Protocol summary
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Study aim
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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.
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Design
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A clinical trial with a control group, double-blind, randomized, is performed on 120 patients. Block randomization is used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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1. Pain intensity 2. Disability index 3.Step down test 4.Knee range of motion
General information
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Reason for update
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The information of the start and end of sampling was not recorded correctly and it was corrected.
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Acronym
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patellofemoral pain syndrome (PFPS)
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IRCT registration information
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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
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Registration date
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2024-06-02, 1403/03/13
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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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2024-06-21, 1403/04/01
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Expected recruitment end date
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2024-12-20, 1403/09/30
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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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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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Public title
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effect of neurodynamic mobilization and dry needling technique in subjects 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:
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
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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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3
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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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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2024-02-08, 1402/11/19
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Ethics committee reference number
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IR.KMU.REC.1402.345
Health conditions studied
1
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Description of health condition studied
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patellofemoral pain syndrome
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ICD-10 code
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M25.56
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ICD-10 code description
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Pain in knee
Primary outcomes
1
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Description
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Pain intensity
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Timepoint
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Before, After and 1month follow up
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Method of measurement
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Visual analog scale
Secondary outcomes
1
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Description
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Knee disability index
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Timepoint
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Before, After and 1month follow up
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Method of measurement
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kujala questionnaire
2
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Description
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Step down test
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Timepoint
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Before, after and 1month follow up
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Method of measurement
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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
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Description
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Knee range of motion
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Timepoint
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Before, after and 1month follow up
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Method of measurement
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Goniometer
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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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.
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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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Kerman University of Medical Sciences
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Some of the data, such as information about the consequences, can be shared
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When the data will become available and for how long
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Starting the access period: 6 months after publition the results
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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Only statistical analyzes can be used to find treatment for improvement of patients
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From where data/document is obtainable
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Applicants can be guided by email to the authors(tahere.rezaiyan@gmail.com).
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What processes are involved for a request to access data/document
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First, they will email the authors of the study and we Will be answered within a week
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Comments
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