Patellofemoral Pain SyndromeMestradoNCT03281421
Immediate Effects of Ankle Mobilization on Dorsiflexion Range of Motion in Women With Patellofemoral Pain.
A study testing Manual Therapy in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Ceara at 1 site in Brazil.
Trial summary
Anterior Knee Pain or Patellofemoral Pain (PFP) is one of the most common disorders that affecting knee in the physically active population, being a condition that typically presents as diffuse knee pain in the anterior region and retro- or peri-patellar area, mainly in activities that increase compression force in… 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?
- Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Sep 2017to 25 Sep 2018
- 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 localized pain in the anterior region of the knee and / or around the patella, reproduced with at least two of the following activities: climbing / descending stairs, crouching, kneeling, long sitting, isometric contraction of the quadriceps, running and jump.
- Existence of a report of pain for at least three months, beginning incidental and unrelated to some traumatic event in the knee.
- Pain with intensity of at least three points in the Visual Analogue Scale (VAS) of pain in the last week.
- Limitation of the ankle dorsiflexion range of motion measured by the Lunge Test in the lower limb with Patellofemoral Pain.
Who cannot join
- History of surgery in the lumbar spine, hip, knee and / or ankle;
- History of fractures in the lumbar spine, hip, knee and / or ankle;
- History of patellar dislocation;
- Presence of edema in the knee joint;
- Presence of meniscal injury;
- Injury of cruciate ligament and / or collateral ligaments;
Show all 9Show fewer
- Presence of tendonopathy in the patellar tendon, tendons of the goose and / or band leg tibial ilium;
- Presence of Osgood-Schlatter Syndrome or Sinding-Larsen-Johansson Syndromes.
- Presence of pain in the lumbar spine and / or hip.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Ankle Mobilization on Dorsiflexion Range of Motion in Closed Kinetic Chain in Women With Patellofemoral Pain: A Random Clinical Trial
Anterior Knee Pain or Patellofemoral Pain (PFP) is one of the most common disorders that affecting knee in the physically active population, being a condition that typically presents as diffuse knee pain in the anterior region and retro- or peri-patellar area, mainly in activities that increase compression force in patellofemoral joint, such as squatting, running, stair ascent and descent. The overall prevalence of PFP has been reported as between 15-45% of the population, and its incidence is higher among women. The literature cites as etiology of PFP the ocorrence of dysfunctions in the local (knee), proximal (trunk, pelvis and hip complex) and distal (ankle and foot regions) factores. Actually, there is a lack of studies that investigate the interventions influences on distal factors in outcomes clinical in persons with PFP. Thus, the aim of this study is analyze the effect of ankle mobilization techiniques in ankle dorsiflexion range of motion closed kinetic chain in women with patellofemoral pain and with dorsoflexion restriction.
Read the detailed description
The sample of this study will be formed by 117 lower limbs of women with PFP who have ankle dorsoflexion restriction, divided into three groups. Each group will contain 39 lower limbs and receive an ankle mobilization technique with a specific sense of mobilization. The group nominated GAP will receive an mobilization technique with slip sense from anterior to posterior. The group nominated GPA will receive an mobilization technique with slip sense from posterior to anterior. The group nominated GPA-AP will receive an mobilization technique with slip sense both from posterior to anterior and from anterior to posterior.
Each group will receive a single intervention, which will consist of four sets of five repetitions of the ankle mobilization technique (according to the specific slip direction of each group), with rest time between series of one minute. In the group GPA-AP, to standardized the sequence of mobilization, the first two sets will be performed with slip sense from anterior to posterior, and the last two sets will be performede with slip sense from posterior to anterior. There will be randomisation allocation of individuals in the groups and because of the nature of the interventions only the evaluator may be blind.
The Kolmogorov - Smirnov test is used to verify the data distribution normality. The characterization of the participants is performed by means of descriptive statistical analysis. Parametric or non-parametric tests will be used according to the data distribution normality for comparison between groups at baseline. The evaluator blinding will be tested using the chi -square test by comparing the randomization code with the evaluator opinion. The difference between the groups and their respective confidence intervals will be calculated by linear mixed models using interaction term of "time versus group".
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Manual Therapy
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
Also called Manual Physical Therapy
The manual therapy intervention, through the technique of mobilization with movement in the ankle joint (following the specific sense direction of the group), will be performed in a protocol that consists of four sets of five repetitions, with rest time between series of one minute.
| Study group | Role | What they receive |
|---|---|---|
| Group from posterior to anterior (GPA) | Experimental | Participants in group GPA will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense from posterior to anterior. The physiotherapist will be positioned in front the participant's ankle, and a belt will be posicioned above the participant's malleolus and around physiotherapist's pelvis. The therapist applies with belt a anterior slip sustained in the tibia of the participant, while the talus are secured with the space between the thumb and the second finger of the hand of both hands on the physiotherapist´s. The participant will be instructed to perform a slow dorsiflexion movement at its maximum amplitude and hold five seconds in that position, returning to the initial position at the end of the five seconds. Receives: Other: Manual Therapy |
| Group from anterior to posterior (GAP) | Active comparator | Participants in group GAP will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense from anterior to posterior. The physiotherapist will be positioned behind the participant's ankle. An belt will be posicioned above the participant's malleolus and around physiotherapist's trunk. The therapist applies with belt a posterior slip sustained in the tibia of the participant, while the heel and rearfoot are secured with the space between the thumb and the second finger of the hand of both hands on the physiotherapist´s. The participant will be instructed to perform a slow dorsiflexion movement at its maximum amplitude and hold five seconds in that position, returning to the initial position at the end of the five seconds. Receives: Other: Manual Therapy |
| Group GPA-AP | Active comparator | Participants in group GAP will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense both from posterior to anterior and anterior to posterior. In the group GPA-AP, will be apllied both the procedure described for the group GPA as for the group GAP. To standardized the sequence of mobilization, the first two sets will be performed with slip sense from posterior to anterior, and the last two sets will be performede with slip sense from anterior to posterior. Receives: Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion of ankle dorsiflexion.
Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations.
Measured: Immediatly after intervention day.
Secondary outcomes (4)
Range of motion of ankle dorsiflexion.
Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations.
Measured: Two days after intervention day.
Angle of projection in the frontal plane in the lower limb.
Will be measured during the conduct of the Forward Step-Down Test through captured footage using a digital camera that will be positioned within two meters of the participant.
Measured: Immediatly and two days after intervention day.
Numeric Pain Scale.
Pain was assessed by use of an Numeric Pain Scale of eleven point, where zero corresponded to no pain and ten corresponded to worst imaginable pain
Measured: Immediatly and two days after intervention day.
Global Effect Perception Scale for Treatment
Global Effect Perception Scale for Treatment was assessed by use f an numeric scale of eleven point, where the lowest score corresponds to the extremely worst condition and the highest score corresponds to the fully recovered condition.
Measured: Immediatly and two days after intervention day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start14 Sep 2017
- Primary completion31 Mar 2018
- Study completion25 Sep 2018
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 117 participants (actual)
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
- Investigators
- Gabriel PL Almeida, MSc, Principal investigator, Federal University of Ceará (UFC), Brazil.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281421
- Sponsor's protocol ID
- Mestrado_Bruno
- Acronym
- Mestrado
- Status last verified
- Feb 2019
- First submitted
- 11 Sep 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Ankle Mobilization on Dorsiflexion Range of Motion in Closed Kinetic Chain in Women With Patellofemoral Pain: A Random Clinical Trial
- ClinicalTrials.gov ID
- NCT03281421
- Acronym / sponsor ID
- Mestrado / Mestrado_Bruno
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 13 Sep 2017 (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.
Anterior Knee Pain or Patellofemoral Pain (PFP) is one of the most common disorders that affecting knee in the physically active population, being a condition that typically presents as diffuse knee pain in the anterior region and retro- or peri-patellar area, mainly in activities that increase compression force in patellofemoral joint, such as squatting, running, stair ascent and descent. The overall prevalence of PFP has been reported as between 15-45% of the population, and its incidence is higher among women. The literature cites as etiology of PFP the ocorrence of dysfunctions in the local (knee), proximal (trunk, pelvis and hip complex) and distal (ankle and foot regions) factores. Actually, there is a lack of studies that investigate the interventions influences on distal factors in outcomes clinical in persons with PFP. Thus, the aim of this study is analyze the effect of ankle mobilization techiniques in ankle dorsiflexion range of motion closed kinetic chain in women with patellofemoral pain and with dorsoflexion restriction.
Detailed description
The sample of this study will be formed by 117 lower limbs of women with PFP who have ankle dorsoflexion restriction, divided into three groups. Each group will contain 39 lower limbs and receive an ankle mobilization technique with a specific sense of mobilization. The group nominated GAP will receive an mobilization technique with slip sense from anterior to posterior. The group nominated GPA will receive an mobilization technique with slip sense from posterior to anterior. The group nominated GPA-AP will receive an mobilization technique with slip sense both from posterior to anterior and from anterior to posterior.
Each group will receive a single intervention, which will consist of four sets of five repetitions of the ankle mobilization technique (according to the specific slip direction of each group), with rest time between series of one minute. In the group GPA-AP, to standardized the sequence of mobilization, the first two sets will be performed with slip sense from anterior to posterior, and the last two sets will be performede with slip sense from posterior to anterior. There will be randomisation allocation of individuals in the groups and because of the nature of the interventions only the evaluator may be blind.
The Kolmogorov - Smirnov test is used to verify the data distribution normality. The characterization of the participants is performed by means of descriptive statistical analysis. Parametric or non-parametric tests will be used according to the data distribution normality for comparison between groups at baseline. The evaluator blinding will be tested using the chi -square test by comparing the randomization code with the evaluator opinion. The difference between the groups and their respective confidence intervals will be calculated by linear mixed models using interaction term of "time versus group".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group from posterior to anterior (GPA) | Experimental | Other: Manual TherapyParticipants in group GPA will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense from posterior to anterior. The physiotherapist will be positioned in front the participant's ankle, and a belt will be posicioned above the participant's malleolus and around physiotherapist's pelvis. The therapist applies with belt a anterior slip sustained in the tibia of the participant, while the talus are secured with the space between the thumb and the second finger of the hand of both hands on the physiotherapist´s. The participant will be instructed to perform a slow dorsiflexion movement at its maximum amplitude and hold five seconds in that position, returning to the initial position at the end of the five seconds. |
| Group from anterior to posterior (GAP) | Active comparator | Other: Manual TherapyParticipants in group GAP will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense from anterior to posterior. The physiotherapist will be positioned behind the participant's ankle. An belt will be posicioned above the participant's malleolus and around physiotherapist's trunk. The therapist applies with belt a posterior slip sustained in the tibia of the participant, while the heel and rearfoot are secured with the space between the thumb and the second finger of the hand of both hands on the physiotherapist´s. The participant will be instructed to perform a slow dorsiflexion movement at its maximum amplitude and hold five seconds in that position, returning to the initial position at the end of the five seconds. |
| Group GPA-AP | Active comparator | Other: Manual TherapyParticipants in group GAP will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense both from posterior to anterior and anterior to posterior. In the group GPA-AP, will be apllied both the procedure described for the group GPA as for the group GAP. To standardized the sequence of mobilization, the first two sets will be performed with slip sense from posterior to anterior, and the last two sets will be performede with slip sense from anterior to posterior. |
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 localized pain in the anterior region of the knee and / or around the patella, reproduced with at least two of the following activities: climbing / descending stairs, crouching, kneeling, long sitting, isometric contraction of the quadriceps, running and jump.
- Existence of a report of pain for at least three months, beginning incidental and unrelated to some traumatic event in the knee.
- Pain with intensity of at least three points in the Visual Analogue Scale (VAS) of pain in the last week.
- Limitation of the ankle dorsiflexion range of motion measured by the Lunge Test in the lower limb with Patellofemoral Pain.
Key exclusion criteria (9 listed)
- History of surgery in the lumbar spine, hip, knee and / or ankle;
- History of fractures in the lumbar spine, hip, knee and / or ankle;
- History of patellar dislocation;
- Presence of edema in the knee joint;
- Presence of meniscal injury;
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 |
|---|---|---|
| Manual TherapyAlso: Manual Physical TherapyThe manual therapy intervention, through the technique of mobilization with movement in the ankle joint (following the specific sense direction of the group), will be performed in a protocol that consists of four sets of five repetitions, with rest time between series of one minute. | Other | Group GPA-AP, Group from anterior to posterior (GAP), Group from posterior to anterior (GPA) |
Primary outcome
Range of motion of ankle dorsiflexion.
Time frame: Immediatly after intervention day.
Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations.
4 secondary outcomes
Range of motion of ankle dorsiflexion.
Time frame: Two days after intervention day.
Angle of projection in the frontal plane in the lower limb.
Time frame: Immediatly and two days after intervention day.
Numeric Pain Scale.
Time frame: Immediatly and two days after intervention day.
Global Effect Perception Scale for Treatment
Time frame: Immediatly and two days after intervention day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Pain Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
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.
Gabriel PL Almeida, MSc principal investigator
Federal University of Ceará (UFC), Brazil.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy 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 9 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: finished, as of the sponsor's last update on 22 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion of ankle dorsiflexion. (time frame: Immediatly after intervention day.). 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 22 Feb 2019.