Efficacy of Multiwave Locked System Laser on Recovery of Patients With Bell's Palsy: A Randomized Placebo Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Facial disability scale (FDI)
研究概览
简要总结
Background: Idiopathic Bell's palsy (IBP) is a unilateral facial paralysis of sudden onset and unknown etiology. Patient with IBP has an impaired facial expressions and psychological affection, which interfere with social communication. Multiwave locked system (MLS) laser therapy is a class IV laser with synchronizes emission of an 808 nm continuous laser and a 905 nm pulsed laser. It is proposed that MLS facilitates greater penetration and therapeutic effects than low-level laser therapy (LLLT).
Aims: The aim of present study is to investigate the effect of MLS laser in the treatment of patients with unilateral IBP.
Participant: A total number of 60 patients with IBP will be recruited from Makkah hospitals. Treatment will begin in the subacute phase as they referred from neuro-doctors. All the recruited patients will be randomly assigned into three groups of 20 patients each.
Intervention: All patients will be treated with facial massage and exercises. In addition, group one will receive MLS laser with 10 J/cm2 in scanning mode while the group two will receive 10J/point for eight points.
Measured variables: Facial disability scale (FDI) and House-Brackmann scale HBS will used to assess the grade of facial nerve recovery. The scores of both questionnaires will be collected at the baseline, after three and six weeks after treatment.
Statistical Analysis: The Friedman and Wilcoxon signed ranks tests will be used to compare the FDI and HBS scores within each group
详细描述
Multi-wave locked system (MLS) laser therapy had been presented in the arena of rehabilitation and attained interests of numerous researchers due to its unique features. MLS laser is a Class IV, high-power laser, which is characterized by a combination of two waveforms of continuous emissions of an 808 nm wavelength and a pulsed 905 nm emitted in synchrony. MLS used recently in research and revealed significant reduction of musculoskeletal pain and disability. Researchers recommend its use in case of muscle lesions and/or diseases. No proved way was shown to use laser in the treatment of facial palsy in either scanning the affected side or applying laser to specific motor points.
It was proposed that the combination of the dual laser waveforms offers better penetrability and outcomes on than ordinary lasers and help in recovery of facial muscle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
By sealed envelopes, the allocation concealment will be achieved. Patient randomization is performed simply by computer number generator for each patient using GraphPad software. All eligible participants will be evaluated by independent physician and will be treated by the same therapist. The physician conducts the processes of participant enrollment, and allocation. The same assessors will measure the measured outcome. Both the therapist and the assessor will be blinded (masked) from patient's enrollment into the three study groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient who has unilateral IBP either on the right or left side.
- •Treatment will begin in the sub-acute stage of illness 3-5 days after the acute onset subsided.
- •patients will accept to attend to the physical therapy department to receive their corresponding treatment twice a week for successive six weeks.
排除标准
- •Patients who have central nervous system pathology
- •sensory loss over the face, or recurrence of BP.
- •Patients with upper motor facial nerve palsy will be also excluded.
- •Any infant or child (≤18 years) with BP will be also excluded.
- •Chronic facial palsy patients
- •Patients BP having after a tumor, stroke, and Lyme disease will be excluded.
研究组 & 干预措施
Scanning Gorup
Patients in this group will receive facial massage, facial expression exercises and a Multiwave Locked System Laser with energy density 10 J/cm2. Laser will scan the affected side after calculating the distance and the total energy delivered to the one side of the face.
The average treatment area is 50 cm2. The energy density was 10 J/cm2 with a total energy of 500 J and the treatment time is approximately 15 minutes. The laser probe will be away from the eye region. Both patients and therapist wear a laser googles.
干预措施: Photobiomodulation therapy (laser therapy) (Other)
Scanning Gorup
Patients in this group will receive facial massage, facial expression exercises and a Multiwave Locked System Laser with energy density 10 J/cm2. Laser will scan the affected side after calculating the distance and the total energy delivered to the one side of the face.
The average treatment area is 50 cm2. The energy density was 10 J/cm2 with a total energy of 500 J and the treatment time is approximately 15 minutes. The laser probe will be away from the eye region. Both patients and therapist wear a laser googles.
干预措施: Facial massage and facial expression exercises (Other)
Point laser Group
Patients in this group will received facial massage, facial expression exercises and laser at predetermined eight points on the affected side of the facial muscles. the hand piece is positioned perpendicular to 8 points which is located on the superficial roots of the facial nerve of the affected side. Each point will receive an energy density of 10 J/point with total energy delivered to the patient during one session of 80 joules. The time of application 90 sec/point. laser is calibrated by the manufacture company before the starting the experiment and periodically during the sessions. The laser probe will be away from the eye region. Both patients and therapist wear a laser googles.
干预措施: Photobiomodulation therapy (laser therapy) (Other)
Point laser Group
Patients in this group will received facial massage, facial expression exercises and laser at predetermined eight points on the affected side of the facial muscles. the hand piece is positioned perpendicular to 8 points which is located on the superficial roots of the facial nerve of the affected side. Each point will receive an energy density of 10 J/point with total energy delivered to the patient during one session of 80 joules. The time of application 90 sec/point. laser is calibrated by the manufacture company before the starting the experiment and periodically during the sessions. The laser probe will be away from the eye region. Both patients and therapist wear a laser googles.
干预措施: Facial massage and facial expression exercises (Other)
Control Group
patients in this group will receive only facial massage, facial expression exercises and placebo laser. Facial expression exercises include active graduated strengthening exercises in front of a mirror (active assisted, freedom, and resisted), proprioceptive neuromuscular facilitation exercises for facial muscles, and resisted exercises for neck muscles. Participants are taught to perform massage and exercises correctly by the physiotherapist. All treatment groups are given instruction to repeat the massage and exercises two times a day for at least 6 weeks. The patient or one of his/her family members will confirm that the participant carries out the massage and exercises at home.
干预措施: Facial massage and facial expression exercises (Other)
结局指标
主要结局
Facial disability scale (FDI)
时间窗: The scores of the questionnaire will be collected after six weeks after treatment.
The FDI was produced by Van Swearingen and Brach to improve the assessment of facial neuromuscular dysfunction. Beyond the impairment domain, this index provides a reliable measurement with construct validity for evaluating patients with facial nerve disorders.
Facial disability scale (FDI)
时间窗: The scores of the questionnaire will be collected at the baseline before treatment.
The FDI was produced by Van Swearingen and Brach to improve the assessment of facial neuromuscular dysfunction. Beyond the impairment domain, this index provides a reliable measurement with construct validity for evaluating patients with facial nerve disorders.
Facial disability scale (FDI)
时间窗: The scores of the questionnaire will be collected after three weeks after treatment.
The FDI was produced by Van Swearingen and Brach to improve the assessment of facial neuromuscular dysfunction. Beyond the impairment domain, this index provides a reliable measurement with construct validity for evaluating patients with facial nerve disorders.
次要结局
- House-Brackmann scale (HBS)(The scores of the questionnaire will be collected at the baseline before starting of the treatment)
- House-Brackmann scale HBS(The scores of the questionnaire will be collected after six weeks after treatment.)
- House-Brackmann scale HBS(The scores of the questionnaire will be collected after three weeks after treatment.)
研究者
Mohamed Alayat
Associate Professor of Physical Therapy
Umm Al-Qura University