Protocol summary
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Study aim
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Comparison of the Effects of Sensorimotor Training versus Hip, Knee & Trunk Strengthening Exercise on Pain & Function of Patients with Patello Femoral Pain Syndrome.
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Design
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Design: Two arm parallel treatment group randomized trial. Blinding: The outcome assessor will be blind in this study. Randomization::40 participants will be randomly allocated to the 2 groups via permuted block randomization.
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Settings and conduct
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This study will be done in Clinic and Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz ,Iran on individual with Patello Femoral Pain Syndrome.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: People aged 18 to 40 years with unilateral knee anterior pain, Positive diagnostic tests of PFPS, Pain reports during specific activities
Non-inclusion criteria: People with lower limbs have other problems, such as a stroke or a history of surgery.
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Intervention groups
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Intervention group 1: Sensorimotor exercise
Intervention group 2: strengthening exercise(Hip, Knee & Trunk)
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Main outcome variables
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Pain, Function, Strength, Balance
General information
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Reason for update
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The recording of the start and end time of sampling was performed
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151118025105N5
Registration date:
2019-08-01, 1398/05/10
Registration timing:
prospective
Last update:
2021-09-29, 1400/07/07
Update count:
1
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Registration date
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2019-08-01, 1398/05/10
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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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2019-07-23, 1398/05/01
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Expected recruitment end date
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2019-10-23, 1398/08/01
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Actual recruitment start date
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2019-09-04, 1398/06/13
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Actual recruitment end date
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2020-05-05, 1399/02/16
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Trial completion date
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2020-06-05, 1399/03/16
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Scientific title
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Comparison of the Effects of Sensorimotor Training versus Hip، Knee & Trunk Strengthening Exercise on Pain & Function of Patients with Patellofemoral Pain Syndrome – A Randomized Controlled Trial
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Public title
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Comparison of the Effects of Sensorimotor Training versus Hip، Knee & Trunk Strengthening Exercise on patellofemoral pain syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Persons 18 to 40 years old with unilateral knee anterior pain
Starting spontaneous pain without any reports of knee injury
Knee pain report at least previous three months
Pain reporting in two or more cases in activities such as climbing of stairs, scatt, kneeling, jumping and prolong sitting
Moderate pain report between 3 to 7 in Numerical Pain Rating Scale at least one week
Pain during pressure testing of the patella
grind positive test or tenderness of medial and lateral facets
Exclusion criteria:
People with other knee injuries such as knee ligament injury, patellar instability, meniscal injuries, tendinopathy and osteoarthritis.
Any injury of hip, ankle and spine
Surgical history on the lower extremity
The difference in the length of the lower limbs
Peripheral and central nervous system disorders
People who take topical, oral and injectable drugs during the course of treatment
People who use medications that affect balance over the past 48 hours, as well as those who have any problems such as hearing impairments that affect balance
History of drug and alcohol abuse
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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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Both
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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participants will be randomly allocated with random block method each block size is 4 to the 2 groups. A list of randomized 4-letter permutations of the letters A and B representing groups one and two Produced with Random Allocation Random Software and the criterion is the allocation of people in groups. For example, if the ABBA permutation is generated in the first block Shows the first person in group A, Second and third in group B and the fourth in the group A. There are 10 blocks in total.
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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 assessor as well as data analyzer will be blinded to the group allocation.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2019-03-18, 1397/12/27
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Ethics committee reference number
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IR.sums.rehab.rec.1397.026
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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Patellofemoral disorders
Primary outcomes
1
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Description
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Pain
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Timepoint
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Pre and post intervention (after 4 weeks) and during follow up (after 4 weeks)
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Method of measurement
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Anterior Knee Pain Scale
2
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Description
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Function
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Timepoint
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Pre and post intervention (after 4 weeks)
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Method of measurement
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Step Down Test
Secondary outcomes
1
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Description
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Hip and Knee muscle strength(knee extensor+ hip abductor and external rotator)-Trunk flexor- Trunk extensor
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Timepoint
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Pre and post intervention (after 4 weeks)
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Method of measurement
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Hand Held Dynamometer
2
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Description
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Balance
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Timepoint
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Pre and post intervention (after 4 weeks)
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Method of measurement
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Modified Star Excursion Balance Test
Intervention groups
1
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Description
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Intervention group: intervention group 1This group will receive the sensory motor exercise for 12 sessions during a period of 4 weeks(Three sessions per week) and each session will contain 3 exercises and duration of each exercise is 5 minutes. The exercises are performed in four situations, both using ball and balance board, and without using the device.
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Category
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Rehabilitation
2
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Description
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Intervention group 2: This group will receive the hip, knee and trunk strengthening exercise for 12 sessions during a period of 4 weeks(Three sessions per week). for progress strengthenin exercise Which are done with weightcuff We use the 70% 1 Repetitive Movement, which is re-evaluated weekly and For other exercises Which are done without weightcuff progress is By changing position and increase the number of exercises.
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Category
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Rehabilitation
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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Shiraz University of Medical Sciences
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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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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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Undecided - It is not yet known if there will be 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