Patellofemoral Pain SyndromePhD_BrunoNCT04631614
Addition Effect of the Ankle Manual Therapy to Muscle Strengthening Exercise in Women With Patellofemoral Pain
A study testing Warm up, Passive calf muscle stretching and Ankle joint mobilization - weight-bearing mobilization with movement (WB-MWM) technique in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Ceara at 1 site in Brazil.
Trial summary
Patellofemoral pain (PFP) is the most common overuse injury of the lower limb, its prevalence is around 20% in general population, and women are more likely to develop PFP compared to men. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Warm up, Passive calf muscle stretching and Ankle joint mobilization - weight-bearing mobilization with movement (WB-MWM) technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Presence of anterior knee pain for at least 3 months, unrelated to any traumatic knee event and reproducible by performing at least two of the following activities: sitting for a long time, squatting, kneeling, ascending or descending stairs, walking or running long distances, and performing jump-landing tasks;
- Anterior knee pain in the previous week with an intensity of at least 3 points on numeric pain rating scale (NPRS);
- Score in the Anterior Knee Pain Scale less than or equal to 86 points, and;
- Limited ankle dorsiflexion range of motion in closed kinetic chain, identified by a weight-bearing lunge test in which the distance between foot and wall being less than or equal to 10 cm.
Who cannot join
- History of surgery or fracture in the lumbar spine, hip, knee, ankle, or foot;
- Referred pain from the lumbar spine, hip, ankle, or foot;
- History of patellar subluxation;
- Presence of knee swelling;
- Presence of meniscal, ligament or tendon injury, and;
- Osgood-Schlatter or Siding-Larsen-Johansson syndrome.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Bruno Augusto Lima Coelho
Fortaleza, Ceará, 60420-025
Bruno Augusto Lima Coelho, PhD student, +55 (85) 98804-1026, brunolimafisioterapia@outlook.com
Gabriel Peixoto Leão Almeida, PhD, +55 (85) 99959-0400, gabriel_alm@hotmail.com
About this study
Official title: Addition Effect of the Calf Stretching and Ankle Mobilization to Quadriceps and Gluteus Strengthening on Knee Pain and Function in Women With Patellofemoral Pain: a Randomized Controlled Trial
Patellofemoral pain (PFP) is the most common overuse injury of the lower limb, its prevalence is around 20% in general population, and women are more likely to develop PFP compared to men. PFP may develop as a result of increased pressure and joint stress due to an reduction in contact area in the patellofemoral joint. The excessive dynamic knee valgus is an important contributor to patella misalignment and for the increasing of laterally directed forces on the patella, and restriction in ankle dorsiflexion range of motion (ROM) has been previously associated with excessive dynamic knee valgus. Although the evidence shows that strengthening exercises for the quadriceps and gluteus promote improvement of knee pain and function, there is a lack of studies that investigate if targeted interventions for improvement ankle dorsiflexion may promote additional benefits in knee pain and function when performed in combination with strengthening exercises. Thus, the aimed of this study is analyze the addition effect of calf stretching and ankle mobilization to quadriceps and gluteus strengthening on knee pain and function in women with PFP who display ankle dorsiflexion restriction.
Read the detailed description
The study sample will be formed by 68 women with PFP who show ankle dorsiflexion restriction, divided into two groups: Experimental Group (EG, n = 34), that will receive two manual therapy techniques (calf muscle stretching and ankle mobilization) followed by five muscle strengthening exercises focusing on quadriceps and posterolateral hip complex (PHC), and; Control Group (CG, n = 34), that will receive only the five muscle strengthening exercises focusing on quadriceps and PHC. The treatment sessions will be individual and supervised by a physiotherapist, will last 40-50 minutes and will perform twice a week for six weeks. Before starting each treatment session, both groups will perform warm up with a walk or exercise bike for 5 minutes.
The calf muscle stretching will be performed passively in two repetitions with 30 seconds of held in the stretching position and 30 seconds of rest between repetitions. The ankle mobilization will be performed using the Weight-bearing Mobilization with Movement (WB-MWM) technique, being applied in two sets of 10 repetitions with two minutes of rest between sets.
The five muscle strengthening exercises will be as follows: (a) clam exercise; (b) hip abduction exercise in side lying; (c) knee extension exercise in a sitting position; (d) squat exercise, and; (e) forward lunge exercise. All exercises will be performed in three sets of 12 repetitions with on minutes of rest between sets and two minutes of rest between exercises.
Regarding the intensity of the exercises, this will be monitored by the physiotherapist according to the perception of the level of effort and difficulty reported by the participant when completing the series of each exercise, according to the specifications of the modified Borg scale (CR-10). The exercises will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant. The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last series of the exercise with perceived effort <60%.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Warm up, Passive calf muscle stretching, Ankle joint mobilization - weight-bearing mobilization with movement (WB-MWM) technique, Clam exercise, Hip abduction exercise in side lying
- Keywords
- knee, pain, ankle, manual therapy, exercise
- Medical subject headings
- Patellofemoral Pain Syndrome, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm upOther
Warm up through a walk or exercise bike for 5 minutes with moderate intensity according to modified Borg scale (CR-10)
Passive calf muscle stretchingOther
With the participant lying in the supine position, the physiotherapist will passively perform the ankle dorsiflexion movement to stretch the participant's calf to the limit tolerated by the participant. This procedure will be performed in two repetitions with 30 seconds of held in the stretching position and 30 seconds of rest between repetitions.
Ankle joint mobilization - weight-bearing mobilization with movement (WB-MWM) techniqueOther
To perform the WB-MWM technique, the participant will be instructed to take a weight-bearing position with the tibia in a vertical position. The physiotherapist will be stay in front participant's ankle and will use the hands to stabilize the participant's foot as close as possible to the anterior region of the talus. A rigid belt will be placed on the participant's tibia and around physiotherapist´s hip. Then, the physiotherapist will project his hip backwards to produce a nonpainful anterior tibia glide. The participant will be asked to perform a forward lunge as far as possible without raising heel off the table and without reproducing knee symptoms. After achieving the maximum forward lunge, the participant will be instructed to hold this position for 5 seconds and then return to the starting position. This procedure will be performed in two sets of 10 repetitions with two minutes of rest between sets.
Clam exerciseOther
The participant will side lying with trunk straight and both hips and knees at 45º and 90º of flexion, respectively. An elastic band will be used as external resistance, that will be positioned above the participant's knee. The individual will be instructed to perform the abduction and lateral rotation of the hip (keeping the heels in contact) against the resistance of the elastic band and then return to starting position. This exercise will be performed in three sets of 12 repetitions with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%.
Hip abduction exercise in side lyingOther
The participant will side lying with trunk straight, both hips in a neutral position and both knee in extension. An elastic band will be used as external resistance, that will be positioned above the participant's knee. The individual will be instructed to perform the hip abduction against the resistance of the elastic band and then return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%.
Knee extension exercise in a sitting positionOther
The participant will be seated at the treatment table with the trunk straight and both knees in 90º of flexion. The external resistance will be positioned above the participant's ankle. The individual will be instructed to perform the knee extension at a protective angle (90º-45º of flexion), progressing to full extension (90º-0º of flexion) as long as the full knee extension does not reproduce the knee pain symptoms. Then, the participant will should return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%.
Squat exerciseOther
The participant will be stand with the trunk straight, knees in extension and feet hip-width apart. Dumbbells will be used as external resistance.The individual will be instructed to perform the squat movement at a protective angle (0º-45º of knee flexion), progressing to a deep squat (90º of knee flexion) as long as the movement does not reproduce the knee pain symptoms. Then, the participant will should return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%.
Forward lunge exerciseOther
The participant will be stand with one lower limb in a long stride forwards of the other limb, trunk straight and both knee in extension. Dumbbells will be used as external resistance. From this position, the participant will be instructed to bend both knees to lower your body at a protective angle (0º-45º of knee flexion), progressing to a greater knee flexion (90º) as long as the movement does not reproduce the knee pain symptoms. Then, the participant will should return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy plus muscle strengthening exercises | Experimental | The procedures to be performed with participants in the experimental group are as follows: (1) warm up with a walk or exercise bike for 5 minutes; (2) two ankle manual therapy techniques - [a] passive calf muscle stretching and [b] ankle joint mobilization; (3) five muscle strengthening exercises focusing on quadriceps and posterolateral hip complex - [a] clam exercise, [b] hip abduction exercise in side lying, [c] knee extension exercise in a sitting position, [d] squat exercise and [e] forward lunge exercise. Receives: Other: Warm up; Other: Passive calf muscle stretching; Other: Ankle joint mobilization - weight-bearing mobilization with movement (WB-MWM) technique; Other: Clam exercise; Other: Hip abduction exercise in side lying; Other: Knee extension exercise in a sitting position; Other: Squat exercise; Other: Forward lunge exercise |
| Muscle strengthening exercises | Active comparator | The procedures to be performed with participants in the control group are as follows: (1) warm up with a walk or exercise bike for 5 minutes; (2) five muscle strengthening exercises focusing on quadriceps and posterolateral hip complex - [a] clam exercise, [b] hip abduction exercise in side lying, [c] knee extension exercise in a sitting position, [d] squat exercise and [e] forward lunge exercise. Receives: Other: Warm up; Other: Clam exercise; Other: Hip abduction exercise in side lying; Other: Knee extension exercise in a sitting position; Other: Squat exercise; Other: Forward lunge exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Pain will be assessed by use of an 11-point Numeric Pain Scale, where 0 correspond to no pain and 10 correspond to worst imaginable pain.
Measured: At the end of the six weeks of treatment
Anterior Knee Pain Scale
The subjective functional capacity of the participant will be recorded with the translated and validated Portuguese-language version of the Anterior Knee Pain Scale (AKPS). The scores for this scale, 0 to 100, represent the lowest to the highest levels of functional capacity, respectively.
Measured: At the end of the six weeks of treatment
Secondary outcomes (7)
Numeric Pain Rating Scale
Pain will be assessed by use of an 11-point Numeric Pain Scale, where 0 correspond to no pain and 10 correspond to worst imaginable pain.
Measured: At 3 and 6 months follow-up
Anterior Knee Pain Scale
The subjective functional capacity of the participant will be recorded with the translated and validated Portuguese-language version of the Anterior Knee Pain Scale (AKPS). The scores for this scale, 0 to 100, represent the lowest to the highest levels of functional capacity, respectively.
Measured: At 3 and 6 months follow-up
Weight-Bearing Lunge Test
The ankle dorsiflexion range of motion in closed kinetic chain will be measured by the distance between foot and wall in the weight-bearing lunge test.
Measured: At the end of the six weeks of treatment
Dynamic knee valgus
The dynamic knee valgus will be assessed by 2D kinematic through measurement of frontal plane projection angle of the knee during the forward step-down test.
Measured: At the end of the six weeks of treatment
Isometric strength of the quadriceps
The quadriceps isometric strength will be assessed using a handheld dynamometer (Nicholas Manual Muscle Test, Lafayette Instrument Company, Lafayette, Indiana, USA). The evaluation will be performed with the participant in a sitting position, straight trunk and knee at 90º of flexion.
Measured: At the end of the six weeks of treatment.
Isometric strength of the hip posterolateral complex
The hip posterolateral complex isometric strength will be assessed using a handheld dynamometer (Nicholas Manual Muscle Test, Lafayette Instrument Company, Lafayette, Indiana, USA) during the Hip Stability Isometric Test (HipSIT).
Measured: At the end of the six weeks of treatment.
Global Effect Perception Scale for Treatment
The participant's perception of treatment will be assessed by use of an 11-point Global Effect Perception Scale , where +5 correspond to perception of great improvement and -5 correspond to perception of great worsening.
Measured: At the end of the six weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study startOct 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631614
- Sponsor's protocol ID
- PhD_Bruno
- Acronym
- PhD_Bruno
- Status last verified
- Jun 2024
- First submitted
- 10 Nov 2020
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition Effect of the Calf Stretching and Ankle Mobilization to Quadriceps and Gluteus Strengthening on Knee Pain and Function in Women With Patellofemoral Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04631614
- Acronym / sponsor ID
- PhD_Bruno / PhD_Bruno
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- knee, pain, ankle, manual therapy, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patellofemoral pain (PFP) is the most common overuse injury of the lower limb, its prevalence is around 20% in general population, and women are more likely to develop PFP compared to men. PFP may develop as a result of increased pressure and joint stress due to an reduction in contact area in the patellofemoral joint. The excessive dynamic knee valgus is an important contributor to patella misalignment and for the increasing of laterally directed forces on the patella, and restriction in ankle dorsiflexion range of motion (ROM) has been previously associated with excessive dynamic knee valgus. Although the evidence shows that strengthening exercises for the quadriceps and gluteus promote improvement of knee pain and function, there is a lack of studies that investigate if targeted interventions for improvement ankle dorsiflexion may promote additional benefits in knee pain and function when performed in combination with strengthening exercises. Thus, the aimed of this study is analyze the addition effect of calf stretching and ankle mobilization to quadriceps and gluteus strengthening on knee pain and function in women with PFP who display ankle dorsiflexion restriction.
Detailed description
The study sample will be formed by 68 women with PFP who show ankle dorsiflexion restriction, divided into two groups: Experimental Group (EG, n = 34), that will receive two manual therapy techniques (calf muscle stretching and ankle mobilization) followed by five muscle strengthening exercises focusing on quadriceps and posterolateral hip complex (PHC), and; Control Group (CG, n = 34), that will receive only the five muscle strengthening exercises focusing on quadriceps and PHC. The treatment sessions will be individual and supervised by a physiotherapist, will last 40-50 minutes and will perform twice a week for six weeks. Before starting each treatment session, both groups will perform warm up with a walk or exercise bike for 5 minutes.
The calf muscle stretching will be performed passively in two repetitions with 30 seconds of held in the stretching position and 30 seconds of rest between repetitions. The ankle mobilization will be performed using the Weight-bearing Mobilization with Movement (WB-MWM) technique, being applied in two sets of 10 repetitions with two minutes of rest between sets.
The five muscle strengthening exercises will be as follows: (a) clam exercise; (b) hip abduction exercise in side lying; (c) knee extension exercise in a sitting position; (d) squat exercise, and; (e) forward lunge exercise. All exercises will be performed in three sets of 12 repetitions with on minutes of rest between sets and two minutes of rest between exercises.
Regarding the intensity of the exercises, this will be monitored by the physiotherapist according to the perception of the level of effort and difficulty reported by the participant when completing the series of each exercise, according to the specifications of the modified Borg scale (CR-10). The exercises will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant. The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last series of the exercise with perceived effort <60%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy plus muscle strengthening exercises | Experimental | Other: Warm up, Other: Passive calf muscle stretching, Other: Ankle joint mobilization - weight-bearing mobilization with movement (WB-MWM) technique, Other: Clam exercise, Other: Hip abduction exercise in side lying, Other: Knee extension exercise in a sitting position, Other: Squat exercise, Other: Forward lunge exerciseThe procedures to be performed with participants in the experimental group are as follows: (1) warm up with a walk or exercise bike for 5 minutes; (2) two ankle manual therapy techniques - [a] passive calf muscle stretching and [b] ankle joint mobilization; (3) five muscle strengthening exercises focusing on quadriceps and posterolateral hip complex - [a] clam exercise, [b] hip abduction exercise in side lying, [c] knee extension exercise in a sitting position, [d] squat exercise and [e] forward lunge exercise. |
| Muscle strengthening exercises | Active comparator | Other: Warm up, Other: Clam exercise, Other: Hip abduction exercise in side lying, Other: Knee extension exercise in a sitting position, Other: Squat exercise, Other: Forward lunge exerciseThe procedures to be performed with participants in the control group are as follows: (1) warm up with a walk or exercise bike for 5 minutes; (2) five muscle strengthening exercises focusing on quadriceps and posterolateral hip complex - [a] clam exercise, [b] hip abduction exercise in side lying, [c] knee extension exercise in a sitting position, [d] squat exercise and [e] forward lunge exercise. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of anterior knee pain for at least 3 months, unrelated to any traumatic knee event and reproducible by performing at least two of the following activities: sitting for a long time, squatting, kneeling, ascending or descending stairs, walking or running long distances, and performing jump-landing tasks;
- Anterior knee pain in the previous week with an intensity of at least 3 points on numeric pain rating scale (NPRS);
- Score in the Anterior Knee Pain Scale less than or equal to 86 points, and;
- Limited ankle dorsiflexion range of motion in closed kinetic chain, identified by a weight-bearing lunge test in which the distance between foot and wall being less than or equal to 10 cm.
Key exclusion criteria (6 listed)
- History of surgery or fracture in the lumbar spine, hip, knee, ankle, or foot;
- Referred pain from the lumbar spine, hip, ankle, or foot;
- History of patellar subluxation;
- Presence of knee swelling;
- Presence of meniscal, ligament or tendon injury, and;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm upWarm up through a walk or exercise bike for 5 minutes with moderate intensity according to modified Borg scale (CR-10) | Other | Manual therapy plus muscle strengthening exercises, Muscle strengthening exercises |
| Passive calf muscle stretchingWith the participant lying in the supine position, the physiotherapist will passively perform the ankle dorsiflexion movement to stretch the participant's calf to the limit tolerated by the participant. This procedure will be performed in two repetitions with 30 seconds of held in the stretching position and 30 seconds of rest between repetitions. | Other | Manual therapy plus muscle strengthening exercises |
| Ankle joint mobilization - weight-bearing mobilization with movement (WB-MWM) techniqueTo perform the WB-MWM technique, the participant will be instructed to take a weight-bearing position with the tibia in a vertical position. The physiotherapist will be stay in front participant's ankle and will use the hands to stabilize the participant's foot as close as possible to the anterior region of the talus. A rigid belt will be placed on the participant's tibia and around physiotherapist´s hip. Then, the physiotherapist will project his hip backwards to produce a nonpainful anterior tibia glide. The participant will be asked to perform a forward lunge as far as possible without raising heel off the table and without reproducing knee symptoms. After achieving the maximum forward lunge, the participant will be instructed to hold this position for 5 seconds and then return to the starting position. This procedure will be performed in two sets of 10 repetitions with two minutes of rest between sets. | Other | Manual therapy plus muscle strengthening exercises |
| Clam exerciseThe participant will side lying with trunk straight and both hips and knees at 45º and 90º of flexion, respectively. An elastic band will be used as external resistance, that will be positioned above the participant's knee. The individual will be instructed to perform the abduction and lateral rotation of the hip (keeping the heels in contact) against the resistance of the elastic band and then return to starting position. This exercise will be performed in three sets of 12 repetitions with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%. | Other | Manual therapy plus muscle strengthening exercises, Muscle strengthening exercises |
| Hip abduction exercise in side lyingThe participant will side lying with trunk straight, both hips in a neutral position and both knee in extension. An elastic band will be used as external resistance, that will be positioned above the participant's knee. The individual will be instructed to perform the hip abduction against the resistance of the elastic band and then return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%. | Other | Manual therapy plus muscle strengthening exercises, Muscle strengthening exercises |
| Knee extension exercise in a sitting positionThe participant will be seated at the treatment table with the trunk straight and both knees in 90º of flexion. The external resistance will be positioned above the participant's ankle. The individual will be instructed to perform the knee extension at a protective angle (90º-45º of flexion), progressing to full extension (90º-0º of flexion) as long as the full knee extension does not reproduce the knee pain symptoms. Then, the participant will should return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%. | Other | Manual therapy plus muscle strengthening exercises, Muscle strengthening exercises |
| Squat exerciseThe participant will be stand with the trunk straight, knees in extension and feet hip-width apart. Dumbbells will be used as external resistance.The individual will be instructed to perform the squat movement at a protective angle (0º-45º of knee flexion), progressing to a deep squat (90º of knee flexion) as long as the movement does not reproduce the knee pain symptoms. Then, the participant will should return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%. | Other | Manual therapy plus muscle strengthening exercises, Muscle strengthening exercises |
| Forward lunge exerciseThe participant will be stand with one lower limb in a long stride forwards of the other limb, trunk straight and both knee in extension. Dumbbells will be used as external resistance. From this position, the participant will be instructed to bend both knees to lower your body at a protective angle (0º-45º of knee flexion), progressing to a greater knee flexion (90º) as long as the movement does not reproduce the knee pain symptoms. Then, the participant will should return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%. | Other | Manual therapy plus muscle strengthening exercises, Muscle strengthening exercises |
Primary outcome
Numeric Pain Rating Scale
Time frame: At the end of the six weeks of treatment
Pain will be assessed by use of an 11-point Numeric Pain Scale, where 0 correspond to no pain and 10 correspond to worst imaginable pain.
Anterior Knee Pain Scale
Time frame: At the end of the six weeks of treatment
The subjective functional capacity of the participant will be recorded with the translated and validated Portuguese-language version of the Anterior Knee Pain Scale (AKPS). The scores for this scale, 0 to 100, represent the lowest to the highest levels of functional capacity, respectively.
7 secondary outcomes
Numeric Pain Rating Scale
Time frame: At 3 and 6 months follow-up
Anterior Knee Pain Scale
Time frame: At 3 and 6 months follow-up
Weight-Bearing Lunge Test
Time frame: At the end of the six weeks of treatment
Dynamic knee valgus
Time frame: At the end of the six weeks of treatment
Isometric strength of the quadriceps
Time frame: At the end of the six weeks of treatment.
Isometric strength of the hip posterolateral complex
Time frame: At the end of the six weeks of treatment.
Global Effect Perception Scale for Treatment
Time frame: At the end of the six weeks of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm up, Passive calf muscle stretching and Ankle joint mobilization - weight-bearing mobilization with movement (WB-MWM) technique in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Ceara at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Augusto Lima Coelho, PhD student (+55 (85) 98804-1026, brunolimafisioterapia@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: At the end of the six weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.