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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Core, Hip and knee. | Experimental | Physical Exercises to strengthen the core, hip and knee. |
|
| Hip and Knee | Sham Comparator | Physical Exercises to strengthen the hip and knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strengthening program | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Alzate Granados | Universidad Nacional de Colombia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Nacional de Colombia | Bogotá | 111321 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28437495 | Background | Fulkerson JP. A Practical Guide to Understanding and Treating Patellofemoral Pain. Am J Orthop (Belle Mead NJ). 2017 Mar/Apr;46(2):101-103. | |
| 8866275 | Background | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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". |
Through study completion, about 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pt. Luisa Prieto | Universidad Nacional de Colombia | +57 3202082723 | lfprietog@unal.edu.co |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2018 | Jun 18, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2018 | Jun 18, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2018 | Jul 23, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D046788 | Patellofemoral Pain Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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).
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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.
|
| 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. | 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. | 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). | 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. | 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) |
| 26158920 | Background | 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. |
| 26834185 | Background | 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. |
| 15995421 | Background | Grelsamer RP. Patellar nomenclature: the Tower of Babel revisited. Clin Orthop Relat Res. 2005 Jul;(436):60-5. |
| 25365356 | Background | 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. |
| 29246794 | Background | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Height | Median | Inter-Quartile Range | cm |
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| BMI | Median | Inter-Quartile Range | kg/m^2 |
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| Fat Percent | Median | Inter-Quartile Range | percent |
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| Muscle Percent | Median | Inter-Quartile Range | percent |
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| Visceral Fat Percent | Median | Inter-Quartile Range | percent |
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| The International Physical Activity Questionnaire, Long Form (27-item self-reported measure) | The IPAQ-Long Version is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old. It can be used clinically and in population research that compares physical activity levels between populations internationally. The Amount of physical activity in 4 categories (work, transport, home and recreation), places patient in 1 to 3 categories: 1. Low/inactive: 2. Moderate and 3. High. To see more details about this test, please go to outcome measure number 7. | Median | Inter-Quartile Range | total minutes of physical activity |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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 |
| OG001 | 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 |
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| 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). | Posted | Median | Inter-Quartile Range | units on a scale | 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) |
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| 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. | Posted | Median | Inter-Quartile Range | Degrees | 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). |
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| 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. | Posted | Median | Inter-Quartile Range | seconds | 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) |
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| 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. | Posted | Median | Inter-Quartile Range | seconds | 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) |
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| 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). | Posted | Median | Inter-Quartile Range | seconds | 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) |
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| 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. | Posted | Median | Inter-Quartile Range | minutes | 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) |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Delta (Change between Initial and Final VAS) |
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| Delta or change between Time point 1 and 2 |
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| Initial Left Knee |
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| Final Left Knee |
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| Delta or Change between Time point 1 and 2 |
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| Plank: Delta or change between Time point 1 and 2 |
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| Lateral Plank (Right) (Time Point 1) |
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| Lateral Plank (Right) (Time Point 2) |
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| Rigth Lateral Plank: Delta or change between Time point 1 and 2 |
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| Lateral Plank (Left) (Time Point 1) |
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| Lateral Plank (Left) (Time Point 2) |
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| Left Lateral Plank: Delta or change between Time point 1 and 2 |
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| Trunk Extension (Time Point 1) |
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| Trunk Extension (Time Point 2) |
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| Trunk Extension: Delta or change between Time point 1 and 2 |
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| Delta or Change (Between Time 1 and 2) |
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| Balance with eyes open (Right leg): Delta or change between Time point 1 and 2 |
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| Initial Balance with eyes open (Left leg) |
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| Final Balance with eyes open (Left leg) |
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| Balance with eyes open (Left leg): Delta or change between time point 1 and 2 |
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| Initial Balance with eyes closed (Right leg) |
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| Final Balance with eyes closed (Right leg) |
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| Balance with eyes closed (Right leg): Delta or change between time point 1 and 2 |
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| Initial Balance with eyes closed (Left leg) |
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| Final Balance with eyes closed (Left leg) |
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| Balance with eyes closed (Left leg): Delta or change between time point 1 and 2 |
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| Delta or change between Time point 1 and 2 |
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