Protocol summary
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Study aim
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To check the effects of knee and hip muscles strengthening and stretching exercises in patellofemoral pain syndrome
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Design
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Experimental
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Settings and conduct
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District Head Quarter Hospital
Study will be conduct in Orthopedic department
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Participants/Inclusion and exclusion criteria
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inclusion criteria : sedentary females with age of 21-50
Exclusion Criteria: Female who are pregnant or suffering with neurological disorders or any surgery of effected limb
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Intervention groups
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Group A will receive knee and hip muscle strengthening exercises
Group B will receive knee and hip muscle stretching exercises
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Main outcome variables
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pain
Functional status
General information
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Reason for update
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want to update acutal starting date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230615058490N2
Registration date:
2023-07-05, 1402/04/14
Registration timing:
prospective
Last update:
2023-11-24, 1402/09/03
Update count:
1
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Registration date
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2023-07-05, 1402/04/14
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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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2023-07-07, 1402/04/16
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Expected recruitment end date
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2023-08-29, 1402/06/07
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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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EFFECTS OF HIP AND KNEE MUSCLES STRENGTHENING IN IMPROVING PAIN AND FUNCTIONAL STATUS IN SEDENTARY FEMALES WITH PATELLOFEMORAL PAIN SYNDROME: A Randomized Clinical Trial
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Public title
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EFFECTS OF HIP AND KNEE MUSCLES STRENGTHENING IN IMPROVING PAIN AND FUNCTIONAL STATUS IN SEDENTARY FEMALES WITH PATELLOFEMORAL PAIN SYNDROME
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
Sedentary females of 21-50 year of age
Diagnosed by orthopedic surgeon through X-rays and physical examination.
Unilateral anterior knee pain from atleast past 3-months•
Pain in 2 or more daily activities (ascending and descending stairs,kneeling, long sitting, and pain on palpation of the medial and/or lateral facet of the patella).
Exclusion criteria:
Male gender
Pregnancy
Bilateral anterior pain syndrome• Chondromalacia patellae• Any neurological disorders
Hip or ankle injuries or previous lower extremity surgery in past 6-month
Low back pain or sacroiliac joint pain
Rheumatoid arthritis, previously used corticosteroids
Osteoarthritis, patellar instability, tendinopathies, meniscal or ligament tear and epiphysitis
Red flag sign (uncontrolled hypertension, uncontrolled diabetes and unresolved pyrexia).
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Age
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From 21 years old to 50 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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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participant will be screened according to inclusion criteria after that she will asked to choose one piece of paper on which group A or B will be mentioned.The Participant will not known which treatment protocol she will receive.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Each participants will be asked to select one piece of paper on which group A or B will be mentioned. The Participant will not known which treatment protocol she will receive.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-04-04, 1402/01/15
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Ethics committee reference number
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20752
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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M22.2
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ICD-10 code description
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arthropathies
Primary outcomes
1
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Description
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Patellofemoral pain
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Timepoint
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Pain is measured 2 times. One before apply any technique and one after 4 sessions.
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Method of measurement
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Numeric Pain Rating Scale (NPRS)
Secondary outcomes
1
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Description
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Functional Status
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Timepoint
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Functional status assessed 2 times one time before apply any technique and second time after 4 sessions.
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Method of measurement
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Lower extremity functional scale.
Intervention groups
1
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Description
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Intervention group A: This group will receive Stretching exercise for hip and knee muscles. Each individual will receive two session per week for 2 weeks. Each session will consist of ten repetitions.
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Category
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Treatment - Other
2
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Description
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Intervention group B: This group will receive Strengthening exercise for hip and knee muscles. Each individual will receive two session per week for 2 weeks. Each session will consist of ten repetitions.
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Category
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Treatment - Other
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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No
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Title of funding source
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All financial expenses will bore by myself
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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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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available