Patellofemoral Pain SyndromeNCT04011436

Therapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome

A study testing Strengthening program in people with Patellofemoral Pain Syndrome, run by Universidad Nacional de Colombia at 1 site in Colombia.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 15 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Patellofemoral Pain Syndrome
What is being tested?: Strengthening program
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteColombia
Study dates: 15 Aug 2018to 13 Apr 2019
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 15 to 40 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Patients with a clinical diagnosis of patellofemoral misalignment with knee CT, aged between 15 and 40 years.
Patients with clinical signs of retropatellar pain at rest or in the following activities: going up or down stairs, jumping, running, doing squats, kneeling, or sitting for a long time.
Pain or apprehension to the mobilization of the patella.
Crepitus with pain when performing squats.
Confirmatory CT of unilateral or bilateral patellofemoral misalignment.

Who cannot join

Clinical history or clinical evidence of patellofemoral dislocation, subluxation or osteoarthrosis of the knees.
Dysfunction of the ligaments, bursa, meniscus, patellar tendon or synovial plica of the knee.
Traumatic lesions of ligaments or meniscus or patients with osteoarthrosis secondary to congenital conditions.
Clinical history of orthopedic surgery in lower limbs.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Universidad Nacional de Colombia
Bogotá, 111321

Other trials in Colombia

About this study

Official title: Therapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome From Bogota, Colombia. Experimental Study, Clinical Controlled Trial

Introduction: The patellofemoral pain syndrome (SPF) is one of the most frequent pathologies generated by the knee joint. Conservative treatment with physiotherapy exercises reduces pain and improves functional capacity in the short and medium term. The purpose of this study was to evaluate the therapeutic effect of combining a program of muscle strengthening exercises for the core, hip and knee on anterior knee pain in non-athletic patients with SPF. Materials and methods: Randomized controlled trial clinical trial, designed to evaluate the effect of two muscle strengthening programs in people with SPF (Group A: exercises for core, hip and knee, Group B: exercises for hip and knee), during eight weeks of intervention in people between 15 and 40 years of age, with a clinical diagnosis of SPF, with a level of mild to moderate physical activity. The Kujala test was used to measure pain and quality of life.

Read the detailed description

Experimental study: controlled clinical trial, designed to evaluate the effect of two muscle strengthening programs in people with patellofemoral pain syndrome.

Young adults between 15 and 40 years old, with clinical diagnosis of patellofemoral pain syndrome (by means of Computerized Axial Tomography and medical concept of a specialist Orthopedist in knee), in the last three years, non-athletes with a level of physical activity between mild and moderate, affiliated to the health care institution CAFAM (Caja de Compensación Familiar is a compensation fund of Colombia that has pharmacies, hotels, Convention Center, Recreation Club, School, among others and offers Subsidy Services, Credits, Insurance, Tourism, Health, Education, Housing).

All the procedures developed within the study had as a reference the standards of good clinical practice and ethical principles for medical research in humans. The participants signed the informed consent where they accepted their participation in the present study.

The participants were randomized with the SNOSE (sequentially numbered, opaque sealed envelopes) method to two protocols of muscular strengthening (Group A: Exercises for core, hip and knee and Group B: Exercises for Hip and Knee).

Conditions: Patellofemoral Pain Syndrome
Being tested: Strengthening program
Keywords: anterior knee pain, patellofemoral pain syndrome AND treatment, patellofemoral pain AND diagnosis, patellofemoral pain syndrome AND exercise, patellofemoral pain AND physiotherapy
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.

Strengthening programOther
Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises

Study groups in NCT04011436
Study group	Role	What they receive
Core, Hip and knee.	Experimental	Physical Exercises to strengthen the core, hip and knee. Receives: Other: Strengthening program
Hip and Knee	Sham comparator	Physical Exercises to strengthen the hip and knee. Receives: Other: Strengthening program

What is being measured

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

Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
The Kujala patellofemoral pain scale, is an assessment tool developed to assesses pain and function in patients with disorders of the patellofemoral joint and consists of 13 questions, each with three to five response options, scored from 0 to 5, or 0 to 10, depending on the question. The lowest possible total value is 0 and corresponds to patients who are in a worse functional health condition. The highest possible total value is 100, for those that do not have any alteration and are in optimal condition. The results below, are presented as percentages and 95% confidence interval.
Measured: The next table shows the distribution of the 13 domains of the Kujala´Test by intervention group at baseline (Time point 1, one day before intervention). "Assessed at baseline and after treatment, only baseline pre-specified to be reported".
Assessment of Change in Pain With Visual Analogue Scale
Visual Analogue Scale (VAS) is a numeric scale from 0 to 10 to measure pain (been 0 no pain and 10 worse pain).
Measured: The pain assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)

Secondary outcomes (5)

Change in Patellofemoral Misalignment With Q Angle´s Exam
We measured the Q angle (degrees) between the border of the anterosuperior iliac spine, the center of the patella and the center of the tibia.
the data result, shows the median values, and the interquartile range (IR) with a Delta change between measure number 1 and number 2.
Measured: The Q angle assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention).
Change in Core Strength With McGill´s Exam
The protocol consists of 3 tests that measure all aspects of torso strength via isometric muscle endurance 1.Trunk flexor test, 2.Trunk extensor test 3. Lateral musculature test (rigth and left side). t is a timed test involving a static, isometric contraction, until the individual exhibits fatigue and can no longer hold the assumed position. The goal of the test is to hold each position for as long as possible.
Measured: The Core strength assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
Change in Quadriceps and Gluteus Strength With Squat´s Test
Squat Test is a field test, easy and simple to assess the Gluteus and quadriceps muscles strength.
Measured: Quadriceps and gluteus Strength assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
Change in Static Balance With Single Leg Stance
This test is used to evaluate the control of postural and static balance with the eyes open and closed in seconds. (if the participant does not complete the 45 seconds framework is thought to be lacking of equilibrium).
Measured: Static Balance assesment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
Change in the Total Amount (Work, Transport, Home and Recreation) of Physical Activity Reported in Minutes and Measured With The International Physical Activity Questionnaire-Long Form
The amount of physical activity places patients in 1 to 3 categories:
1. Low/inactive: do not meet criteria for categories 2 or 3. 2. Moderate: meet 1 the following: a. 3 or more days with at least 20 minutes of vigorous activity b. 5 or more days with at least 30 minutes of moderate-intensity activity or walking. c. 5 or more days with any combination of walking, moderate-intensity, or vigorous intensity activities with at least 600 MET-min/week. 3. High: meet 1 of the following: a. 3 or more days of vigorous-intensity activity and at least 1500 MET-min/week. b. 7 days of any combination of walking moderate-intensity, or vigorous intensity activities with at least 3000 MET-min/week.
We decided to add the time in minutes for each category of the IPAQ (work, transport, home and recreation), to obtain a more objective calculation, and to be able to make comparisons between the two different time points.
Measured: Physical Activity will be measured at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)

Timeline

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

15 Aug 201813 Apr 2019

First posted8 Jul 2019
Study start15 Aug 2018
Primary completion13 Jan 2019
Study completion13 Apr 2019

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
Model description: Experimental study type controlled clinical trial, designed to evaluate the effect of two muscle strengthening programs in people with patellofemoral pain syndrome (Group A: Exercises for core, hip and knee and Group B: exercises for hip and knee).
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04011436
Sponsor's protocol ID: Patellofemoral Pain Syndrome
Status last verified: Oct 2021
First submitted: 21 Jun 2019
Last updated: 23 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The investigators are not yet sure of sharing the IPD (individual participant data) of this study because they want to publish an article first and then decide.

Publications

Fulkerson JP. A Practical Guide to Understanding and Treating Patellofemoral Pain. Am J Orthop (Belle Mead NJ). 2017 Mar/Apr;46(2):101-103.
PubMed 28437495
Witvrouw E, Sneyers C, Lysens R, Victor J, Bellemans J. Reflex response times of vastus medialis oblique and vastus lateralis in normal subjects and in subjects with patellofemoral pain syndrome. J Orthop Sports Phys Ther. 1996 Sep;24(3):160-5. doi: 10.2519/jospt.1996.24.3.160.
PubMed 8866275
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.
PubMed 26158920
Selfe J, Janssen J, Callaghan M, Witvrouw E, Sutton C, Richards J, Stokes M, Martin D, Dixon J, Hogarth R, Baltzopoulos V, Ritchie E, Arden N, Dey P. Are there three main subgroups within the patellofemoral pain population? A detailed characterisation study of 127 patients to help develop targeted intervention (TIPPs). Br J Sports Med. 2016 Jul;50(14):873-80. doi: 10.1136/bjsports-2015-094792. Epub 2016 Feb 1.
PubMed 26834185
Grelsamer RP. Patellar nomenclature: the Tower of Babel revisited. Clin Orthop Relat Res. 2005 Jul;(436):60-5.
PubMed 15995421
Bloomer BA, Durall CJ. Does the Addition of Hip Strengthening to a Knee-Focused Exercise Program Improve Outcomes in Patients With Patellofemoral Pain Syndrome? J Sport Rehabil. 2015 Nov;24(4):428-33. doi: 10.1123/jsr.2014-0184. Epub 2014 Oct 29.
PubMed 25365356
De Blaiser C, Roosen P, Willems T, Danneels L, Bossche LV, De Ridder R. Is core stability a risk factor for lower extremity injuries in an athletic population? A systematic review. Phys Ther Sport. 2018 Mar;30:48-56. doi: 10.1016/j.ptsp.2017.08.076. Epub 2017 Aug 24.
PubMed 29246794

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?

See locations

Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)

All Patellofemoral Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Therapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome From Bogota, Colombia. Experimental Study, Clinical Controlled Trial
ClinicalTrials.gov ID: NCT04011436
Acronym / sponsor ID: Patellofemoral Pain Syndrome
Conditions: Patellofemoral Pain Syndrome
Keywords: anterior knee pain, patellofemoral pain syndrome AND treatment, patellofemoral pain AND diagnosis, patellofemoral pain syndrome AND exercise, patellofemoral pain AND physiotherapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Universidad Nacional de ColombiaUniversity, hospital or other
Study start: 15 Aug 2018 (actual)
Primary completion: 13 Jan 2019 (actual)
Study completion: 13 Apr 2019 (actual)
First posted: 8 Jul 2019 (actual)
Results: Posted 23 Nov 2021

Clinical summary

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

Detailed description

Experimental study: controlled clinical trial, designed to evaluate the effect of two muscle strengthening programs in people with patellofemoral pain syndrome.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Experimental study type controlled clinical trial, designed to evaluate the effect of two muscle strengthening programs in people with patellofemoral pain syndrome (Group A: Exercises for core, hip and knee and Group B: exercises for hip and knee).

Arm	Type	Receives
Core, Hip and knee.	Experimental	Other: Strengthening programPhysical Exercises to strengthen the core, hip and knee.
Hip and Knee	Sham comparator	Other: Strengthening programPhysical Exercises to strengthen the hip and knee.

Who may qualify

Ages: 15 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Patients with a clinical diagnosis of patellofemoral misalignment with knee CT, aged between 15 and 40 years.
Patients with clinical signs of retropatellar pain at rest or in the following activities: going up or down stairs, jumping, running, doing squats, kneeling, or sitting for a long time.
Pain or apprehension to the mobilization of the patella.
Crepitus with pain when performing squats.
Confirmatory CT of unilateral or bilateral patellofemoral misalignment.

Key exclusion criteria (4 listed)

Clinical history or clinical evidence of patellofemoral dislocation, subluxation or osteoarthrosis of the knees.
Dysfunction of the ligaments, bursa, meniscus, patellar tendon or synovial plica of the knee.
Traumatic lesions of ligaments or meniscus or patients with osteoarthrosis secondary to congenital conditions.
Clinical history of orthopedic surgery in lower limbs.

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
Strengthening programBoth protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention. Group A: 28 exercises Group B: 24 exercises	Other	Core, Hip and knee., Hip and Knee

Primary outcome

Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Time frame: The next table shows the distribution of the 13 domains of the Kujala´Test by intervention group at baseline (Time point 1, one day before intervention). "Assessed at baseline and after treatment, only baseline pre-specified to be reported".
The Kujala patellofemoral pain scale, is an assessment tool developed to assesses pain and function in patients with disorders of the patellofemoral joint and consists of 13 questions, each with three to five response options, scored from 0 to 5, or 0 to 10, depending on the question. The lowest possible total value is 0 and corresponds to patients who are in a worse functional health condition. The highest possible total value is 100, for those that do not have any alteration and are in optimal condition. The results below, are presented as percentages and 95% confidence interval.
Assessment of Change in Pain With Visual Analogue Scale
Time frame: The pain assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
Visual Analogue Scale (VAS) is a numeric scale from 0 to 10 to measure pain (been 0 no pain and 10 worse pain).

5 secondary outcomes

Change in Patellofemoral Misalignment With Q Angle´s Exam
Time frame: The Q angle assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention).
Change in Core Strength With McGill´s Exam
Time frame: The Core strength assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
Change in Quadriceps and Gluteus Strength With Squat´s Test
Time frame: Quadriceps and gluteus Strength assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
Change in Static Balance With Single Leg Stance
Time frame: Static Balance assesment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
Change in the Total Amount (Work, Transport, Home and Recreation) of Physical Activity Reported in Minutes and Measured With The International Physical Activity Questionnaire-Long Form
Time frame: Physical Activity will be measured at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)

Results and safety

Results posted to the registry on 23 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Core, Hip and Knee.	20	19
Hip and Knee	20	19

Primary outcome: Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.

Time frame: The next table shows the distribution of the 13 domains of the Kujala´Test by intervention group at baseline (Time point 1, one day before intervention). "Assessed at baseline and after treatment, only baseline pre-specified to be reported".. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Core, Hip and Knee. n = 20	Hip and Knee n = 20
Percentage of participants with constant and severe pain	20 (7.2 to 44.3)	20 (7.2 to 44.3)
Percentage of participants with occasional severe pain	20 (7.2 to 44.3)	40 (20.5 to 63.2)
Percentage of participants with pain that interferes with sleep	10 (2.31 to 34.2)	10 (2.31 to 34.2)
Percentage of participants with mild and occasional pain	50 (28.3 to 71.6)	30 (13.4 to 54.1)
Percentage of participants with permanent inflammation	10 (2.31 to 34.2)	20 (7.2 to 44.3)
Percentage of participants with inflammation every night	15 (4.5 to 39.2)	0 (0 to 0)
Percentage of participants with inflammation with daily activities	30 (13.4 to 54.1)	10 (2.31 to 34.2)
Percentage of participants with inflammation after a great effort	30 (13.4 to 54.1)	30 (13.4 to 54.1)

Core, Hip and Knee. vs Hip and Knee: difference in frequency distribution: 0.05 (95% CI 0.025 to 0.05), p <0.05, Fisher Exact

Population analysed: Group A (core, hip and knee) completed a 28 exercises and Group B (hip and knee) completed a 24 exercises both groups during 8 weeks, each exercise session lasted 45 to 60 minutes and included warm up, strengthening, balance and stretching.

Primary outcome: Assessment of Change in Pain With Visual Analogue Scale

Time frame: The pain assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention). Median (Inter-Quartile Range). Unit: units on a scale

Measure	Core, Hip and Knee. n = 20	Hip and Knee n = 20
Initial VAS	7.5 (5.5 to 9.0)	7 (5.5 to 8.5)
Final VAS	2.0 (0 to 2.0)	2.0 (0 to 4.0)
Delta (Change between Initial and Final VAS)	-6.0 (-10.0 to -4.0)	-4.0 (-7.0 to -3.0)

Core, Hip and Knee. vs Hip and Knee: Median Difference (Final Values): 0.058, p <0.05, Wilcoxon (Mann-Whitney)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, about 8 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Core, Hip and Knee.	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Hip and Knee	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28437495Fulkerson JP. A Practical Guide to Understanding and Treating Patellofemoral Pain. Am J Orthop (Belle Mead NJ). 2017 Mar/Apr;46(2):101-103.
Background: PubMed 8866275Witvrouw E, Sneyers C, Lysens R, Victor J, Bellemans J. Reflex response times of vastus medialis oblique and vastus lateralis in normal subjects and in subjects with patellofemoral pain syndrome. J Orthop Sports Phys Ther. 1996 Sep;24(3):160-5. doi: 10.2519/jospt.1996.24.3.160.
Background: PubMed 26158920Van 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.
Background: PubMed 26834185Selfe J, Janssen J, Callaghan M, Witvrouw E, Sutton C, Richards J, Stokes M, Martin D, Dixon J, Hogarth R, Baltzopoulos V, Ritchie E, Arden N, Dey P. Are there three main subgroups within the patellofemoral pain population? A detailed characterisation study of 127 patients to help develop targeted intervention (TIPPs). Br J Sports Med. 2016 Jul;50(14):873-80. doi: 10.1136/bjsports-2015-094792. Epub 2016 Feb 1.
Background: PubMed 15995421Grelsamer RP. Patellar nomenclature: the Tower of Babel revisited. Clin Orthop Relat Res. 2005 Jul;(436):60-5.
Background: PubMed 25365356Bloomer BA, Durall CJ. Does the Addition of Hip Strengthening to a Knee-Focused Exercise Program Improve Outcomes in Patients With Patellofemoral Pain Syndrome? J Sport Rehabil. 2015 Nov;24(4):428-33. doi: 10.1123/jsr.2014-0184. Epub 2014 Oct 29.
Background: PubMed 29246794De Blaiser C, Roosen P, Willems T, Danneels L, Bossche LV, De Ridder R. Is core stability a risk factor for lower extremity injuries in an athletic population? A systematic review. Phys Ther Sport. 2018 Mar;30:48-56. doi: 10.1016/j.ptsp.2017.08.076. Epub 2017 Aug 24.
Individual participant dataSharing planned: No. The investigators are not yet sure of sharing the IPD (individual participant data) of this study because they want to publish an article first and then decide.

Related trials for Patellofemoral Pain Syndrome

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Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
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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.

Juan Alzate Granados study chair

Universidad Nacional de Colombia

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

Questions about this trial

What is this clinical trial studying?

A study testing Strengthening program in people with Patellofemoral Pain Syndrome, run by Universidad Nacional de Colombia at 1 site in Colombia.

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 5 inclusion and 4 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 23 Nov 2021. 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 Colombia. 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. Some participants in this study may receive a placebo. 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 23 Nov 2021). 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?

Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval. (time frame: The next table shows the distribution of the 13 domains of the Kujala´Test by intervention group at baseline (Time point 1, one day before intervention). "Assessed at baseline and after treatment, only baseline pre-specified to be reported".). The study lists 2 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 NCT04011436, 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 23 Nov 2021.