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)

The effectiveness of high-power laser therapy , low-power laser therapy on improving physical function, quality of life, facial palsy severity, and nerve conduction in patients with Bell's palsy

A randomized, double-blind, controlled clinical trial on 30 patients with Bell's palsy.

Patients with acute Bell's palsy diagnosed by neurologists from 3 hospitals are referred to the Shohada Center after starting standard treatment and after obtaining informed consent are randomly assigned to three groups: HPLT treatment, LLLT treatment, and sham laser treatment. Before starting laser therapy (time zero), patients evaluated using the questionnaires, and a conduction study will be taken from the facial nerve. Subsequently, 10 sessions of laser therapy (every other day) will be performed. For follow-up, immediately after the end of treatment and one month later, patients will be evaluated again using the questionnaires and edx evaluation, and will be analyzed.

Inclusion criteria: Age 18-70 years, acute unilateral Bell's palsy within the past 10 days, Beckman score ≥3 at base, standard drug therapy informed consent. Exclusion criteria: palsy other than Bell's, previous history of Bells , history of laser sensitivity or conditions that contraindications, malignancy, pregnancy or lactation, chronic neurological diseases, physiotherapy before study

Patients in high-power and low-power laser groups will receive 10 sessions of laser therapy. In the placebo group, patients will lie on a bed for 10 sessions and be positioned in exactly the same location as the laser therapy groups but no laser radiation will be applied.

effectiveness of HPLT and LLLT on improving physical function, quality of life, facial paralysis severity, and nerve conduction in patients with Bell's palsy

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.

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.

All data can be shared after de-identifying individuals

Access period starts after registration of results

The data will be available to researchers working in academic and scientific institutions

In order to achieve a treatment protocol for Bell's palsy patients and reduce the damage caused by facial paralysis

emai:Mohammadrezasaadati1373@gmail.com

After reviewing the request via email and providing the applicant's goals for the new study