The effect of lumbopelvic manipulation on Electromyography parameters of gluteus medius and vastus medialis in patients with patellofemoral pain syndrome
The effect of lumbopelvic manipulation on electromyography parameters of gluteus medius and vastus medialis in patients with patellofemoral pain syndrome
Design
A concealed, randomized, double blinded, controlled Clinical trial design of 26 patients.
permuted block method was used for randomization
Settings and conduct
This study is performed in the biomechanics laboratory of Babol University of Medical Sciences.After the patient's presence in laboratory, the examining physiotherapist performs an evaluation and electromyography(EMG).
the lumboplevic manipulation is performed by a physiotherapist who specializes in this area.The specialist physiotherapist performs lumboplevic or sham-manipulation for the patient according to the randomization table. After the intervention and after resting the patient for 10 minutes, the examining physiotherapist enters the laboratory again, and while he is not aware of the type of intervention performed by the treating physiotherapist, the initial evaluation, tests and EMG are performed in the same way. Also, after one week, the examiner will follow up on the patients' condition by phone.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients under 40 years of age with anterior knee pain with no history of trauma and with patellofemoral pain syndrome diagnostic criteria
exclusion criteria: History of any pathological injury in the knee, lumbopelvic manipulation Contraindications, Taking painkillers or physiotherapy in the last 72 hours
Intervention groups
The subjects are divided into two groups and An intervention session is performed for them .for the first group The lumboplevic manipulation is performed. And for the second group, the sham manipulation is performed.
Main outcome variables
Electromyography parameters of gluteus medius and vastus medialis muscles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200818048446N1
Registration date:2021-09-11, 1400/06/20
Registration timing:retrospective
Last update:2021-09-11, 1400/06/20
Update count:0
Registration date
2021-09-11, 1400/06/20
Registrant information
Name
khodabakhsh javanshir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
kjavanshir@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-05, 1399/07/14
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lumbopelvic manipulation on Electromyography parameters of gluteus medius and vastus medialis in patients with patellofemoral pain syndrome
Public title
The effect of lumbopelvic manipulation on patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients if they are aged less than 40 years
unilateral anterior knee pain or a pain on palpation of patellar facets provoked by at least two of these activities:ascending/descending stairs, squatting, prolonged sitting, jumping, kneeling and Isometric quadriceps contraction
positive sign in patellar apprehension test and/or eccentric step down test and/or vastus medialis coordination test
a pain level of at least 3 points and maximum 8 points on the numerical pain rating scale(NPRS) during resisted knee extension
knee disability level between 45 and 70 based on the Kujala patellofemoral questionnaire (KPQ)
Have at least 3 of the 5 criteria to predict treatment success, including the following: The difference in the active range of motion of the internal rotation of the hip between the two limbs is more than 14 degrees- Dorsiflex active range of motion of the foot is more than 16 degrees- No stiffnes after sitting for more than 20 minutes- Navicular drop- Squatting is most painful activity
Exclusion criteria:
a history of knee or spine surgery
dislocation or fracturein pelvic
meniscal lesion
patellar subluxation/dislocation
evidenceof tendinopathy or ligamentous pathologies
neurologic disorders
patients who had previously received physiotherapy treatment orused analgesic drugs within 72 h prior to the experiment
osteoporosis with documented compression fracture
severe lumbosacral nerveroot compression signs
pregnancy
systemic disease or connective tissue disorders
Lumbar disc rupture: extrusion, sequestration
Serious spinal lesions include rheumatoid arthritis, tumors, vascular lesions of the spine, etc.
spondylolisthesis and Specified lumbar instabilities
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants are randomly divided into two groups by block randomization method with a fixed size of each block of 4.In this way, the list of random shifts of 4 letters A and B, which represent groups one and two, is generated with Random Allocation software and is the criterion for assigning individuals in groups. For example, if ABBA permutation is generated in the first block, it indicates that the first person is in group A, the second and third person in group B, and the fourth person in group A.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study, In the way that evaluation and treatment are done by two different people And the evaluator is not aware of the type of grouping. Statistical analysis is also performed by a third person who do not know the grouping and treatment process.
Patient blindness: Patients are told that manual therapy is to be performed on the lumbar, pelvic, and lower extremities, But they do not know the exact location and how. Patients are also not informed in which group they are. In the placebo(control) group, the patient is placed on a supine position and the therapist stands on the opposite side of the involved knee, The patient then locks the fingers behind her/his head and then passively moved to the side bend position by the therapist and rotated to the healthy position , and is in this position for five seconds. In the treatment group, the same steps are followed, with the difference that in the last stage, the thrust (High-speed movement of the therapist hand on the patient's ASIS) is applied. Patients are given time to participate in the project in such a way that they will not have any contact to share experiences.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2020-08-16, 1399/05/26
Ethics committee reference number
IR.MUBABOL.REC.1399.248
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
onset of electromyography activity of vastus medialis muscle
Timepoint
Before and immediately after the intervention
Method of measurement
Surface electromyography device
2
Description
onset of electromyography activity of Gluteus medius muscle
Timepoint
Before and immediately after the intervention
Method of measurement
Surface electromyography device
3
Description
amplitude of electromyography activity of vastus medialis muscle
Timepoint
Before and immediately after the intervention
Method of measurement
Surface electromyography device
4
Description
amplitude of electromyography activity of Gluteus medius muscle
Timepoint
Before and immediately after the intervention
Method of measurement
Surface electromyography device
Secondary outcomes
1
Description
pain Intensity
Timepoint
Before, immediately after and one week after the intervention
Method of measurement
Numeric Pain Rating Scale
2
Description
Physical function
Timepoint
Before and immediately after the intervention
Method of measurement
step down test
3
Description
Knee joint functional level
Timepoint
Before, immediately and one week after the intervention
Method of measurement
Using kujala questionnaire
Intervention groups
1
Description
Intervention group: one session lumbopelvic manipulation: The patient was positioned supine while interlocking the fingers behind the head and the elbows are in contact with each other in the front.The patient's torso is in a neutral position and the therapist is on the patient's healthy side,then the patient was passively side-bent towards and rotated away from the painful knee.Stabilizer hand, Fix the patient's arms on the bed and The moving hand fix on the anterior superior iliac spine where the knee is involved. After getting loose, it applies a sudden thrust in the posterior-external-inferior direction. This technique is given in one session and then evaluated immediately and information is recorded.
Category
Rehabilitation
2
Description
Control group: one session sham manipulation: The patient is placed in the position of true lumboplevic manipulation for 5 seconds, But the technique is not applied. After giving the position of the technique, the information is recorded.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahyanejad Hospital
Full name of responsible person
Khodabakhsh Javanshir
Street address
Mostafa Khomeini St, Modares St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3222 3594
Fax
+98 11 3222 5035
Email
yahyanejad@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghdimi
Street address
Babol University of Medical Sciences, Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Tahere Zafarian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences, Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
t.zafarian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences, Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
kjavanshir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Tahere Zafarian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences, Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
t.zafarian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available