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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04011436
Enrollment
40
Registered
2019-07-08
Start date
2018-08-15
Completion date
2019-04-13
Last updated
2021-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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.

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).

Interventions

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

Sponsors

Universidad Nacional de Colombia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

SNOSE: Sequentially Numbered, Opaque Sealed Envelopes. The forty subjects of the experimental procedure were assigned to the two intervention groups from three steps: 1. A paper / charcoal sheet was placed on an Assignation paper marked with Group A or Group B, 2. Then they were lined with aluminum foil, also rectangular and 3. They were finally inserted in a white envelope which was sealed with glue. Forty of these envelopes were made, twenty for Group A and the other half for Group B, after that, they were mixed in a cardboard box and then enumerated one by one at random until the 40 envelopes were completed. Each envelope was delivered in order of numbering to each of the patients who were entering the treatment. The investigator directed the strengthening program and another Physical Therapist addressed the tests.

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in Quadriceps and Gluteus Strength With Squat´s TestQuadriceps 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)Squat Test is a field test, easy and simple to assess the Gluteus and quadriceps muscles strength.
Change in Patellofemoral Misalignment With Q Angle´s ExamThe 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).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.
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 FormPhysical 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)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.
Change in Static Balance With Single Leg StanceStatic 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)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).
Change in Core Strength With McGill´s ExamThe 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)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.

Countries

Colombia

Participant flow

Participants by arm

ArmCount
Core, Hip and Knee.
Physical Exercises to strengthen the core, hip and knee. Strengthening program: 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
20
Hip and Knee
Physical Exercises to strengthen the hip and knee. Strengthening program: 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
20
Total40

Baseline characteristics

CharacteristicHip and KneeCore, Hip and Knee.Total
Age, Categorical
Age
<=18 years
2 Participants2 Participants4 Participants
Age, Categorical
Age
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Age
Between 18 and 65 years
18 Participants18 Participants36 Participants
Age, Continuous29 years32.5 years30.75 years
BMI23.8 kg/m^225.4 kg/m^224.6 kg/m^2
Fat Percent35.4 percent35.4 percent35.4 percent
Height159.5 cm160 cm159.75 cm
Muscle Percent26.2 percent26.9 percent26.6 percent
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Colombia
20 Participants20 Participants40 Participants
Sex: Female, Male
Female
18 Participants18 Participants36 Participants
Sex: Female, Male
Male
2 Participants2 Participants4 Participants
The International Physical Activity Questionnaire, Long Form (27-item self-reported measure)1617 total minutes of physical activity3003 total minutes of physical activity2310 total minutes of physical activity
Visceral Fat Percent5 percent6 percent5.5 percent

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 20
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

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.

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.

Population: 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.

ArmMeasureGroupValue (NUMBER)
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with constant and severe pain20 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with occasional severe pain20 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain that interferes with sleep10 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with mild and occasional pain50 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with permanent inflammation10 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with inflammation every night15 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with inflammation with daily activities30 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with inflammation after a great effort30 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with not inflammation15 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with severe atrophy0 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with mild atrophy15 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with not atrophy85 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with lameness constantly10 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with lameness a little, sometimes80 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with no limp10 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with impossible to support the limb10 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain with limb support55 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with the extremity completely painless35 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can't walk5 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can walk between 1-2 Km20 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can walk more than 2 km45 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can walk without limit30 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that are not able to go up and down stairs5 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain when going up and down the stairs50 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with slight pain when going down the stairs45 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can go up and down the stairs without difficulty0 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can't do squats20 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can do squats with help5 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that are always in pain when doing squats20 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain when doing squats quickly25 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants squating without difficulty30 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants unable to remain seated with knees bent15 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain forces him/her to extend his knees65 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that are always in pain to sit with their knees bent10 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with only pain if they have exercised5 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with no problem sitting with their knees bent5 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with more than two dislocations of the patella10 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with less than a confirmed dislocation10 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with dislocations occasionally with daily activities20 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with dislocations occasionally with exercise30 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with no dislocations of the patella30 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with severe deficiency for knee flexion20 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with mild deficiency for knee flexion70 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with no deficiency for knee flexion10 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants unable to run25 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with severe pain always when running0 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with slight pain since starting to run25 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain after 2 km of running35 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can run without limit15 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants unable to jump25 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with permanent pain when jumping15 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with slight difficulty jumping35 percentage of participants
Core, Hip and Knee.Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with no difficulty jumping25 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can't do squats0 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with constant and severe pain20 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with slight pain since starting to run25 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with occasional severe pain40 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can do squats with help15 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain that interferes with sleep10 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with no dislocations of the patella5 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with mild and occasional pain30 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that are always in pain when doing squats40 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with permanent inflammation20 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with slight difficulty jumping35 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with inflammation every night0 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain when doing squats quickly40 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with inflammation with daily activities10 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with severe deficiency for knee flexion5 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with inflammation after a great effort30 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants squating without difficulty5 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with not inflammation40 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain after 2 km of running35 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with severe atrophy5 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants unable to remain seated with knees bent0 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with mild atrophy30 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with mild deficiency for knee flexion70 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with not atrophy70 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain forces him/her to extend his knees70 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with lameness constantly10 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with permanent pain when jumping20 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with lameness a little, sometimes75 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that are always in pain to sit with their knees bent10 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with no limp15 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with no deficiency for knee flexion25 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with impossible to support the limb5 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with only pain if they have exercised20 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain with limb support80 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can run without limit10 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with the extremity completely painless15 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with no problem sitting with their knees bent0 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can't walk5 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants unable to run15 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can walk between 1-2 Km25 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with more than two dislocations of the patella10 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can walk more than 2 km45 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with no difficulty jumping15 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can walk without limit25 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with less than a confirmed dislocation15 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that are not able to go up and down stairs0 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with severe pain always when running15 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with pain when going up and down the stairs75 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with dislocations occasionally with daily activities40 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with slight pain when going down the stairs15 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants unable to jump30 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants that can go up and down the stairs without difficulty10 percentage of participants
Hip and KneeAssessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.Percentage of participants with dislocations occasionally with exercise30 percentage of participants
p-value: <0.0595% CI: [0.025, 0.05]Fisher Exact
Primary

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).

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)

ArmMeasureGroupValue (MEDIAN)
Core, Hip and Knee.Assessment of Change in Pain With Visual Analogue ScaleInitial VAS7.5 units on a scale
Core, Hip and Knee.Assessment of Change in Pain With Visual Analogue ScaleFinal VAS2.0 units on a scale
Core, Hip and Knee.Assessment of Change in Pain With Visual Analogue ScaleDelta (Change between Initial and Final VAS)-6.0 units on a scale
Hip and KneeAssessment of Change in Pain With Visual Analogue ScaleInitial VAS7 units on a scale
Hip and KneeAssessment of Change in Pain With Visual Analogue ScaleFinal VAS2.0 units on a scale
Hip and KneeAssessment of Change in Pain With Visual Analogue ScaleDelta (Change between Initial and Final VAS)-4.0 units on a scale
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary

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.

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)

ArmMeasureGroupValue (MEDIAN)
Core, Hip and Knee.Change in Core Strength With McGill´s ExamPlank (Time Point 1)20.5 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamPlank (Time Point 2)60 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamPlank: Delta or change between Time point 1 and 237 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamLateral Plank (Right) (Time Point 1)15 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamLateral Plank (Right) (Time Point 2)45 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamRigth Lateral Plank: Delta or change between Time point 1 and 230 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamLateral Plank (Left) (Time Point 1)12.5 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamLateral Plank (Left) (Time Point 2)45 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamLeft Lateral Plank: Delta or change between Time point 1 and 230 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamTrunk Extension (Time Point 1)13.5 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamTrunk Extension (Time Point 2)61 seconds
Core, Hip and Knee.Change in Core Strength With McGill´s ExamTrunk Extension: Delta or change between Time point 1 and 249 seconds
Hip and KneeChange in Core Strength With McGill´s ExamTrunk Extension (Time Point 2)30 seconds
Hip and KneeChange in Core Strength With McGill´s ExamPlank (Time Point 1)30 seconds
Hip and KneeChange in Core Strength With McGill´s ExamLateral Plank (Left) (Time Point 1)18 seconds
Hip and KneeChange in Core Strength With McGill´s ExamPlank (Time Point 2)35 seconds
Hip and KneeChange in Core Strength With McGill´s ExamTrunk Extension (Time Point 1)13.5 seconds
Hip and KneeChange in Core Strength With McGill´s ExamPlank: Delta or change between Time point 1 and 210 seconds
Hip and KneeChange in Core Strength With McGill´s ExamLateral Plank (Left) (Time Point 2)21 seconds
Hip and KneeChange in Core Strength With McGill´s ExamLateral Plank (Right) (Time Point 1)15 seconds
Hip and KneeChange in Core Strength With McGill´s ExamTrunk Extension: Delta or change between Time point 1 and 215 seconds
Hip and KneeChange in Core Strength With McGill´s ExamLateral Plank (Right) (Time Point 2)22 seconds
Hip and KneeChange in Core Strength With McGill´s ExamLeft Lateral Plank: Delta or change between Time point 1 and 25 seconds
Hip and KneeChange in Core Strength With McGill´s ExamRigth Lateral Plank: Delta or change between Time point 1 and 26 seconds
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary

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.

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).

ArmMeasureGroupValue (MEDIAN)
Core, Hip and Knee.Change in Patellofemoral Misalignment With Q Angle´s ExamDelta or change between Time point 1 and 20 Degrees
Core, Hip and Knee.Change in Patellofemoral Misalignment With Q Angle´s ExamInitial Rigth Knee19 Degrees
Core, Hip and Knee.Change in Patellofemoral Misalignment With Q Angle´s ExamFinal Rigth Knee18 Degrees
Core, Hip and Knee.Change in Patellofemoral Misalignment With Q Angle´s ExamInitial Left Knee18 Degrees
Core, Hip and Knee.Change in Patellofemoral Misalignment With Q Angle´s ExamFinal Left Knee18 Degrees
Core, Hip and Knee.Change in Patellofemoral Misalignment With Q Angle´s ExamDelta or Change between Time point 1 and 20 Degrees
Hip and KneeChange in Patellofemoral Misalignment With Q Angle´s ExamFinal Left Knee18 Degrees
Hip and KneeChange in Patellofemoral Misalignment With Q Angle´s ExamInitial Left Knee18 Degrees
Hip and KneeChange in Patellofemoral Misalignment With Q Angle´s ExamInitial Rigth Knee18 Degrees
Hip and KneeChange in Patellofemoral Misalignment With Q Angle´s ExamDelta or Change between Time point 1 and 20 Degrees
Hip and KneeChange in Patellofemoral Misalignment With Q Angle´s ExamFinal Rigth Knee18 Degrees
Hip and KneeChange in Patellofemoral Misalignment With Q Angle´s ExamDelta or change between Time point 1 and 20 Degrees
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary

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.

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)

ArmMeasureGroupValue (MEDIAN)
Core, Hip and Knee.Change in Quadriceps and Gluteus Strength With Squat´s TestSquats (Time Point 1)10 seconds
Core, Hip and Knee.Change in Quadriceps and Gluteus Strength With Squat´s TestSquats (Time point 2)35 seconds
Core, Hip and Knee.Change in Quadriceps and Gluteus Strength With Squat´s TestDelta or Change (Between Time 1 and 2)20 seconds
Hip and KneeChange in Quadriceps and Gluteus Strength With Squat´s TestSquats (Time Point 1)12.5 seconds
Hip and KneeChange in Quadriceps and Gluteus Strength With Squat´s TestSquats (Time point 2)35 seconds
Hip and KneeChange in Quadriceps and Gluteus Strength With Squat´s TestDelta or Change (Between Time 1 and 2)20 seconds
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary

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).

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)

ArmMeasureGroupValue (MEDIAN)
Core, Hip and Knee.Change in Static Balance With Single Leg StanceInitial Balance with eyes open (Right leg)11.5 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceInitial Balance with eyes closed (Right leg)20 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceBalance with eyes open (Right leg): Delta or change between Time point 1 and 211.5 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceFinal Balance with eyes closed (Right leg)28.5 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceInitial Balance with eyes closed (Left leg)24.5 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceBalance with eyes closed (Right leg): Delta or change between time point 1 and 220 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceInitial Balance with eyes open (Left leg)9.5 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceFinal Balance with eyes open (Left leg)45 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceFinal Balance with eyes closed (Left leg)30 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceFinal Balance with eyes open (Right leg)45 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceBalance with eyes closed (Left leg): Delta or change between time point 1 and 224.5 seconds
Core, Hip and Knee.Change in Static Balance With Single Leg StanceBalance with eyes open (Left leg): Delta or change between time point 1 and 29.5 seconds
Hip and KneeChange in Static Balance With Single Leg StanceBalance with eyes closed (Left leg): Delta or change between time point 1 and 220 seconds
Hip and KneeChange in Static Balance With Single Leg StanceInitial Balance with eyes open (Right leg)7.5 seconds
Hip and KneeChange in Static Balance With Single Leg StanceFinal Balance with eyes open (Right leg)45 seconds
Hip and KneeChange in Static Balance With Single Leg StanceBalance with eyes open (Right leg): Delta or change between Time point 1 and 27.5 seconds
Hip and KneeChange in Static Balance With Single Leg StanceFinal Balance with eyes open (Left leg)45 seconds
Hip and KneeChange in Static Balance With Single Leg StanceBalance with eyes open (Left leg): Delta or change between time point 1 and 220 seconds
Hip and KneeChange in Static Balance With Single Leg StanceInitial Balance with eyes closed (Right leg)19 seconds
Hip and KneeChange in Static Balance With Single Leg StanceFinal Balance with eyes closed (Right leg)23.5 seconds
Hip and KneeChange in Static Balance With Single Leg StanceBalance with eyes closed (Right leg): Delta or change between time point 1 and 219 seconds
Hip and KneeChange in Static Balance With Single Leg StanceInitial Balance with eyes closed (Left leg)20 seconds
Hip and KneeChange in Static Balance With Single Leg StanceFinal Balance with eyes closed (Left leg)20 seconds
Hip and KneeChange in Static Balance With Single Leg StanceInitial Balance with eyes open (Left leg)20 seconds
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary

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.

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)

ArmMeasureGroupValue (MEDIAN)
Core, Hip and Knee.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 FormInitial IPAQ Total Minutes3003 minutes
Core, Hip and Knee.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 FormFinal IPAQ Total Minutes4275 minutes
Core, Hip and Knee.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 FormDelta or change between Time point 1 and 21539 minutes
Hip and KneeChange in the Total Amount (Work, Transport, Home and Recreation) of Physical Activity Reported in Minutes and Measured With The International Physical Activity Questionnaire-Long FormInitial IPAQ Total Minutes1617 minutes
Hip and KneeChange in the Total Amount (Work, Transport, Home and Recreation) of Physical Activity Reported in Minutes and Measured With The International Physical Activity Questionnaire-Long FormFinal IPAQ Total Minutes4598 minutes
Hip and KneeChange in the Total Amount (Work, Transport, Home and Recreation) of Physical Activity Reported in Minutes and Measured With The International Physical Activity Questionnaire-Long FormDelta or change between Time point 1 and 21977 minutes
p-value: <0.05Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026