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

NCT03042559 | Completed Results FDA Device

• 1 other identifier: 5160417
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (16)

• Anterior Pelvic Tilt

  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. Normative values from other study that we will be using to compare anterior pelvic tilt: Male = 9° and Female = 12° (from Nguyen study in 2007). The CHEK inclinometer caliper has two arms; one arm will be placed on ASIS (front of pelvis) while the other on the PSIS (back of pelvis). The angle of the caliper will be determined to record the degree of anterior pelvic tilt. Baseline measurement to Post-intervention measurement = Four (4) weeks.

  Baseline to Post intervention

• Anterior Pelvic Tilt

  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.

  2 weeks

• Anterior Pelvic Tilt

  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.

  4 weeks

• Numeric Pain Rating Scale (NPRS)

  The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  baseline

• Numeric Pain Rating Scale (NPRS)

  Used to assess pain level throughout the intervention. Scale: 0-10. Scoring: 0 (no pain) to 10 (worst, imaginable pain).

  Immediately following 1st session

• Numeric Pain Rating Scale (NPRS)

  The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  2 weeks

• Numeric Pain Rating Scale (NPRS)

  Used to assess pain level throughout the intervention. Scale: 0-10. Scoring: 0 (no pain) to 10 (worst, imaginable pain).

  4 weeks

• Global Rating of Change (GROC)

  GROC scales offer a flexible, quick, and simple method of charting self-assessed clinical progress in research and clinical settings. 15-Point: Scale -7 to 0 to +7. A score of 0 = No change, +1 to +3 = small positive change, +4 to +5 = Moderate positive change, +6 to +7 = Large positive change. All negative scores (minus numbers) represent a poor outcome (-7 being the worst possible outcome).

  Immediately following 1st session

• Global Rating of Change (GROC)

  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.

  2 weeks

• Global Rating of Change (GROC)

  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.

  4 weeks

• Kujala Score

  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. A score close to 0 represents a low level of function. 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.

  baseline

• Kujala Score

  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.

  4 weeks

• Lateral Step-Down Test

  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. Subjects will be asked to report a verbal pain score during the step-up test at each test session. 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).

  baseline

• Lateral Step-Down Test

  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. Subjects will be asked to report a verbal pain score during the step-up test at each test session. 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).

  Immediately following 1st session

• Lateral Step-Down Test

  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).

  2 weeks

• Lateral Step-Down Test

  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).

  4 weeks

Secondary Outcomes (12)

• Iliotibial Band Flexibility

  baseline

• Iliotibial Band Flexibility

  Immediately following 1st session

• Iliotibial Band Flexibility

  2 weeks

• Iliotibial Band Flexibility

  4 weeks

• Hip Internal Rotation ROM

  baseline

Study Arms (2)

Protonics knee brace

ACTIVE COMPARATOR

All subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion.

Device: Protonics Knee brace

Sport cords

EXPERIMENTAL

Resistive sports cord to resist knee flexion.

Device: Sports Cords

Interventions

Protonics Knee brace DEVICE

The Protonics system has been introduced to physical therapists as a potential treatment for PFPS. The system includes a brace set to resist knee flexion and a set of specific exercises to perform daily. Through resistance to knee flexion, the system is advertised to decrease retropatellar contact pressure due to changes in pelvis inclination and available hip rotation. Specifically, resistance to knee flexion is purported to increase hamstring activity and inhibit the activity of the tensor fasciae latae and psoas muscles. The manufacturer asserts that prolonged use of the system results in greater hamstring activation, which leads to permanent structural changes through reciprocal inhibition at the hip and pelvis. The warm-up consisted of the subject wearing the ProtonicsTM knee brace set at a moderate resistance level and flexing the knees while sitting, standing, and reclining in the supine and prone positions.

Protonics knee brace

Sports Cords DEVICE

Subjects assigned to the sport cord group were asked to do the same warm-ups and exercises using the sport cord in the supine, standing, sitting, and prone positions. prone. The only difference is that subjects were asked to only walk backwards instead of forwards in order to avoid activation of the hip flexor muscle. The appropriate level of resistance for each subject was calculated by multiplying their weight in pounds by 0.3. Subjects were then given either light, medium, or heavy resistance cords according to the following classification scheme: light (pink color) with resistance 3 (R3), 0-30 lbs.; medium (orange color) with resistance 5 (R5) 0-50 lbs.; heavy (yellow color) with resistance 7 (R7) 0-70 lbs. All subjects completed three study visits, and a total of four measurements were taken at baseline, immediately following the first session, at two weeks, and at 4 weeks.

Sport cords

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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."

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Related Publications (7)

• 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.

  PMID: 9079175 RESULT

• 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.

  PMID: 8231783 RESULT

• 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.

  PMID: 22513943 RESULT

• 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.

  PMID: 24725788 RESULT

• 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.

  PMID: 15901122 RESULT

• 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.

  PMID: 15085211 RESULT

• 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.

  PMID: 12527250 RESULT

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Limitations and Caveats

The intervention protocol was only four weeks, which is a short time period, and it is possible that with a longer study duration, differences between the intervention groups may have become more evident.

Results Point of Contact

• Title: Dr. Everett Lohman III
• Organization: Loma Linda University

elohman@llu.edu

9095584632

Study Officials

• Everett Lohman, Dsc

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 3, 2017
• Study Start: February 14, 2017
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: May 15, 2020
• Results First Posted: November 22, 2019

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)