Protocol summary
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Study aim
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The general aim is to determine the effect of lower limb strength training with and without blood flow restriction on strength, balance and knee proprioception in people with patellofemoral pain syndrome.
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Design
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Simple random sampling individually into two intervention groups and a control group of 36 patients
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Settings and conduct
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Training place: gym and training with front leg machine and leg press.
Testing place: Biomechanics laboratory of Bahnar University (Biodex machine, hand dynamometer, photogrammetry)
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Men and women suffering from femoral patellofemoral pain syndrome with an age range of 18 to 40 years
pain with any activity, including running, jumping, squatting, kneeling, climbing/descending stairs, or prolonged sitting; pain with patellar pressure; touching the area around the patella; and pain in sitting position with resistance to isometric knee extension
Positive patellar grind (or inhibition) test
exclusion criteria:
Having a concomitant injury around the knee, including patellar laxity or dislocation and other causes of anterior knee pain (bursa, fat pad)
having diabetes
History of knee surgery in the past year
If the subject does not have the necessary cooperation to do the exercises.
The subject has pain during the exercises.
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Intervention groups
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The first group: strength exercises with 30% of maximum strength (leg extension machine and leg press machine) with blood circulation restriction
Second group: strength exercises with 70% of maximum strength ( leg extension machine and leg press machine) without blood circulation restrictions
Control group: no training
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Main outcome variables
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lower limb strength training with and without blood flow restriction on muscle strength in knee extension movement; the balance; The proprioception of people with patellofemoral pain syndrome has a different effect.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180627040251N6
Registration date:
2023-08-01, 1402/05/10
Registration timing:
prospective
Last update:
2024-06-05, 1403/03/16
Update count:
1
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Registration date
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2023-08-01, 1402/05/10
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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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2023-08-16, 1402/05/25
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Expected recruitment end date
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2023-09-21, 1402/06/30
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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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Effect of lower limb resistance exercises with and without blood flow restriction on muscle strength, balance, and knee proprioception, in people with patellofemoral pain syndrome
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Public title
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Comparison the Effect of lower limb resistance exercises with and without blood flow restriction on muscle strength, balance, and knee proprioception, in people with 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:
Men and women between the ages of 18 and 40 with femoral patellofemoral pain syndrome
pain with any activity, including (running, jumping, squatting, kneeling, climbing/descending stairs, or long sitting)
pain with patellar pressure; Touching the area around the patella
Pain in sitting position with resistance to isometric knee extension
Positive Patellar grinding test
Exclusion criteria:
Having an injury around the knee, including a laxity or dislocation of the patella
Knee ligament and meniscus injuries
Other knee injuries such as osteoarthritis of the knee, Osgoodschlatter syndrome or Sinding-Larsen-Johnson or tendinopathy of the muscles around the knee
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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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Sample size
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Target sample size:
45
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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 randomized into one of three groups (Two interventions and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed 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 assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, 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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Ethics committees
1
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Ethics committee
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Approval date
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2023-06-21, 1402/03/31
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Ethics committee reference number
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IR.SSRC.REC.1402.053
Health conditions studied
1
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Description of health condition studied
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Knee pain
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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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2
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Description of health condition studied
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Patellofemoral disorders
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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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Muscle strength
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Timepoint
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immediately before intervention; immediately after intervention
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Method of measurement
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Dynamometer
Secondary outcomes
1
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Description
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Balance
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Timepoint
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before intervention; immediately after intervention
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Method of measurement
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Biodex Balance System
2
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Description
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Knee proprioception
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Timepoint
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before intervention; immediately after intervention
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Method of measurement
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Goniometer
3
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Description
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Visual Analogue Scale
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Timepoint
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before intervention; immediately after intervention
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Method of measurement
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Score of 100 mm visual analog scale to assess pain intensity
Intervention groups
1
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Description
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The first intervention group: This group includes patients with anterior knee pain (patellofemoral pain syndrome) who are found to be treatable with physical therapy after initial examination. This group of patients has the ability to perform movements as determined by their doctor. The exercises of these people include strength exercises (front leg machine, machine leg press) with 30% of the maximum strength, which are performed with 60% arterial occlusion pressure, by closing a pneumatic cuff around the thigh for 8 weeks and 3 times a week. The exercises of this group are one set of 30 repetitions (or voluntary exhaustion), then three sets of 15 repetitions. Also, rest between sets is 30 seconds and between exercises is 2 minutes.
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Category
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Rehabilitation
2
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Description
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The second intervention group: This group includes patients with anterior knee pain (patellofemoral pain syndrome) who, after the initial examination, have been determined to be treatable with physiotherapy. This group of patients has the ability to perform movements as determined by their doctor. Exercises in this group include strength training (front leg press, machine leg press) with three sets of 7 to 10 repetitions (approximately 70% of 1RM) with BFR placebo. The placebo is a 5 cm elastic cuff that is placed tightly (with enough space for two fingers between the skin and the cuff) around the proximal thigh. This does not affect the number of repetitions performed during strength training in the initial test. Rest between sets is 30 seconds and between exercises is 2 minutes.
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Category
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Rehabilitation
3
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Description
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Control group: In the control group, there is no intervention and only pre-test and post-test are taken. They are asked not to exercise during this time.
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Category
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Placebo
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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Kharazmi University
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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