
measure: Anterior Pelvic Tilt
timeFrame: Baseline to Post intervention
measure: Anterior Pelvic Tilt
timeFrame: 2 weeks
measure: Anterior Pelvic Tilt
timeFrame: 4 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: baseline
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Immediately following 1st session
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 2 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 4 weeks
measure: Global Rating of Change (GROC)
timeFrame: Immediately following 1st session
measure: Global Rating of Change (GROC)
timeFrame: 2 weeks
measure: Global Rating of Change (GROC)
timeFrame: 4 weeks
measure: Kujala Score
timeFrame: baseline
measure: Kujala Score
timeFrame: 4 weeks
measure: Lateral Step-Down Test
timeFrame: baseline
measure: Lateral Step-Down Test
timeFrame: Immediately following 1st session
measure: Lateral Step-Down Test
timeFrame: 2 weeks
measure: Lateral Step-Down Test
timeFrame: 4 weeks
Secondary outcomes:
measure: Iliotibial Band Flexibility
timeFrame: baseline
measure: Iliotibial Band Flexibility
timeFrame: Immediately following 1st session
measure: Iliotibial Band Flexibility
timeFrame: 2 weeks
measure: Iliotibial Band Flexibility
timeFrame: 4 weeks
measure: Hip Internal Rotation ROM
timeFrame: baseline
measure: Hip Internal Rotation ROM
timeFrame: Immediately following 1st session
measure: Hip Internal Rotation ROM
timeFrame: 2 weeks
measure: Hip Internal Rotation ROM
timeFrame: 4 weeks
measure: Hip External Rotation ROM
timeFrame: baseline
measure: Hip External Rotation ROM
timeFrame: Immediately following 1st session
measure: Hip External Rotation ROM
timeFrame: 2 weeks
measure: Hip External Rotation ROM
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University
name: Everett Lohman, Dsc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arroll B, Ellis-Pegler E, Edwards A, Sutcliffe G. Patellofemoral pain syndrome. A critical review of the clinical trials on nonoperative therapy. Am J Sports Med. 1997 Mar-Apr;25(2):207-12. doi: 10.1177/036354659702500212.
citation: Bockrath K, Wooden C, Worrell T, Ingersoll CD, Farr J. Effects of patella taping on patella position and perceived pain. Med Sci Sports Exerc. 1993 Sep;25(9):989-92.
citation: Callaghan MJ, Selfe J. Patellar taping for patellofemoral pain syndrome in adults. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD006717. doi: 10.1002/14651858.CD006717.pub2.
citation: Azevedo DC, Santos H, Carneiro RL, Andrade GT. Reliability of sagittal pelvic position assessments in standing, sitting and during hip flexion using palpation meter. J Bodyw Mov Ther. 2014 Apr;18(2):210-4. doi: 10.1016/j.jbmt.2013.05.017. Epub 2013 Jun 17.
citation: Denton J, Willson JD, Ballantyne BT, Davis IS. The addition of the Protonics brace system to a rehabilitation protocol to address patellofemoral joint syndrome. J Orthop Sports Phys Ther. 2005 Apr;35(4):210-9. doi: 10.2519/jospt.2005.35.4.210.
citation: Earl JE, Piazza SJ, Hertel J. The Protonics Knee Brace Unloads the Quadriceps Muscles in Healthy Subjects. J Athl Train. 2004 Mar;39(1):44-49.
citation: Gajdosik RL, Sandler MM, Marr HL. Influence of knee positions and gender on the Ober test for length of the iliotibial band. Clin Biomech (Bristol). 2003 Jan;18(1):77-9. doi: 10.1016/s0268-0033(02)00168-7.