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IRCT20220610055126N1 IRCT 2022-06-14 Shahid Beheshti University of Medical Sciences Comparing the effect of liquid phase concentrated growth factors with 2% lidocaine in the management of patients with myofascial pain syndrome Comparing the pain control effect of liquid phase concentrated growth factors with Lidocaine 2%, masseter and temporalis muscle trigger points and pain free mouth opening in patients with myofascial pain syndrome 2022-06-13 anticipated 16 Complete https://irct.ir/trial/64074 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of patients to two groups is done using the random block method and using excel 2021 software, Blinding description: Adjusting the follow-up time of patients so that they do not meet and talk in the waiting room and are not informed about the nature of the injectable substance in the opposite group (single blind). 3 patients with myofascial pain syndrome. Intervention 1: Intervention group: In this group of patients, we use LPCGF injection to control the pain of trigger points in one session. First we find the muscle trigger points in the master or temporalis muscle (this step is done by a specialist assistant under the supervision of the tutor in the examination room of the Oral and Maxillofacial Diseases Department). To find the trigger points, touch the muscle with medium to high pressure in all its parts. When a trigger point is found in a muscle that is actually like a relatively hard nodule to the touch, it causes a lot of pain in the patient that was determined to be the right touch; Then we disinfect the patient's skin with medical alcohol. Dot the trigger points with disinfected white cosmetic pencil and then take 10 ml of blood from the patient's vein (this step is done by a specialist assistant under the supervision of a competent nurse in the operating room of the gingival surgery ward). And pass into the white cap plastic tubes (Silfradent S.r.l, Sofia, Italy) without anticoagulants and additives (Figure 1). These tubes are centrifuged immediately using a fixed program device (Medifuge CGF; Silfradent S.r.l, Sofia, Italy) (Figure -2) (this step is performed by a specialist assistant under the supervision of a consultant in the operating room of the gingival surgery department. The exact settings of the centrifuge are as follows: 1. Acceleration for 30 seconds, 2-2700 rpm for 2 minutes, 3-2400 rpm for 4 minutes, 4-2700 rpm for 2 minutes, 5 Reduce the speed for 30 seconds and 6-Stop. At the end of the process, 3 parts of centrifuged blood are obtained: (Figure -3) 1. The upper layer contains platelet-poor plasma (PPP), 2- The middle layer They contain a very large and dense LPCGF, and the lower 3-layer contains red blood cells. As the test tubes do not contain anticoagulants, the injection should be given within 5 minutes. Otherwise, the blood clots and turns into a gel and LPCGF cannot be extracted. Therefore, after centrifugation, the middle layer (LPCGF) is removed within 5 minutes. The patient is then placed in the same examination position for injection. We inject the LPCGF produced by a 2ml syringe with a mesotherapy needle with a 30 gauge (AVA TEB, made in Iran). Hold each point of the trigger muscle on the surface of the skin between the thumb and forefinger or middle finger (whichever is more comfortable) and then insert the needle between the fingers perpendicular to the skin surface. The needle is inserted into the muscle until it enters the exact TrP, which is confirmed by the patient's reaction when reaching the trigger point. After the needle is inserted into each TrP, first aspiration is performed and then the LPCGF is slowly injected at a uniform rate for 60 seconds and then the needle is gently removed. Gum surgery is performed). In all patients, lidocaine 2% by 2ml syringe with needle Gage 30 mesotherapy (AVA TEB, made in Iran) is injected into other masticatory muscles if they are painful, so that in the medial trigeminal muscle, the injection site is near the junction of the muscle with the mandibular body and with external access and in the muscle. The lateral trigeminal is the injection site into the lower head of the muscle in the area of ​​the trigomandibular raphe with intraoral access. All patients in both intervention and control groups are advised to take 500 mg of acetaminophen orally in a maximum of two doses every 8 hours if necessary and 8 hours before the first follow-up session. We also recommend instructions and other forms of treatment strategies, such as a softer diet, changing postural habits, and reducing stress and anxiety in life. Intervention 2: Control group: In this group, similar to the intervention group, we mark the trigger points of the master and temporalis muscles and mark them with a white cosmetic pencil. Then, 1 ml of 2% lidocaine (5 ml vial) with a 2 ml syringe with mesotherapy needle with 30 gauge (AVA TEB, made in Iran), exactly similar to the injection method in the intervention group, after aspiration, 2% lidocaine into Mark the trigger points slowly, inject at a uniform speed for 60 seconds, and then gently remove the needle. Oral and maxillofacial diseases are performed. All injections are performed by a researcher. In both groups, on the day of injection (immediately before injection), VAS (from zero to 10) of each point is evaluated and averaged. Then, one, seven, fourteen and twenty-eight days after the injection (follow-up sessions), the VAS of each point is evaluated again and their mean is recorded. Follow-up time adjustment of patients is done in such a way that they do not meet and talk in the waiting room and are not informed about the nature of the injected substance in the opposite group (single blind). In all patients, lidocaine 2% by 2ml syringe with needle Gage 30 mesotherapy (AVA TEB, made in Iran) is injected into other masticatory muscles if they are painful, so that in the medial trigeminal muscle, the injection site is near the junction of the muscle with the mandibular body and with external access and in the muscle. The lateral trigeminal is the injection site into the lower head of the muscle in the area of ​​the trigomandibular raphe with intraoral access. All patients in both intervention and control groups are advised to take 500 mg of acetaminophen orally in a maximum of two doses every 8 hours if necessary and 8 hours before the first follow-up session. We also recommend instructions and other forms of treatment strategies, such as a softer diet, changing postural habits, and reducing stress and anxiety in life. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome or the like, can be shared. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: In order to conduct a review or meta-analysis. Where to obtain: Email, Fax How to obtain: 1 month Comments:
public Marzieh Alimohammadi
Shahid Chamran Highway, Evin, Daneshjoo Blvd., School of Dentistry, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5351 m.alimohamadi95@yahoo.com Shahid Beheshti University of Medical Sciences scientific Marzieh Alimohammadi
Shahid Chamran Highway, Evin, Daneshjoo Blvd., School of Dentistry, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5351 m.alimohamadi95@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age between 15 and 80 years [≥15 and ≤80] Presence of at least one trigger point in the masseter or temporalis muscle, previously detected Patient’s agreement for participation in this study. Presence of myofascial pain within masseter muscles according to the RDC/TMD (Ia and Ib) 15 years 80 years Both Patients being treated or addicted to painkillers and / or drugs that affect muscle function. Such as: muscle relaxants, anti-inflammatory, benzodiazepines Patients with mental disorders Patients with neuropathic pain and neurological disorders (trigeminal neuralgia) Patients with headache Edentulous patients Patients after radiotherapy Pregnancy or lactation Pain of dental origin Drug and/or alcohol addiction Patients with needle phobia Patients with bleeding disorders Metabolic (diabetes) and vascular diseases Treatment - Drugs Treatment - Drugs Intervention group: In this group of patients, we use LPCGF injection to control the pain of trigger points in one session. First we find the muscle trigger points in the master or temporalis muscle (this step is done by a specialist assistant under the supervision of the tutor in the examination room of the Oral and Maxillofacial Diseases Department). To find the trigger points, touch the muscle with medium to high pressure in all its parts. When a trigger point is found in a muscle that is actually like a relatively hard nodule to the touch, it causes a lot of pain in the patient that was determined to be the right touch; Then we disinfect the patient's skin with medical alcohol. Dot the trigger points with disinfected white cosmetic pencil and then take 10 ml of blood from the patient's vein (this step is done by a specialist assistant under the supervision of a competent nurse in the operating room of the gingival surgery ward). And pass into the white cap plastic tubes (Silfradent S.r.l, Sofia, Italy) without anticoagulants and additives (Figure 1). These tubes are centrifuged immediately using a fixed program device (Medifuge CGF; Silfradent S.r.l, Sofia, Italy) (Figure -2) (this step is performed by a specialist assistant under the supervision of a consultant in the operating room of the gingival surgery department. The exact settings of the centrifuge are as follows: 1. Acceleration for 30 seconds, 2-2700 rpm for 2 minutes, 3-2400 rpm for 4 minutes, 4-2700 rpm for 2 minutes, 5 Reduce the speed for 30 seconds and 6-Stop. At the end of the process, 3 parts of centrifuged blood are obtained: (Figure -3) 1. The upper layer contains platelet-poor plasma (PPP), 2- The middle layer They contain a very large and dense LPCGF, and the lower 3-layer contains red blood cells. As the test tubes do not contain anticoagulants, the injection should be given within 5 minutes. Otherwise, the blood clots and turns into a gel and LPCGF cannot be extracted. Therefore, after centrifugation, the middle layer (LPCGF) is removed within 5 minutes. The patient is then placed in the same examination position for injection. We inject the LPCGF produced by a 2ml syringe with a mesotherapy needle with a 30 gauge (AVA TEB, made in Iran). Hold each point of the trigger muscle on the surface of the skin between the thumb and forefinger or middle finger (whichever is more comfortable) and then insert the needle between the fingers perpendicular to the skin surface. The needle is inserted into the muscle until it enters the exact TrP, which is confirmed by the patient's reaction when reaching the trigger point. After the needle is inserted into each TrP, first aspiration is performed and then the LPCGF is slowly injected at a uniform rate for 60 seconds and then the needle is gently removed. Gum surgery is performed). In all patients, lidocaine 2% by 2ml syringe with needle Gage 30 mesotherapy (AVA TEB, made in Iran) is injected into other masticatory muscles if they are painful, so that in the medial trigeminal muscle, the injection site is near the junction of the muscle with the mandibular body and with external access and in the muscle. The lateral trigeminal is the injection site into the lower head of the muscle in the area of ​​the trigomandibular raphe with intraoral access. All patients in both intervention and control groups are advised to take 500 mg of acetaminophen orally in a maximum of two doses every 8 hours if necessary and 8 hours before the first follow-up session. We also recommend instructions and other forms of treatment strategies, such as a softer diet, changing postural habits, and reducing stress and anxiety in life. Control group: In this group, similar to the intervention group, we mark the trigger points of the master and temporalis muscles and mark them with a white cosmetic pencil. Then, 1 ml of 2% lidocaine (5 ml vial) with a 2 ml syringe with mesotherapy needle with 30 gauge (AVA TEB, made in Iran), exactly similar to the injection method in the intervention group, after aspiration, 2% lidocaine into Mark the trigger points slowly, inject at a uniform speed for 60 seconds, and then gently remove the needle. Oral and maxillofacial diseases are performed. All injections are performed by a researcher. In both groups, on the day of injection (immediately before injection), VAS (from zero to 10) of each point is evaluated and averaged. Then, one, seven, fourteen and twenty-eight days after the injection (follow-up sessions), the VAS of each point is evaluated again and their mean is recorded. Follow-up time adjustment of patients is done in such a way that they do not meet and talk in the waiting room and are not informed about the nature of the injected substance in the opposite group (single blind). In all patients, lidocaine 2% by 2ml syringe with needle Gage 30 mesotherapy (AVA TEB, made in Iran) is injected into other masticatory muscles if they are painful, so that in the medial trigeminal muscle, the injection site is near the junction of the muscle with the mandibular body and with external access and in the muscle. The lateral trigeminal is the injection site into the lower head of the muscle in the area of ​​the trigomandibular raphe with intraoral access. All patients in both intervention and control groups are advised to take 500 mg of acetaminophen orally in a maximum of two doses every 8 hours if necessary and 8 hours before the first follow-up session. We also recommend instructions and other forms of treatment strategies, such as a softer diet, changing postural habits, and reducing stress and anxiety in life. Pain intensity of masseter muscle trigger points, pain intensity of temporalis muscle trigger points, general pain intensity, painless opening of mouth. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 and 28 days. Method of measurement: Visual Analogue Scale for pain intensity and measurement with a graduated millimeter with an accuracy of one millimeter for maximum mouth opening. researcher(Marzieh Alimohammadi) Approved 2022-05-24 Ethics committee of Shahid Beheshti University of Medical Sciences Faculty of Dentistry, Shahid Beheshti University of Medical Sciences, Shahid Chamran Highway, Evin Tehran Tehran Iran (Islamic Republic of)