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IRCT20230620058541N1 IRCT 2023-08-01 Babol University of Medical Sciences "The effect of femoral nerve neurodynamic technique on pain and functional disability in patients with patellofemoral pain syndrome" "Investigation of the effect of adding femoral nerve neurodynamic technique to routine physiotherapy treatment compared to routine physiotherapy treatment alone, on pain and functional disability of patients with patellofemoral pain syndrome" 2023-07-01 anticipated 66 Complete https://irct.ir/trial/70806 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block random allocation method was designed by an epidemiologist using WWW.Sealedenvelop.com. The number of considered blocks is 6. The list of random allocation of patients will only be at the disposal of the plan's epidemiologist. To hide the random allocation process, the order of the treatments is written on 84 cardboard cards that are the identification number of the corresponding treatment and only the project methodologist will be aware of the corresponding code. The cards are placed in envelopes (the envelopes are thick and it is not possible to see from the back of the envelope). When the therapist declares the eligibility of a patient, the methodologist will provide the patient with the treatment package. The person evaluating the intended outcomes is a third person who is unaware of the randomization process and the type of treatment performed. To analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used, Blinding description: After the participants enter the study, they are given a general explanation of the study process. Due to the single-blind design of the study, the participants are blinded to receiving the relevant intervention type. Since the implementation of neurodynamic techniques is similar to the implementation of the muscle stretching technique and both groups benefit from the implementation of the muscle stretching technique, it is not possible to differentiate the technique by the participants. Also, in this study, the person analyzing the results is blind to the type of treatment and does not know the type of treatment of the patients. N/A Patellofemoral Pain Syndrome. Intervention 1: Control group: This group of patients only receives the usual physiotherapy treatment, which includes: 1. Electrotherapy: To reduce pain, a 4-channel conventional tennis device with a frequency of 60-120 Hz and a diversion of 20-60 microseconds is used. 2. Therapeutic exercise: includes strengthening and stretching exercises. Stretching: Stretching exercises include stretching the hamstrings, gastrosoleus, iliotibial band, and quadriceps muscles. Each stretching exercise is performed 3 times and the stretching position is maintained for 30 seconds each time. Strengthening with a specific dose is performed by the patient. 1) isometric quadriceps contraction in the supine position (2 times a day, 20 repetitions each time) 2) SLR (2 times a day, 10 repetitions each time) 3) knee extension in the sitting position (2 times) 5 repetitions per day (4) Hip abduction in a standing position (2 times a day, 5 repetitions each time) 5) External rotation of the hip in a standing position (2 times a day, 5 repetitions each time) Strengthening exercise of the first session, only quadriceps isometric contraction In the second session, a set of SLR and knee extension is added in the sitting position, in the third session, a set of hip abduction and external rotation exercises is added, and from the fourth session onwards, the patient has prescribed a complete set of exercises. The intervention is carried out in 10 sessions (5 days a week) and after that, the studied variables, i.e. pain intensity, functional disability, and range of motion of hip extension are measured again during the neurodynamic technique. Intervention 2: Intervention group: This group of patients, after receiving the usual physiotherapy treatment that was completely given in the control group, will also receive the neurodynamic technique of the femoral nerve as follows. To perform the neurodynamic technique: 1. The nerve stretching movement is used, including stretching along the entire length of the nerve path, which tries to apply tension along the entire nerve axis. In the case of the femoral slump technique, head, neck, and trunk flexion and hip extension (nerve tension) are in the neutral position of head, neck and trunk, and hip flexion. 2. The movement of sliding the nerve along its bed without stretching the nerve. Regarding the femoral slump technique, it is done in two ways: Proximal sliding is a position where the patient's hip is kept in flexion, and the patient's head, neck, and trunk are flexed and returned to the neutral position. Distal sliding, maintaining the head, neck, and trunk extension position, we take the patient's hip to the extension position and return to the neutral position again. The neurodynamic techniques of the femoral nerve are performed in 3 sets of 10 with 10 seconds of rest between sets. The onset of symptoms of people is in the form of reports of neurogenic pain (sharp pain and tingling) in the buttock and front of the thigh. The intervention is carried out in 10 sessions (5 days a week) and after that, the studied variables, i.e. pain intensity, functional disability, and range of motion of hip extension are measured again during the neurodynamic technique. Yes - There is a plan to make this available What will be shared: All data related to participants in the plan can be shared after de-identification. When: The access period starts after the results are printed To whom: All individuals are allowed to access the data for research purposes. Conditions: The data can be accessed for research purposes by sending an email to the responsible author. Where to obtain: To receive data, please use the postal address r.gerami@mubabol.ac.ir or phone number 01132194641 and the address Keshavarz Blvd., Babol University of Medical Sciences. How to obtain: To receive information, it is enough to send the reason for the need to access the data to the first author's email, or call 01132194641, or visit Keshavarz Blvd., Babol University of Medical Sciences. Comments:
public Gerami Romina
Babol University of Medical Sciences, Keshavars boulevard
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4641 r.gerami@mubabol.ac.ir Babol University of Medical Sciences scientific Maryam Abbaszadeh -Amirdehi
Babol University of Medical sciences, Keshavars boulevard
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4641 maryam_Abbasszadeh@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Being between 18 and 45 years old Worsening of symptoms in at least two of the following: squatting, going up and down stairs, kneeling, or sitting for long periods. Positive at least two tests: Clark, compression test, and active patellar grind 18 years 45 years Both Having specific injuries in the meniscus or ligaments of the knee History of lower limb or spine surgery Having limited range of motion in the spine, knee, or hip Having hypermobile joints (score above 4 on the Beighton scale) Having acute back pain (root L2/L3/L4) Malignancies Having a systemic disease such as rheumatic disease Report severe pain more than 7.4 on the VAS scale Rehabilitation Rehabilitation Control group: This group of patients only receives the usual physiotherapy treatment, which includes: 1. Electrotherapy: To reduce pain, a 4-channel conventional tennis device with a frequency of 60-120 Hz and a diversion of 20-60 microseconds is used. 2. Therapeutic exercise: includes strengthening and stretching exercises. Stretching: Stretching exercises include stretching the hamstrings, gastrosoleus, iliotibial band, and quadriceps muscles. Each stretching exercise is performed 3 times and the stretching position is maintained for 30 seconds each time. Strengthening with a specific dose is performed by the patient. 1) isometric quadriceps contraction in the supine position (2 times a day, 20 repetitions each time) 2) SLR (2 times a day, 10 repetitions each time) 3) knee extension in the sitting position (2 times) 5 repetitions per day (4) Hip abduction in a standing position (2 times a day, 5 repetitions each time) 5) External rotation of the hip in a standing position (2 times a day, 5 repetitions each time) Strengthening exercise of the first session, only quadriceps isometric contraction In the second session, a set of SLR and knee extension is added in the sitting position, in the third session, a set of hip abduction and external rotation exercises is added, and from the fourth session onwards, the patient has prescribed a complete set of exercises. The intervention is carried out in 10 sessions (5 days a week) and after that, the studied variables, i.e. pain intensity, functional disability, and range of motion of hip extension are measured again during the neurodynamic technique. Intervention group: This group of patients, after receiving the usual physiotherapy treatment that was completely given in the control group, will also receive the neurodynamic technique of the femoral nerve as follows. To perform the neurodynamic technique: 1. The nerve stretching movement is used, including stretching along the entire length of the nerve path, which tries to apply tension along the entire nerve axis. In the case of the femoral slump technique, head, neck, and trunk flexion and hip extension (nerve tension) are in the neutral position of head, neck and trunk, and hip flexion. 2. The movement of sliding the nerve along its bed without stretching the nerve. Regarding the femoral slump technique, it is done in two ways: Proximal sliding is a position where the patient's hip is kept in flexion, and the patient's head, neck, and trunk are flexed and returned to the neutral position. Distal sliding, maintaining the head, neck, and trunk extension position, we take the patient's hip to the extension position and return to the neutral position again. The neurodynamic techniques of the femoral nerve are performed in 3 sets of 10 with 10 seconds of rest between sets. The onset of symptoms of people is in the form of reports of neurogenic pain (sharp pain and tingling) in the buttock and front of the thigh. The intervention is carried out in 10 sessions (5 days a week) and after that, the studied variables, i.e. pain intensity, functional disability, and range of motion of hip extension are measured again during the neurodynamic technique. Pain intensity of patients with patellofemoral pain syndrome. Timepoint: The beginning of the study (before the start of the intervention) and the end of the intervention (at the end of the 10th session). Method of measurement: Visual Analogue Scale. Functional disability of patients with patellofemoral pain syndrome. Timepoint: The beginning of the study (before the start of the intervention) and the end of the intervention (the end of the 10th session). Method of measurement: Kujula's 13-question questionnaire. Hip extension range in the slump position of patients with patellofemoral pain syndrome. Timepoint: The beginning of the study (before the start of the intervention) and the end of the intervention (the end of the 10th session). Method of measurement: Goniometer. Babol University of Medical Sciences Approved 2023-06-19 Ethics committe of Babol University of Medical Sciences Babol University of Medical Sciences, Keshavars boulevard Babol Mazandaran Iran (Islamic Republic of)