An interventional study of Strengthening program in Patellofemoral Pain Syndrome, sponsored by Universidad Nacional de Colombia. Completed at 1 site in Colombia. Open to participants aged 15 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by Universidad Nacional de Colombia · Not applicable, Interventional, and Treatment
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.
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).
295 studies on the registry are indexed under Patellofemoral Pain Syndrome; 75 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 242 interventional studies indexed under Patellofemoral Pain Syndrome.
Browse Patellofemoral Pain Syndrome studies →Universidad Nacional de Colombia is the lead sponsor of 38 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Physical Exercises to strengthen the core, hip and knee.
Other: Strengthening program
Physical Exercises to strengthen the hip and knee.
Other: 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
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".
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)
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).
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)
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)
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)
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)
| Milestone | Core, Hip and Knee. | Hip and Knee |
|---|---|---|
| Started | 20 | 20 |
| Completed | 19 | 19 |
| Not completed | 1 | 1 |
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.
| percentage of participants | Core, Hip and Knee. | Hip and Knee |
|---|---|---|
| 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) |
| Percentage of participants with not inflammation | 15 (4.5 to 39.2) | 40 (20.5 to 63.2) |
| Percentage of participants with severe atrophy | 0 (0 to 0) | 5 (0.6 to 30.6) |
| Percentage of participants with mild atrophy | 15 (4.5 to 39.2) | 30 (13.4 to 54.1) |
| Percentage of participants with not atrophy | 85 (60.7 to 95.4) | 70 (45.8 to 86.5) |
| Percentage of participants with lameness constantly | 10 (2.31 to 34.2) | 10 (2.31 to 34.2) |
| Percentage of participants with lameness a little, sometimes | 80 (55.6 to 92.7) | 75 (50.6 to 89.7) |
| Percentage of participants with no limp | 10 (2.31 to 34.2) | 15 (4.59 to 39.2) |
| Percentage of participants with impossible to support the limb | 10 (2.31 to 34.2) | 5 (0.6 to 30.6) |
| Percentage of participants with pain with limb support | 55 (32.4 to 75.6) | 80 (55.6 to 92.7) |
| Percentage of participants with the extremity completely painless | 35 (16.9 to 58.7) | 15 (4.59 to 39.2) |
| Percentage of participants that can't walk | 5 (0.6 to 30.6) | 5 (0.6 to 30.6) |
| Percentage of participants that can walk between 1-2 Km | 20 (7.2 to 44.3) | 25 (10.2 to 49.3) |
| Percentage of participants that can walk more than 2 km | 45 (24.3 to 67.5) | 45 (24.3 to 67.5) |
| Percentage of participants that can walk without limit | 30 (13.4 to 54.1) | 25 (10.2 to 49.3) |
| Percentage of participants that are not able to go up and down stairs | 5 (0.6 to 30.6) | 0 (0 to 0) |
| Percentage of participants with pain when going up and down the stairs | 50 (28.3 to 71.6) | 75 (54.9 to 95) |
| Percentage of participants with slight pain when going down the stairs | 45 (24.3 to 67.5) | 15 (4.59 to 39.2) |
| Percentage of participants that can go up and down the stairs without difficulty | 0 (0 to 0) | 10 (2.31 to 34.2) |
| Percentage of participants that can't do squats | 20 (7.2 to 44.39) | 0 (0 to 0) |
| Percentage of participants that can do squats with help | 5 (0.6 to 30.6) | 15 (4.59 to 39.2) |
| Percentage of participants that are always in pain when doing squats | 20 (0.6 to 30.6) | 40 (20.5 to 63.2) |
| Percentage of participants with pain when doing squats quickly | 25 (7.26 to 44.39) | 40 (20.5 to 63.2) |
| Percentage of participants squating without difficulty | 30 (13.4 to 54.1) | 5 (0.6 to 30.6) |
| Percentage of participants unable to remain seated with knees bent | 15 (4.59 to 39.2) | 0 (0 to 0) |
| Percentage of participants with pain forces him/her to extend his knees | 65 (41.2 to 83) | 70 (45.8 to 86.5) |
| Percentage of participants that are always in pain to sit with their knees bent | 10 (2.31 to 34.2) | 10 (2.31 to 34.2) |
| Percentage of participants with only pain if they have exercised | 5 (0.6 to 30.6) | 20 (7.26 to 44.3) |
| Percentage of participants with no problem sitting with their knees bent | 5 (0.6 to 30.6) | 0 (0 to 0) |
| Percentage of participants with more than two dislocations of the patella | 10 (2.31 to 34.2) | 10 (2.31 to 34.2) |
| Percentage of participants with less than a confirmed dislocation | 10 (2.31 to 34.2) | 15 (4.59 to 39.2) |
| Percentage of participants with dislocations occasionally with daily activities | 20 (7.26 to 44.36) | 40 (20.5 to 63.2) |
| Percentage of participants with dislocations occasionally with exercise | 30 (13.4 to 54.1) | 30 (13.4 to 54.1) |
| Percentage of participants with no dislocations of the patella | 30 (13.4 to 54.1) | 5 (0.6 to 30.6) |
| Percentage of participants with severe deficiency for knee flexion | 20 (7.26 to 44.3) | 5 (0.6 to 30.6) |
| Percentage of participants with mild deficiency for knee flexion | 70 (45.8 to 86.5) | 70 (45.8 to 86.5) |
| Percentage of participants with no deficiency for knee flexion | 10 (2.31 to 34.2) | 25 (10.2 to 49.3) |
| Percentage of participants unable to run | 25 (10.2 to 49.3) | 15 (4.59 to 39.2) |
| Percentage of participants with severe pain always when running | 0 (0 to 0) | 15 (4.59 to 39.2) |
| Percentage of participants with slight pain since starting to run | 25 (10.2 to 49.3) | 25 (10.2 to 49.3) |
| Percentage of participants with pain after 2 km of running | 35 (16.9 to 58.7) | 35 (16.9 to 58.7) |
| Percentage of participants that can run without limit | 15 (4.59 to 39.2) | 10 (2.31 to 34.2) |
| Percentage of participants unable to jump | 25 (10.2 to 49.3) | 30 (13.4 to 54.1) |
| Percentage of participants with permanent pain when jumping | 15 (4.59 to 39.2) | 20 (7.26 to 44.3) |
| Percentage of participants with slight difficulty jumping | 35 (16.9 to 58.7) | 35 (16.9 to 58.7) |
| Percentage of participants with no difficulty jumping | 25 (10.2 to 49.3) | 15 (4.59 to 39.2) |
Visual Analogue Scale (VAS) is a numeric scale from 0 to 10 to measure pain (been 0 no pain and 10 worse pain).
| units on a scale | Core, Hip and Knee. | Hip and Knee |
|---|---|---|
| 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) |
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.
| Degrees | Core, Hip and Knee. | Hip and Knee |
|---|---|---|
| Initial Rigth Knee | 19 (15 to 20) | 18 (15 to 20) |
| Final Rigth Knee | 18 (15 to 20) | 18 (15 to 20) |
| Delta or change between Time point 1 and 2 | 0 (-2 to 2) | 0 (-2 to 2) |
| Initial Left Knee | 18 (15 to 20) | 18 (15 to 20) |
| Final Left Knee | 18 (16 to 20) | 18 (15 to 20) |
| Delta or Change between Time point 1 and 2 | 0 (-2 to 2) | 0 (-2 to 2) |
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.
| seconds | Core, Hip and Knee. | Hip and Knee |
|---|---|---|
| Plank (Time Point 1) | 20.5 (12 to 32) | 30 (13.5 to 33.5) |
| Plank (Time Point 2) | 60 (45 to 70) | 35 (20 to 60) |
| Plank: Delta or change between Time point 1 and 2 | 37 (24 to 48) | 10 (2.0 to 15) |
| Lateral Plank (Right) (Time Point 1) | 15 (10 to 21) | 15 (9.5 to 20) |
| Lateral Plank (Right) (Time Point 2) | 45 (38 to 51) | 22 (16 to 38) |
| Rigth Lateral Plank: Delta or change between Time point 1 and 2 | 30 (19 to 36) | 6 (2 to 12) |
| Lateral Plank (Left) (Time Point 1) | 12.5 (10.5 to 19) | 18 (11 to 23) |
| Lateral Plank (Left) (Time Point 2) | 45 (36 to 56) | 21 (15 to 34) |
| Left Lateral Plank: Delta or change between Time point 1 and 2 | 30 (17 to 40) | 5 (-2 to 10) |
| Trunk Extension (Time Point 1) | 13.5 (6.0 to 26.5) | 13.5 (2.5 to 20) |
| Trunk Extension (Time Point 2) | 61 (50 to 75) | 30 (15 to 60) |
| Trunk Extension: Delta or change between Time point 1 and 2 | 49 (30 to 55) | 15 (7 to 34) |
Squat Test is a field test, easy and simple to assess the Gluteus and quadriceps muscles strength.
| seconds | Core, Hip and Knee. | Hip and Knee |
|---|---|---|
| Squats (Time Point 1) | 10 (8 to 18.5) | 12.5 (8.5 to 20) |
| Squats (Time point 2) | 35 (30 to 38) | 35 (29 to 38) |
| Delta or Change (Between Time 1 and 2) | 20 (18 to 25) | 20 (15 to 24) |
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).
| seconds | Core, Hip and Knee. | Hip and Knee |
|---|---|---|
| Initial Balance with eyes open (Right leg) | 11.5 (0 to 25.5) | 7.5 (0 to 30) |
| Final Balance with eyes open (Right leg) | 45 (45 to 45) | 45 (45 to 45) |
| Balance with eyes open (Right leg): Delta or change between Time point 1 and 2 | 11.5 (0 to 25.5) | 7.5 (0 to 30) |
| Initial Balance with eyes open (Left leg) | 9.5 (0 to 21.5) | 20 (0 to 30) |
| Final Balance with eyes open (Left leg) | 45 (45 to 45) | 45 (45 to 45) |
| Balance with eyes open (Left leg): Delta or change between time point 1 and 2 | 9.5 (0 to 21.5) | 20 (0 to 30) |
| Initial Balance with eyes closed (Right leg) | 20 (14 to 27.5) | 19 (9.5 to 24) |
| Final Balance with eyes closed (Right leg) | 28.5 (21 to 35) | 23.5 (16.5 to 31.5) |
| Balance with eyes closed (Right leg): Delta or change between time point 1 and 2 | 20 (14 to 27.5) | 19 (9.5 to 24) |
| Initial Balance with eyes closed (Left leg) | 24.5 (13 to 30.5) | 20 (10.5 to 30.5) |
| Final Balance with eyes closed (Left leg) | 30 (23.5 to 38) | 20 (10.5 to 30.5) |
| Balance with eyes closed (Left leg): Delta or change between time point 1 and 2 | 24.5 (13 to 30.5) | 20 (10.5 to 30.5) |
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.
| minutes | Core, Hip and Knee. | Hip and Knee |
|---|---|---|
| Initial IPAQ Total Minutes | 3003 (1116 to 4638) | 1617 (944 to 6138) |
| Final IPAQ Total Minutes | 4275 (2587 to 6522) | 4598 (2888 to 7344) |
| Delta or change between Time point 1 and 2 | 1539 (807 to 2457) | 1977 (1191 to 2815) |
Collected over Through study completion, about 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Core, Hip and Knee. | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Hip and Knee | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Core, Hip and Knee. | Hip and Knee | Total |
|---|---|---|---|
| Age — <=18 years | 2 | 2 | 4 |
| Age — Between 18 and 65 years | 18 | 18 | 36 |
| Age — >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Core, Hip and Knee. | Hip and Knee | Total |
|---|---|---|---|
| Median | 32.5 (25.5 to 38) | 29 (25 to 36.5) | 30.75 (25.25 to 37.25) |
| Sex: Female, Male(Participants) | Core, Hip and Knee. | Hip and Knee | Total |
|---|---|---|---|
| Female | 18 | 18 | 36 |
| Male | 2 | 2 | 4 |
| Race and Ethnicity Not Collected(Participants) | Core, Hip and Knee. | Hip and Knee | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Core, Hip and Knee. | Hip and Knee | Total |
|---|---|---|---|
| Colombia | 20 | 20 | 40 |
| Height(cm) | Core, Hip and Knee. | Hip and Knee | Total |
|---|---|---|---|
| Median | 160 (156.5 to 167) | 159.5 (154 to 163) | 159.75 (155.25 to 165) |
| BMI(kg/m^2) | Core, Hip and Knee. | Hip and Knee | Total |
|---|---|---|---|
| Median | 25.4 (21.5 to 27.9) | 23.8 (22.3 to 25.2) | 24.6 (21.9 to 26.55) |
| Fat Percent(percent) | Core, Hip and Knee. | Hip and Knee | Total |
|---|---|---|---|
| Median | 35.4 (28.9 to 40.4) | 35.4 (24.5 to 38.7) | 35.4 (26.7 to 39.6) |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
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Universidad Nacional de Colombia