Comparison of the effect of neurodynamic mobilization and dry needling technique on the pain, function, and range of motion in subjects with patellofemoral pain syndrome
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General information
2024-04-20, 1403/02/01
2024-06-21, 1403/04/01
2024-0406-2021 00:00:00
2024-09-20, 1403/06/30
2024-12-20, 1403/09/30
2024-0912-20 00:00:00
empty
The information of the start and end of sampling was not recorded correctly and it was corrected.
The information of the start and end of sampling was not recorded correctly and it was corrected.
empty
اطلاعات شروع و پایان نمونه گیری به درستی ثبت نشده بود و آن اصلاح شد.
اطلاعات شروع و پایان نمونه گیری به درستی ثبت نشده بود و آن اصلاح شد.
Protocol summary
Study aim
The present study is designed to investigate the effect of neurodynamic mobilization techniques and dry needling on pain, function and knee range of motion in patients with patellofemoral syndrome.
Design
A clinical trial with a control group, double-blind, randomized, is performed on 120 patients. Block randomization is used for randomization.
Settings and conduct
Subjects are assigned to four groups of control, DN and Neurodynamic, and a combination of these two techniques according to block randomization. The two-blind study will be conducted in such a way that people are assigned to groups and patients are evaluated by people who are unaware.
Participants/Inclusion and exclusion criteria
All participants are between 18 and 40 years old and have a clinical diagnosis of patellofemoral syndrome. Clark's test is positive in these patients and the pain is in one knee. There are constant pain for at least the last 4 weeks. Also, they have trigger points in the gluteus medius and quadriceps muscles on the same side and quadratus lumborum on the opposite side. People are excluded from the study if they have a history of previous knee surgery, any knee pathology (meniscal tear, patella tendinopathy, ligament sprain and osteoarthritis), any systemic disease and/or connective tissue disorders.
Intervention groups
Dry needling (DN): It is used on the trigger point in the lumbar and knee muscles. The needle is applied for three sessions with an interval of one day. Neurodynamic technique: The technique of neurodynamic mobilization of the femoral nerve is performed in two tension and slide modes three sessions a week for two weeks. Control group: After the trigger points are determined, the therapist applied soft and superficial massage on the involved muscles.
Main outcome variables
1. Pain intensity 2. Disability index 3.Step down test 4.Knee range of motion
General information
Reason for update
The information of the start and end of sampling was not recorded correctly and it was corrected.
Acronym
patellofemoral pain syndrome (PFPS)
IRCT registration information
IRCT registration number:IRCT20240211060958N2
Registration date:2024-06-02, 1403/03/13
Registration timing:prospective
Last update:2024-08-02, 1403/05/12
Update count:1
Registration date
2024-06-02, 1403/03/13
Registrant information
Name
tahereh rezaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5367
Email address
tahere.rezaiyan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of neurodynamic mobilization and dry needling technique on the pain, function, and range of motion in subjects with patellofemoral pain syndrome
Public title
effect of neurodynamic mobilization and dry needling technique in subjects with patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All participants are aged from 18 to 40 years
Having a clinical diagnosis of patellofemoral syndrome.
Complaints of pain in the anterior of the knee or around the patella on the affected side are determined during at least 3 of the following activities: squatting, step up and down from stairs, running, prolonged sitting, and kneeling.
Positive Clark test
Unilateral pain in one knee
having constant pain for at least the last 4 weeks and the average pain in the last week is more than 3 according to the NPRS scale.
The present of trigger points in the gluteus medius and quadriceps muscles on the same side and quadratus lumborum on the opposite side.
Exclusion criteria:
History of previous knee surgery
Any knee pathology (meniscus tear, patella tendinopathy, ligament sprain and osteoarthritis)
Any systemic diseases and/or connective tissue disorders
People who have received acupuncture, injections, or dry needling treatment for knee in the past 6 months.
Pregnant women
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: A table of random numbers is used. Participants are given a number and using the table of random numbers. Therapist randomly starts from a table point in the row or column direction. The therapist can close his eyes and choose a point.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind study will be done ,in this way, the assessment of patients are done by people who are unaware of the status of the grouping of patients. Treatment is provided by a specialist physiotherapist and evaluated by a collaborator.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the kerman University of Medical Sciences
Street address
Haft Bagh Square, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2024-02-08, 1402/11/19
Ethics committee reference number
IR.KMU.REC.1402.345
Health conditions studied
1
Description of health condition studied
patellofemoral pain syndrome
ICD-10 code
M25.56
ICD-10 code description
Pain in knee
Primary outcomes
1
Description
Pain intensity
Timepoint
Before, After and 1month follow up
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Knee disability index
Timepoint
Before, After and 1month follow up
Method of measurement
kujala questionnaire
2
Description
Step down test
Timepoint
Before, after and 1month follow up
Method of measurement
Functional test: Participants are asked to stand on the step with their injured foot, try to touch the ground with the opposite heel, and then return to their original position.
3
Description
Knee range of motion
Timepoint
Before, after and 1month follow up
Method of measurement
Goniometer
Intervention groups
1
Description
Intervention group: Dry needling. The treatment is done in 3 sessions with an interval of one day. The muscles selected for dry needling in this study are practically important in the management of patellofemoral syndrome, including: quadratus lumborum, gluteus medius, iliopsoas, rectus femoris, vastus medialis, and vastus lateralis.
Category
Rehabilitation
2
Description
Intervention group: Neuromobilization of femoral nerve The patient is placed in a sidelying position on the side of the healthy leg. The lower limb on the healthy side is placed at 90 degrees of hip flexion and knee flexion. The lower limb of the affected side is placed in a neutral hip position, and the trunk is in a straight position and the head is in a neutral position. The therapist stands behind the patient at the level of the pelvis so that the pelvis does not move forward or backward. Then we ask the patient to actively move neck and trunk flexion, knee extension to neck and trunk extension, knee flexion.
Category
Rehabilitation
3
Description
Control group: Placebo While the patient is supine position, the therapist applies soft and superficial massage on the involved muscles. The fingertips of each therapist's hand are placed in contact with the related muscles and a surface massage is performed. The number of sessions is the same as the dry needling group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers affiliated to Kerman University of Medical Sciences
Full name of responsible person
Majid Ashraf Ganjavi
Street address
Tehran Road, under the railway bridge, Red Crescent Street
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3212 4962
Email
tahere.rezaiyan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
The beginning of Haft Bagh Alavi axis, Kerman University of Medical Sciences campus
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
a.iranpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
tahereh rezaeian
Position
Assistant Professor of Kerman University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
The beginning of Haft Bagh Alavi axis, Kerman University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
tahere.rezaiyan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
tahereh rezaeian
Position
Assistant Professor of Kerman University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
The beginning of Haft Bagh Alavi axis, Kerman University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
tahere.rezaiyan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
tahereh rezaeian
Position
Assistant Professor of Kerman University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
The beginning of Haft Bagh Alavi Square, Kerman University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
tahere.rezaiyan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some of the data, such as information about the consequences, can be shared
When the data will become available and for how long
Starting the access period: 6 months after publition the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Only statistical analyzes can be used to find treatment for improvement of patients
From where data/document is obtainable
Applicants can be guided by email to the authors(tahere.rezaiyan@gmail.com).
What processes are involved for a request to access data/document
First, they will email the authors of the study and we Will be answered within a week