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
Comparison of the Effects of Sensorimotor Training versus Hip, Knee & Trunk Strengthening Exercise on Pain & Function of Patients with Patello Femoral Pain Syndrome.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Intervention group 1: Sensorimotor exercise
Intervention group 2: strengthening exercise(Hip, Knee & Trunk)
Main outcome variables
Pain, Function, Strength, Balance
General information
Reason for update
Acronym
PFPS
IRCT registration information
IRCT registration number:IRCT20151118025105N5
Registration date:2019-08-01, 1398/05/10
Registration timing:registered_while_recruiting
Last update:2019-08-01, 1398/05/10
Update count:1
Registration date
2019-08-01, 1398/05/10
Registrant information
Name
Sobhan Sobhani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71136271551
Email address
sobhanis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Comparison of the Effects of Sensorimotor Training versus Hip، Knee & Trunk Strengthening Exercise on patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor as well as data analyzer will be blinded to the group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Rehabilitation Sciences School
Street address
School of Rehabilitation Sciences, Abiverdi 1 Street, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
33669-71947
Approval date
2019-03-18, 1397/12/27
Ethics committee reference number
IR.sums.rehab.rec.1397.026
Health conditions studied
1
Description of health condition studied
patellofemoral pain syndrome
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders
Primary outcomes
1
Description
Pain
Timepoint
Pre and post intervention (after 4 weeks) and during follow up (after 4 weeks)
Method of measurement
Anterior Knee Pain Scale
2
Description
Function
Timepoint
Pre and post intervention (after 4 weeks)
Method of measurement
Step Down Test
Secondary outcomes
1
Description
Hip and Knee muscle strength(knee extensor+ hip abductor and external rotator)-Trunk flexor- Trunk extensor
Timepoint
Pre and post intervention (after 4 weeks)
Method of measurement
Hand Held Dynamometer
2
Description
Balance
Timepoint
Pre and post intervention (after 4 weeks)
Method of measurement
Modified Star Excursion Balance Test
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinics in Shiraz city
Full name of responsible person
Sobhan Sobhani
Street address
School of Rehabilitation Sciences, Abiverdi 1 Street, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1552
Fax
+98 71 3627 1552
Email
sobhanis@sums.ac.ir
Web page address
http://rehab.sums.ac.ir/fa/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ghasemi Unes
Street address
Floor 7, Center Bilding of Shiraz Univercity of Medical Science, beside Helale Ahmar, Zand street