Patellofemoral Pain SyndromeHRENCT03042559

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

A study testing Protonics Knee brace and Sports Cords in people with Patellofemoral Pain Syndrome, run by Loma Linda University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Patellofemoral Pain Syndrome
What is being tested?: Protonics Knee brace and Sports Cords
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2017to 8 Jan 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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."

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda University Health
Loma Linda, California, 92354

Other trials in United States

About this study

Official title: The Effects of Protonics Knee Brace Versus Hamstring Resisted Exercise on Individuals With Patellofemoral Pain Syndrome

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.

Read the 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.

Conditions: Patellofemoral Pain Syndrome
Being tested: Protonics Knee brace, Sports Cords
Medical subject headings: Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Protonics Knee braceDevice
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.
Sports CordsDevice
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.

Study groups in NCT03042559
Study group	Role	What they receive
Protonics knee brace	Active comparator	All subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion. Receives: Device: Protonics Knee brace
Sport cords	Experimental	Resistive sports cord to resist knee flexion. Receives: Device: Sports Cords

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 4 weeks

Secondary outcomes (12)

Iliotibial Band Flexibility
To assess the flexibility of iliotibial band
Measured: baseline
Iliotibial Band Flexibility
To assess the flexibility of iliotibial band
Measured: Immediately following 1st session
Iliotibial Band Flexibility
To assess the flexibility of iliotibial band
Measured: 2 weeks
Iliotibial Band Flexibility
To assess the flexibility of iliotibial band
Measured: 4 weeks
Hip Internal Rotation ROM
To measure the internal rotation of hip in sitting natural position with hip and knee on 90 degree flexion
Measured: baseline
Hip Internal Rotation ROM
To measure the internal rotation of hip in sitting natural position with hip and knee on 90 degree flexion
Measured: Immediately following 1st session
Hip Internal Rotation ROM
To measure the internal rotation of hip in sitting natural position with hip and knee on 90 degree flexion
Measured: 2 weeks
Hip Internal Rotation ROM
To measure the internal rotation of hip in sitting natural position with hip and knee on 90 degree flexion
Measured: 4 weeks
Hip External Rotation ROM
To measure the External rotation of hip in sitting natural position with hip and knee on 90 degree flexion
Measured: baseline
Hip External Rotation ROM
To measure the External rotation of hip in sitting natural position with hip and knee on 90 degree flexion
Measured: Immediately following 1st session
Hip External Rotation ROM
To measure the external rotation of hip in sitting natural position with hip and knee on 90 degree flexion
Measured: 2 weeks
Hip External Rotation ROM
To measure the external rotation of hip in sitting natural position with hip and knee on 90 degree flexion
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20178 Jan 2018

First posted3 Feb 2017 (estimated)
Study start14 Feb 2017
Primary completion8 Jan 2018
Study completion8 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03042559
Sponsor's protocol ID: 5160417
Acronym: HRE
Status last verified: Apr 2020
First submitted: 30 Jan 2017
Last updated: 15 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 9079175
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.
PubMed 8231783
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.
PubMed 22513943
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.
PubMed 24725788
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.
PubMed 15901122
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.
PubMed 15085211
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.
PubMed 12527250

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Patellofemoral Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Protonics Knee Brace Versus Hamstring Resisted Exercise on Individuals With Patellofemoral Pain Syndrome
ClinicalTrials.gov ID: NCT03042559
Acronym / sponsor ID: HRE / 5160417
Conditions: Patellofemoral Pain Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: 14 Feb 2017 (actual)
Primary completion: 8 Jan 2018 (actual)
Study completion: 8 Jan 2018 (actual)
First posted: 3 Feb 2017 (estimated)
Results: Posted 22 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Protonics knee brace	Active comparator	Device: Protonics Knee braceAll subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion.
Sport cords	Experimental	Device: Sports CordsResistive sports cord to resist knee flexion.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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."

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Protonics Knee braceThe 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.	Device	Protonics knee brace
Sports CordsSubjects 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.	Device	Sport cords

Primary outcome

Anterior Pelvic Tilt
Time frame: Baseline to Post intervention
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.
Anterior Pelvic Tilt
Time frame: 2 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.
Anterior Pelvic Tilt
Time frame: 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)
Time frame: baseline
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).
Numeric Pain Rating Scale (NPRS)
Time frame: Immediately following 1st session
Used to assess pain level throughout the intervention. Scale: 0-10. Scoring: 0 (no pain) to 10 (worst, imaginable pain).
Numeric Pain Rating Scale (NPRS)
Time frame: 2 weeks
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).
Numeric Pain Rating Scale (NPRS)
Time frame: 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)
Time frame: Immediately following 1st session
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).
Global Rating of Change (GROC)
Time frame: 2 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.
Global Rating of Change (GROC)
Time frame: 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
Time frame: baseline
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.
Kujala Score
Time frame: 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
Time frame: baseline
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).
Lateral Step-Down Test
Time frame: Immediately following 1st session
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).
Lateral Step-Down Test
Time frame: 2 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).
Lateral Step-Down Test
Time frame: 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).

12 secondary outcomes

Iliotibial Band Flexibility
Time frame: baseline
Iliotibial Band Flexibility
Time frame: Immediately following 1st session
Iliotibial Band Flexibility
Time frame: 2 weeks
Iliotibial Band Flexibility
Time frame: 4 weeks
Hip Internal Rotation ROM
Time frame: baseline
Hip Internal Rotation ROM
Time frame: Immediately following 1st session
Hip Internal Rotation ROM
Time frame: 2 weeks
Hip Internal Rotation ROM
Time frame: 4 weeks
Hip External Rotation ROM
Time frame: baseline
Hip External Rotation ROM
Time frame: Immediately following 1st session
Hip External Rotation ROM
Time frame: 2 weeks
Hip External Rotation ROM
Time frame: 4 weeks

Results and safety

Results posted to the registry on 22 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Protonics Knee Brace	22	21
Sport Cords	21	20

Primary outcome: Anterior Pelvic Tilt

Time frame: Baseline to Post intervention. Mean (Standard Deviation). Unit: degree

Measure	Protonics Knee Brace n = 21	Sport Cords n = 20
Value	5 (2.8)	3.2 (2.8)

Protonics Knee Brace vs Sport Cords: Wilcoxon (Mann-Whitney)

Primary outcome: Anterior Pelvic Tilt

Time frame: 2 weeks. Mean (Standard Deviation). Unit: degree

Measure	Protonics Knee Brace n = 21	Sport Cords n = 20
Value	3.1 (2)	2.5 (2)

Primary outcome: Anterior Pelvic Tilt

Time frame: 4 weeks. Mean (Standard Deviation). Unit: degree

Measure	Protonics Knee Brace n = 21	Sport Cords n = 20
Value	2 (1.6)	1.9 (1.6)

Primary outcome: Numeric Pain Rating Scale (NPRS)

Time frame: baseline. Mean (Standard Deviation). Unit: cm

Measure	Protonics Knee Brace n = 21	Sport Cords n = 20
Value	4.5 (1.2)	3.8 (1.9)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study has concluded. During the entire 4-week experiment (baseline to conclusion), no adverse event (AEs) occurred to any of the subjects. Subjects participated in one of two exercise programs over a 4 week period from baseline testing to the conclusion of the study. In each group, exercises were to be performed 3 times per week. This represents a total 12 exercise sessions (3 x 4 WEEKS ). Each session included 3 sets of 10-15 repetitions for each exercise as outlined.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Protonics Knee Brace	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Sport Cords	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 9079175Arroll 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.
Results publication: PubMed 8231783Bockrath 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.
Results publication: PubMed 22513943Callaghan 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.
Results publication: PubMed 24725788Azevedo 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.
Results publication: PubMed 15901122Denton 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.
Results publication: PubMed 15085211Earl 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.
Results publication: PubMed 12527250Gajdosik 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Everett Lohman, Dsc principal investigator

Loma Linda University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Protonics Knee brace and Sports Cords in people with Patellofemoral Pain Syndrome, run by Loma Linda University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anterior Pelvic Tilt (time frame: Baseline to Post intervention). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03042559, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.