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IRCT20260201068723N1 IRCT 2026-02-16 Shahid Beheshti University of Medical Sciences Comparison of the effects of low-power and high-power lasers in the treatment of Bell's palsy Comparison of the Effectiveness of High-Intensity Laser Therapy (HPLT) and Low-Level Laser Therapy (LLLT) in the Management of Idiopathic facial nerve palsy (Bell’s palsy) 2026-02-20 anticipated 30 Recruiting https://irct.ir/trial/88931 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, after identifying eligible patients and obtaining written informed consent, patients are randomly assigned to one of three intervention groups: high-power laser, low-power laser, and placebo laser. Block randomization is used to randomly assign individuals. Randomization is performed in blocks of six with an allocation ratio of 1:1:1.In each block of six, two patients are assigned to each of the three study groups, but the order of patient allocation within each block is determined completely randomly. The unit of randomization in this study is the individual, and each patient is placed in one of the study groups independently and without knowledge of the group allocation of other patients. Stratified randomization is not used in this study.The random sequence is generated by SPSS statistical software and by an individual independent of the research team. After generating the random sequence based on blocks of six, the group allocations are placed in sealed and numbered envelopes in a sequential manner. These envelopes are opened in the order of patients entering the study and by the operator implementing the intervention. The principal investigator, patients, and outcome assessors remain blind to the type of intervention assigned until the end of data collection. Allocation concealment is achieved through the use of sealed and numbered consecutive envelopes. The envelopes and random sequence are prepared by an independent individual, Blinding description: Participants are unaware of the type of intervention they receive (high-power laser, low-power laser, or placebo laser). The placebo laser is identical to the real laser in terms of device appearance, sound, probe contact with the skin, and treatment duration, and does not emit any effective therapeutic radiation. All participants are informed of their participation in a clinical trial and the possibility of being assigned to each group before entering the study, and written informed consent is obtained from them. The principal investigator of the study is not involved in the process of assigning patients to groups and implementing the intervention, and remains blind to the type of intervention assigned to each patient. The randomization sequence and allocation envelopes are prepared by an individual independent of the research team. The laser interventions are performed by an operator who has no role in data collection or outcome assessment. The operator is aware of the type of laser treatment but does not intervene in the analysis of the results and assessment of the outcomes. The individuals responsible for collecting the data and assessing the clinical outcomes are blinded to the group allocation and have no knowledge of the type of intervention the patients received. The statistical analysis of the data is performed by a researcher who is unaware of the type of intervention each group received, and the groups are identified only by code. Individuals who participate in the preparation of the draft of the article remain blinded to the group allocation until the end of the statistical analysis. 2-3 Bell's palsy. Intervention 1: Intervention group: 10 patients with Bell's palsy will undergo 10 sessions of low-level laser treatment. Intervention 2: Intervention group2: 10 patients with Bell's palsy will undergo 10 sessions of high power laser treatment. Intervention 3: Intervention group3: 10 patients with Bell's palsy will receive 10 sessions of sham laser treatment. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals When: Access period starts after registration of results To whom: The data will be available to researchers working in academic and scientific institutions Conditions: In order to achieve a treatment protocol for Bell's palsy patients and reduce the damage caused by facial paralysis Where to obtain: emai:Mohammadrezasaadati1373@gmail.com How to obtain: After reviewing the request via email and providing the applicant's goals for the new study Comments:
public Mohammadreza Saadati
No.39, Isar 8 St, Isar Sq, Qom Town
Tehran Iran (Islamic Republic of) 3713189773 0098212707471 Mohammadrezasaadati1373@gmail.com Shahid Beheshti University of Medical Sciences scientific Fatemeh Hojjati
Darband St, Qods Sq, Tajrish St
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 fatemehojjati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 1. Age between 18 and 70 years old 2. Diagnosis of acute unilateral Bell's palsy within the past 10 days. The diagnosis must be made clinically and by ruling out other causes. 3. House-Brackmann scale score ≥3 at baseline 4. Receive standard drug treatment (corticosteroids ± antiviral drugs) 5. Ability and willingness to provide written informed consent 6. Possibility to attend follow-up meetings until the end 18 years 70 years Both 1. Facial palsy with a cause other than Bell's palsy, such as: stroke, tumors (such as acoustic neuroma), Lyme disease, Ramsey-Hunt syndrome, trauma or surgical injury 2. Previous history of Bell's palsy or facial nerve palsy on the same side 3. History of laser sensitivity or conditions that contraindications to laser use, such as: Photosensitive epilepsy, Use of photosensitizing medications 4. Open wound or active infection or skin disease in the treatment area 5. Presence of malignancy in the face or neck area 6. Pregnancy or breastfeeding 7. major chronic neurological diseases such as MS 8. Participation in other concurrent intervention studies 9. Starting physiotherapy or electrical stimulation before entering the study G51.0 Bell's palsy Rehabilitation Rehabilitation Placebo Intervention group: 10 patients with Bell's palsy will undergo 10 sessions of low-level laser treatment. Intervention group2: 10 patients with Bell's palsy will undergo 10 sessions of high power laser treatment. Intervention group3: 10 patients with Bell's palsy will receive 10 sessions of sham laser treatment. Facial Disability Index (FDI) score. Timepoint: Before starting laser therapy (time zero), immediately after the end of treatment with 10 laser sessions, and one month after the end of treatment. Method of measurement: A short, self-report questionnaire consisting of 10 items or questions. House-Brackmann system score. Timepoint: Before starting laser therapy (time zero), immediately after the end of treatment with 10 laser sessions, and one month after the end of treatment. Method of measurement: Evaluation of facial nerve function by physician's examination. Sunnybrook Facial Grading System score. Timepoint: Before starting laser therapy (time zero), immediately after the end of treatment with 10 laser sessions, and one month after the end of treatment. Method of measurement: Evaluation of facial nerve function by physician's examination. Electrodiagnostic test findings. Timepoint: Before starting laser therapy (time zero), immediately after the end of treatment with 10 laser sessions, and one month after the end of treatment. Method of measurement: Findings from muscle and nerve conduction studies. Shahid Beheshti University of Medical Sciences Approved 2026-01-19 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Shahid Arabi St, Yaman St, Shahid Chamran Highway, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)