To investigate the effects of the lateral wedged insoles and knee orthoses on the knee dynamic valgus in people with patellofemoral pain syndrome
Design
A crossover study with 15 participants
Settings and conduct
Participants were recruited from outpatient clinics through a convenience sampling method.
Participants/Inclusion and exclusion criteria
Inclusion criteria were positive sign for " Patella Femoral Grinding test" and
score more than three on visual analogue scale. Exclusion criteria included presence of a history of fracture and surgery in the lower limb and Instability of the knee due to trauma and other musculoskeletal disorders.
Intervention groups
Interventions were using lateral wedge insole, knee support, lateral wedge and knee support together.
Main outcome variables
The Main outcome measures were parameters of the gait pattern, valgus angle at the knee, and pain intensity during squat.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150210021034N4
Registration date:2020-01-07, 1398/10/17
Registration timing:retrospective
Last update:2020-01-07, 1398/10/17
Update count:0
Registration date
2020-01-07, 1398/10/17
Registrant information
Name
Ebrahim Sadeghi-Demneh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5235
Email address
sadeghi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
2015-09-23, 1394/07/01
Actual recruitment end date
2016-05-30, 1395/03/10
Trial completion date
2016-06-14, 1395/03/25
Scientific title
Effects of the lateral wedged insoles and knee orthoses on the knee dynamic valgus in people with patellofemoral pain syndrome
Public title
Orthosis and Insole for patellar pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Positive Patella Femoral Grinding test
Score more than three on visual analogue scale
Age over 18 years
Exclusion criteria:
The history of fracture and surgery in the lower limb
Instability of the knee due to trauma and other musculoskeletal disorders
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Actual sample size reached:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ُthical committee of Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2015-09-27, 1394/07/05
Ethics committee reference number
IR.MUI.REC.1394.3.452
Health conditions studied
1
Description of health condition studied
Patellofemoral Pain Syndrom
ICD-10 code
M22.2X
ICD-10 code description
Patellofemoral disorders
Primary outcomes
1
Description
Perception of the pain intensity during squat on the affected limb
Timepoint
All intervention was allocated in a straight forward session and outcomes were measured.
Method of measurement
Participants were asked to indicate the intensity of the perceived pain on a 10 cm scale.
2
Description
Gait symmetry
Timepoint
All intervention was allocated in a straight forward session and outcomes were measured.
Method of measurement
Walking of participant was recorded using a motion capture system then parameters of the "gait symmetry" calculated and reported using a Visual 3D software.
3
Description
Speed of walking
Timepoint
All intervention was allocated in a straight forward session and outcomes were measured.
Method of measurement
Walking of participant was recorded using a motion capture system then parameters of the "walking velocity" calculated and reported using a Visual 3D software.
4
Description
Peak of the frontal moment at knee during gait
Timepoint
Peak of the frontal moment at knee during gait
Method of measurement
Walking of participant was recorded using a motion capture system then parameters of the "Peak frontal moment at the knee" calculated and reported using a Visual 3D software.
5
Description
Dynamic valgus angle during gait
Timepoint
All intervention was allocated in a straight forward session and outcomes were measured.
Method of measurement
Walking of participant was recorded using a motion capture system then parameters of the "Dynamic valgus angle during gait" calculated and reported using a Visual 3D software.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lateral wedge insole. This was a full-length insole made from poly-Vinyl acetate. The inclination of the insole in the frontal plan was 8 degrees for the affected limb and zero for the sound limb.
Category
Treatment - Devices
2
Description
Intervention group: Knee support. This was a neoprene knee support that supports the knee with four bilateral stays. This knee support was selected and fitted according to circumstance measurement of the knee.
Category
Treatment - Devices
3
Description
Intervention group: Lateral wedge insole and knee support together. The lateral wedge and knee support was used together for participants.
Category
Treatment - Devices
4
Description
Control group: no orthosis. Participants completed the tests without lateral wedge or knee support.