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Not yet recruitingNCT04631614PhD_BrunoUpdated Jun 4, 2024

Addition Effect of the Ankle Manual Therapy to Muscle Strengthening Exercise in Women With Patellofemoral Pain

An interventional study of Warm up and Passive calf muscle stretching in Patellofemoral Pain Syndrome, sponsored by Universidade Federal do Ceara. Not yet recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by Universidade Federal do Ceara · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Patellofemoral Pain Syndrome with a site in Brazil — 3 open to participants now, 3 under way, none of them phase 3. Patellofemoral Pain Syndrome · Brazil.

Planned enrollment
6th of 19
68 · median 40
Started
2024
with 1 other
No phase
18 of 21
3 open now
Registered
19th of 21
by date
Lead sponsor
4 of 21
Universidade Federal do Ceara

Among the 21 studies in Patellofemoral Pain Syndrome with a site in Brazil, this one is the 6th largest by planned enrollment of the 19 interventional ones, is one of 2 that started in 2024, is one of 18 with no phase, and was the 19th registered.

By phase

21 studies; the count open now beside each. This study's row is marked.

No phasethis study18 · 3 open
Observational2 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2008; this study’s year is marked. 2 started in 2024.

Size and results

Median enrollment 40 across the 19 interventional studies, 39 across the 2 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 21 studies in Patellofemoral Pain Syndrome with a site in Brazil, or all of them as a file.
02

Study 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. 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%.

03

Conditions studied

  • Patellofemoral Pain Syndrome

Keywords

  • knee
  • pain
  • ankle
  • manual therapy
  • exercise
04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Manual therapy plus muscle strengthening exercises

    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.

    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

  • Active comparator
    Muscle strengthening exercises

    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.

    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

Interventions

  • OtherWarm up

    Warm up through a walk or exercise bike for 5 minutes with moderate intensity according to modified Borg scale (CR-10)

  • OtherPassive calf muscle stretching

    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.

  • OtherAnkle joint mobilization - weight-bearing mobilization with movement (WB-MWM) technique

    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.

  • OtherClam exercise

    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%.

  • OtherHip abduction exercise in side lying

    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%.

  • OtherKnee extension exercise in a sitting position

    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%.

  • OtherSquat exercise

    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%.

  • OtherForward lunge exercise

    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%.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the end of the six weeks of treatment

  2. 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.

    Time frame: At the end of the six weeks of treatment

Secondary outcomes

  1. 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.

    Time frame: At 3 and 6 months follow-up

  2. 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.

    Time frame: At 3 and 6 months follow-up

  3. 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.

    Time frame: At the end of the six weeks of treatment

  4. 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.

    Time frame: At the end of the six weeks of treatment

  5. 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.

    Time frame: At the end of the six weeks of treatment.

  6. 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).

    Time frame: At the end of the six weeks of treatment.

  7. 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.

    Time frame: At the end of the six weeks of treatment.

07

Study locations

1 site
  • Bruno Augusto Lima Coelho
    Fortaleza, Ceará 60420-025, Brazil
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2024; primary completion for Dec 2024, 2 months later.

Of 153 non-industry interventional studies with no phase under Patellofemoral Pain Syndrome, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 20. This study's planned 2 months is below that.

Counting every sponsor, half of 157 studies reached it within 11 months; a quarter within 4 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2020
First posted
Nov 17, 2020
StartEst.
Oct 2024
Primary completionEst.
Dec 2024
CompletionEst.
Dec 2025
Last update
Jun 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04631614
Lead sponsor
Universidade Federal do Ceara
Responsible party
Gabriel Peixoto Leão Almeida (Professor, Universidade Federal do Ceara) — Principal investigator
First posted
Nov 17, 2020
Start date
Oct 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jun 4, 2024

Study contacts

Bruno Augusto Lima Coelho, PhD student
Contact
brunolimafisioterapia@outlook.com
+55 (85) 98804-1026
Gabriel Peixoto Leão Almeida, PhD
Contact
gabriel_alm@hotmail.com
+55 (85) 99959-0400

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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