Protocol summary
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Study aim
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Comparison of the effect of proximal hip-core strengthening exercises with and without foot orthosis on improving pain and performance of women with patellofemoral pain syndrome
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Design
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A clinical trial with the control group, with parallel groups, single-blind, randomized, on 117 patients. SNOSE will used for randomization
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Settings and conduct
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The work will be done in sports clubs and orthopedic clinics. The patients will be randomly divided into three groups of 39 people using a sequentially numbered, opaque, sealed envelope (SNOSE) technique. The study will be single-blind.
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Participants/Inclusion and exclusion criteria
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Criteria for entering the study:
1. Age range between 18 and 40 years
2. Having knee pain for at least 6 weeks or more
3. Having anterior knee pain with non-traumatic origin
4. Not having a history of injury and surgery on the spine and lower limbs
5. Exacerbation of pain with at least 2 of the following activities including running, jumping, walking on stairs, sitting for a long time, kneeling, squatting
6. Navicular drop greater than 9 mm and foot posture index greater than 6
Exit criteria
If they have the following, they will be excluded from the study.
Knee meniscus and ligament or tendon damage, patella dislocation (patellar instability), Osgood Schlatter disease, Pelica syndrome, Larsen-Johnson syndrome, knee joint effusion.
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Intervention groups
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The first intervention group: Participants in this group receive hip and core proximal strengthening exercises.
The second intervention group: In addition to hip and core proximal strengthening exercises, the participants of this group also will receive foot orthosis.
The third intervention group: includes a group of people with patellofemoral pain syndrome who continue their normal lifestyle and do not receive any treatment.
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Main outcome variables
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Pain ; Performance
General information
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Reason for update
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The initial number of registered participants was regardless of the amount of attrition, which is why 6 people were added to the number of participants. Also, due to the need for more time to complete the number of participants, this period was increased.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230604058380N1
Registration date:
2023-07-28, 1402/05/06
Registration timing:
prospective
Last update:
2023-12-14, 1402/09/23
Update count:
1
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Registration date
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2023-07-28, 1402/05/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-08-21, 1402/05/30
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Expected recruitment end date
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2024-01-20, 1402/10/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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comparison of the effect of a course of course of corrective exercises with and without foot orthosis on the improvement of pain and performance of patients with patellofemoral pain syndrome.
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Public title
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Comparison of the effect of a course of corrective exercises with and without foot orthosis on people with patellofemoral pain syndrome.
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age range between 18 and 40 years
Having knee pain for at least 6 weeks or more
Having anterior knee pain with non-traumatic origin
Not having a history of injury and surgery on the spine and lower limbs
Exacerbation of pain with at least 2 of the following activities including: running, jumping, walking on a hill or stairs, sitting for a long time, kneeling, squatting
Clark's test is positive
Navicular drop more than 9 mm
A score greater than 6 from the foot posture index
Pain score greater than 3 on the visual analog scale
Exclusion criteria:
Knee meniscus and ligament or tendon injury
patellar dislocation (patellar instability)
Osgoodschlatter disease
Celica syndrome,
Larsen-Johnson syndrom
knee joint effusion
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
117
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To allocate participants to each study group by a third party who is not present in the study, sealed, numbered, and opaque envelopes will be prepared based on the number of patients. Notably, the envelope will contain a slip of paper on which the treatment will be written in coded letters (namely, ABC). Then, each participant will randomly select an envelope like a lottery and will be allocated to one of three groups (Group I: PSEFO, Group II: PSEs, or Group III: CG) according to the code in each envelope.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, the outcome evaluator is blind, so that he does not know how the subjects are assigned to the groups and what treatment intervention each group of subjects will receive. In this way, during the evaluation before and after the period of interventions, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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NO
Ethics committees
1
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Ethics committee
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Approval date
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2023-05-28, 1402/03/07
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Ethics committee reference number
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IR.GUILAN.REC.1402.021
Health conditions studied
1
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Description of health condition studied
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Patellofemoral pain syndrome
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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pain
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Timepoint
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Pain measurement before and after exercises and intervention
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Method of measurement
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Visual Analog Scale (VAS)
Secondary outcomes
1
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Description
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Disability
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Timepoint
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Measurement of functional before and after exercises and intervention
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Method of measurement
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Kujala questionnaire
2
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Description
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Balance
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Timepoint
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Measurement of functional before and after exercises and intervention
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Method of measurement
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Y balance test
3
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Description
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functional
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Timepoint
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Measurement of functional before and after exercises and intervention
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Method of measurement
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step down test at 30 second
4
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Description
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functional
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Timepoint
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Measurement of functional before and after exercises and intervention
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Method of measurement
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Single leg squat test
5
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Description
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functional
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Timepoint
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Measurement of functional before and after exercises and intervention
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Method of measurement
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bilateral squat test
6
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Description
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Q angle
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Timepoint
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Measurement of Q angle before and after exercises and intervention
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Method of measurement
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Measuring the angle Q with a goniometer
7
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Description
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Flat foot
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Timepoint
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Measurement before and after exercises and intervention
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Method of measurement
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Navicular drop
8
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Description
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Quality of life
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Timepoint
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Measurement before and after exercises and intervention
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Method of measurement
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Quality of life questionnaire (SF_36)
9
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Description
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functional
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Timepoint
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Measurement of functional before and after exercises and intervention
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Method of measurement
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anteromidial lunge test
10
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Description
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disability
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Timepoint
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Measurement disability of before and after exercises and intervention
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Method of measurement
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Kujala questionnaire
Intervention groups
1
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Description
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Intervention group: Intervention group: The first intervention group receives proximal hip and core strengthening exercises for eight weeks.
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Category
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Rehabilitation
2
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Description
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Intervention group: The second intervention group receives foot orthotics in addition toproximal strengthening hip and core exercises.
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Category
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Rehabilitation
3
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Description
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Control group: These people continue their way of life as usual.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of guilan
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No, there is no plan to publish
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available