Randomized Double Blind Placebo Controlled Health And Social Care Essay

Abstract

The aim of the present study was to investigate the effect of LLLT and HILT and to compare their effects on the treatment of patients with Bell’s palsy. Only forth eight patients were participated and completed this study. Their age was (44 ± 15) years. They were randomly assigned into three groups. Group one (HILT), group two (LLLLT) and group three (Exercise group). All the study groups were treated with facial massage and exercises. HILT and LLLT groups were treated also with HILT and LLLT respectively. The grade of facial recovery was assessed by the facial disability scale (FDI) and the House-Brackmann Scale (HBS). Evaluation was carried after three and six weeks after treatment for all patients. Laser treatments included eight points on the affected side of the face three times a week for six successive weeks. FDI and HBS were used to assess the grade of recovery. Scores of both FDI and HBS were taken before, after three and six weeks. Friedman test and Wilcoxon-signed ranks test was used to compare the FDI and HBS scores within each group. The result showed that both HILT and LLLT were significant recovered patients with facial palsy. Moreover, HILT was more effective treatment modality as compared to LLLT and massage with exercises. It was concluded that Both HILT and LLLT were effective physical therapy modality which allows recovery from facial paralysis with an evidence of great effect of HILT more than LLLT.

Key words: HILT; LLLT; FDI; HBS; Bell’s palsy

Introduction

The face is considered to be psychologically the most important part of the body and an important component of self-concept [1]. Facial nerve paralysis is a common problem that affects facial appearance, and involves the paralysis of any structures innervated by the facial nerve [2]. Lesion of the facial nerve can result in partial or full paralysis of one side of the face with impaired facial movement [3] and diminished facial expression which interferes with interaction with others and face-to-face communications [2]. Patients with unilateral or bilateral facial paralysis have difficulties in eating, drinking, speaking which subsequently leads to impairment in the activities of daily living, social and psychological difficulties, including decreased self-esteem, anxiety, depression, and social isolation [1].

Facial paralysis can result from congenital, idiopathic, neoplastic, iatrogenic, infection, trauma, herpes zoster, tumors, and diabetes mellitus polyneuritis and other inflammatory causes [4]. When it occurs suddenly and of unknown cause, it is called Bell’s palsy [5]. It has annual incidence ranges between 23 to 35 cases for 100,000 people affecting both sexes mostly from 30 to 50 and 60 to 70 years old [6]. On physical examination, the patient is unable to raise the eyebrow or tightly close the eyelid on the affected side. The nasolabial fold is typically absent, and the mouth may be drawn toward the unaffected side. Patients may drool from the affected side because of inability to keep the mouth closed [7].

Electrotherapy, massage, facial exercises and biofeedback are different physical therapy modalities that have been used for the treatment of Bell’s palsy with concentration on the role of exercise therapy more than other interventions [5]. The aim of these modalities is to increase muscle and nerve function either through exercise or electrotherapy. Thermal methods and massage work by decreasing swelling and increasing blood flow to the affected tissues, increasing the amount of oxygen available to damaged, hypoxic tissues with the aim of promoting recovery [8].

Laser therapy is a modality that can be used in the treatment of Bell’s palsy. Laser considered a non-invasive, painless therapeutic modality which can be used for any type of patient including those who cannot use corticosteroids, such as diabetics and hypertensive patients [9].

Laser therapy has favourable prognosis in regeneration of peripheral nerves in both neurosensory and neuromotor deficits [10] such as trigeminal neuralgia, neuropathy, low back pain with sciatica, and herpes zoster [11]. Application of Laser produces both local and systemic effects which can enhance the nerve regeneration process [11]. Moreover, Laser improves recovery of the injured peripheral nerve and decreases posttraumatic retrograde degeneration of the neurons in the corresponding segments of the spinal cord [12].

Research studies showed that low level laser therapy (LLLT) increase the functional activity of the injured peripheral nerve, preservation of the functional activity of the injured nerve, prevention or decreased degeneration in corresponding motor neurons of the spinal cord, and improving the axonal growth and myelinisation [13].

Recently, High Intensity Laser Therapy (HILT) was introduced to the field of physical therapy and approved by FDA in 2004. The recent development of high power pulsed Nd:YAG laser (wavelength 1064 nm) which work with high peak powers and showed to induce a non-invasive regenerative therapy which able to reach and stimulate organs that are difficult to reach for classical lasers, such as the large and/or deep areas [14]. Recent studies described the anti-inflammatory, anti-oedemigenic and antalgic effects of Nd:YAG Laser, justifying its use in the therapy of pain and inflammation [15].

As mentioned, Laser affects tissues differently according to the wavelength, pulse duration, pulse/energy, energy density and delivery system. Researches in the laser dose response suggest that different wavelengths have specific penetration abilities and subsequent different effects [16, 17].

The limited number of studies – up to the available literature- which investigated the effect of laser therapy in either HILT or LLLT on treatment of Bell’s palsy and with the existence of new treatment modality such as HILT , there is still in need for further investigation for using laser therapy in the acute and chronic Bell’s palsy. So, the aim of the present study was to investigate the effect of LLLT and HILT and to compare their effects on the treatment of patients with Bell’s palsy.

Subjects and methods

Subjects

A total number of 52 patients had a facial palsy diagnosed with Bell’s palsy recruited from Al-Noor hospital, Makkah were participated in the study. Four patients were excluded from the study. The patients mean age was (43 ± 9.8) years. The inclusion criteria for patient selection were any patient who had unilateral Bell’s palsy whether right or left side [18]. Treatment started in sub-acute stage of illness after 3- 5 days after the acute onset subsided. We excluded patients who had central nervous system pathology, sensory loss over the face, recurrence of facial paralysis [19].

Power analysis:

When calculating a nonparametric test, we don't have to make any assumption about the distribution of the values as nonparametric tests are based on ranking values from low to high and we didn't know the shape of the underlying distribution. A useful rule-of-thumb were used in a nonparametric test to compute the sample size, it required to calculate it as in parametric test and add 15% to sample size [20]. A preliminary power analysis was applied with MNOVA –equivalent to non-parameter used- with power = 0.80, α = 0.05, expected effect size = 0.40 with a result of sample size of total 40 patients. The high effect size was recommended in order not to observe except the major difference between groups so; it yielded a realistic sample size and major observed differences in the variables measured [21].

Randomization

Patients were randomized into three groups. Each group had 17 patients. Randomization was performed simply by adding a specific identification number for each patient. These numbers were randomized by SPSS program into three groups. A randomized trial was used as the patients did not know in which group was assigned and which treatment would be taken. The therapists were blinded to the group assignment. Therefore, neither patients nor the therapist knew who was in which group.

Group one (HILT group) in which HILT and facial massage and facial expression exercises were used. Group two (LLLT group) which treated by LLLT and facial massage and facial expression exercises. Group three (exercise group) treated by facial massage and facial expression exercises plus sham laser. Four patients were excluded or withdrawal from the study. One patient was excluded after baseline evaluation because facial palsy was accompanied with hemiplegia. Two patients from LLLT group and one from exercise group were withdrawal because they did not follow the scheduled treatment sessions as shown in flow chart (1).

All patients were given a full explanation of the treatment protocol and a written informed consent form to sign their agreement for participation in the study and publication of the results. The study was approved by the departmental council of the Physical Therapy Department, Faculty of applied Medical Science, Umm Al-Qura University, Makkah.

Evaluation of facial recovery

To assess the grade of recovery, the facial disability scale (FDI) and the House-Brackmann Scale (HBS) were used. Facial Disability Index was developed by Van Swearingen and Brach, (1996) to enhance the assessment of facial neuromuscular dysfunction. Beyond the impairment domain, this index provides a reliable measurement, with construct validity for evaluating the patients with facial nerve disorders [22]. This questionnaire has ten items that evaluate patients’ physical and social aspects (mastication, deglutition, communication, labial mobility, emotional alterations and social integration). It uses a 100-point scale, with higher scores indicating less impairment and handicap [3].

House–Brackmann Scale was classified as a universal scale by the American Academy of Otolaryngology Committee of Disorders of the Facial Nerve. It was proposed and modified by House and Brackmann in 1985 [3]. Since then, the HBS has extended to be the most accepted scale in assessment of facial nerve palsy because of its ease of use, and clinical sensitivity [23]. This scale analyzed the symmetry, synkinesis, stiffness and global mobility of the face. [3]. It is divided into six categories (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction and total paralysis) with grade one representing normal facial function in all areas and grade six representing total paralysis [3]. Patients’ evaluation scores of FDI and HBS were collected from all patients before treatment, after three, and six weeks.

HILT

A HILT group received HILT treatment with a neodymium YAG laser (Nd:YAG) pulsated waveform, produced by HIRO 3 device (ASA, Arcugnano,Vicenza, Italy). The apparatus provided the following options: (Nd:YAG), with pulsed emission (1064 nm), very high peak powers (3 KW), high levels of fluency (energy density) ( 810-1780 mJ/cm), brief duration (120-150 us), low frequency (10-40 Hz), Duty Cycle of about 0.1% [14].

HILT was used with energy density of 610 mJ/cm2, frequency of 3 Hz. HLLT was applied with contact and perpendicular over on the superficial roots of the facial nerve on the affected side (Figure 2). The time of application was 7 second/ per point with energy of 10 J/point. The total energy delivered to the patient during one session was 80 joules. The device calculates the number of pulses, energy received to each session and the total energy delivered to the patient during the treatment session. HILT was applied for a total of 18 treatment sessions over a period of six consecutive weeks (three sessions/ week). Facial massage and facial expression exercises in front of the mirror were performed after each session for all patients.

LLLT

Gallium-aluminum-Arsenide diode (GaAs) laser (BTL-5000 laser) infrared probes of 830 nm wavelength and 100 mW output power, average energy density of 10J/cm2, frequency of 1KHz and duty cycle 80%. In all cases, the laser in direct contact with the superficial roots of the facial nerve on the affected side (Figure 2) with time of application 2 min and 05 sec per point for 8 points [24] and total energy of 80 Joules. LLLT was applied for a total of 18 treatment sessions over a period of six consecutive weeks (three sessions/ week). Facial massage and facial expression exercises in front of the mirror were performed after each session for all patients. Calibration of laser equipment was done by the manufacture company through the thermopile power meter.

Exercises

Facial massage and facial expression exercises were carried out for all patients, including simple facial expression exercises, active graduated strengthening exercises in front of mirror (active assisted, free and resisted), proprioceptive neuromuscular facilitation exercises for facial muscles and resisted exercises for neck muscles [19]. Patients in exercise group received a sham laser before massage for three minutes. Participants were taught to do massage and exercises correctly by the physiotherapist. All treatment groups were given instruction to repeat massage and exercises two times a day at least for 6 weeks. A family member confirmed that the participant carried out the massage and exercises.

Outcome measures

To assess the grade of recovery, FDI and HBS were used. Scores of both FDI and HBS were taken before, after 3 and six weeks.

Statistical analysis

Analyses of data were performed using SPSS for Windows, version 16, except for the sample size and power calculations that were performed with G-Power 3.1 for windows. Friedman test and Wilcoxon-signed ranks test was used to compare the FDI and HBS scores within each group. Difference between baseline and post-treatment scale scores for each group was computed by friedman test. Willcoxon Signed Ranked test was performed to compare between each pre-treatment, after three weeks and after six weeks of measurements. Kruskal-Wallis test and Mann-Whitney U-test was used to compare the scores between the groups. The difference between treatment-groups in FDI and HBS was performed by Kruskal Wallis test. Mann-Whitney test was used to compare between the same measurements intervals (3 weeks, 6 weeks) in groups in case of significance. The level of statistical significance is set as P<0.05.

Results

One way analysis of variance was used to compare among the patients’ age in the treatment groups and showed that there was no significant difference between patients’ age among the treatment groups as the f value was 0.144 and p value was 0.86 with a mean age of 43.82±10.36 for HILT group, 43.26±10.06 for the LILT group, and 45.12±9.35 for the exercise group.

Friedman test and Wilcoxon-signed ranks test showed statistical improvement after three weeks and after six weeks of the treatment in the HBS and in the components of FDI scores within each group with the greatest improvement found after six weeks (table 1 and 2). Kruskal-Wallis test revealed no significant difference between the treatment groups in the HBS and FDI scores before treatment. After three weeks of the treatment, Kruskal-Wallis test showed significant difference between the treatment groups in the HBS and FDI score (table 1).

The Mann-Whitney U-Test revealed that the greatest improvement in the components of FDI scores occurred in HILT group followed by LLLT group treated with the LILT group and the least improvement was in exercises group as shown in table 3. While for the HBS scores, the best effect was obtained in the HILT group and there was no significant difference between LLLT group and exercise group after three weeks (table 3).

Analysis of the HBS and FDI scores with Mann-Whitney U-test after six weeks of the treatment showed significant difference between the treatment groups in the HBS and FDI scores (table 1). Moreover, it was found that the greatest effect was in HILT group followed by LLLT group and the least effect was found in the exercise group (table 3).

Discussion

This study was conducted to investigate the effect of HILT , LLLT and to compare their effects on the treatment of patients with Bell’s palsy. The main findings in the present study were that both HILT and LLLT were significant treatment modalities for recovering patients with facial palsy. Moreover, HILT was more effective treatment modality as compared to LLLT and massage with exercises. However, there was a lack of knowledge due to limited number of studies investigating the effects of HILT in treatment of patients with facial palsy. In the present study, treatment starting after 3-5 days in sub-acute stage and the results were obtained after three sessions / week over a period of 6 consecutive weeks in patients diagnosed with facial palsy.

In the same line with the present study, Bernal, [24] mentioned that LLLT is an excellent complementary medium for the recovery of facial paralysis, an excellent and painless therapeutic alternative without side-effects which can be used for any type of patient, including those who cannot use corticosteroids, such as diabetics and hypertensive patients [24]. Also, Ladalardo et al; [10] studied the effect of GaAs diode laser on patients with Bell’s palsy. The outcome measures used was the HBS. Patient showed functional improvement ranging between one and three grades on the HBS [10].

In spite of many applications in humans, the biomodulative effect of low level laser therapy has still not been completely understood. One of the possible explanations of laser effect, that Laser affects the mitochondrial respiratory chain by increasing the activity of certain enzymes such as cytochrome oxidase and adenosine triphosphatase (ATP) [25] and increase in ATP production in mitochondria [26]. It increases DNA synthesis, collagen and pro-collagen production [27].

The anti-inflammatory effect of Laser therapy can be caused by a reduction in the levels of pro-inflammatory cytokines such as interleukin-1 alpha (IL-1 alpha), interleukin-1 beta (IL-1 beta), and also an increase in the levels of anti-inflammatory growth factors and cytokines such as basic fibroblast growth factor, platelet-derived growth factor, transforming growth factor-beta (TGF-beta). In addition, laser irradiation causes dilatation of blood vessels, which also leads to a reduction in swelling caused by inflammation [28]. It may also have inhibitory effects on the release of prostaglandins, cytokine levels and cyclooxygenase (Cox) 2 and it may accelerate cell proliferation, collagen synthesis and tissue repair [29,30].

Regarding to nerve fibers, LLLT may have a direct effect on nerve structures, which could increase the speed of recovery of the conductive block or inhibit A-d and C fiber transmission [31]. Also, it was reported that LLLT radiation significantly widens the arterial and capillary vessels, increases microcirculation, activates angiogenesis, reduces swelling caused by inflammation, and stimulates immunological processes and nerve regeneration [32-34].

The spectrum of visible to infrared light, in which the wavelength of HILT belongs, can cause stimulation as well as inhibition of various organisms [35]. HILT quickly reduces inflammation and painful symptoms [36]. High power pulsed Nd:YAG laser considered a non-invasive regenerative therapy with a non-painful and non-invasive therapeutic system which work with high peak powers (3KW) and a particular waveform with (λ = 1046 nm) with regular peaks of elevated values of amplitude and low duty cycle in order not to reach the thermal tissue threshold and to decrease the thermal accumulation phenomena, and being able to penetrate the deep tissue with photothermal, photochemical and photomechanical effects that increase blood flow, vascular permeability and cell metabolism [14,26].

With a lack of knowledge due to limited numbers of studies about HILT, it was mentioned that HILT causes minor and slow light absorption by melanin and Hbo2 chromophores [14]. This absorption increases the mitochondrial oxidative reaction and ATP, RNA, or DNA production (photochemistry effects) and resulting in the phenomenon of tissue stimulation (photobiology effects) [37].

Some preliminary studies found that HILT seems to be more effective than LLLT, due to its higher intensity and to the depth reached by the laser ray [14, 38, 39]. Also, it was mentioned that the laser effectiveness depends on factors such as wavelength, site, duration, and dose treatment as well as depth of target tissue. Research into the dose response profile of laser therapy suggests that different wavelengths have specific penetration abilities through human skin [16, 17].

It was mentioned that number of patients with facial palsy have a spontaneous clinical recovery, but about one-fifth of cases are left with sequelae [40]. In Bell’s palsy, spontaneous complete recovery was found in about 69% of the patients [41]. Therefore, about 31% of BP patients who did not receive the appropriate treatment may suffer from incomplete recovery with residual facial muscle weakness with or without one or more of the commonly encountered complications e.g. synkinesis, hyperkinesis and/or contracture. The latter might cause secondary psychological sequels [40].

There are no rules regarding to this illness and the spontaneous recovery should not be expected for a patient even though the literature reefers to 70% recovery within two weeks, because it is precisely this 30 % which does not recover spontaneously with traditional medicines and therapies, that will retain a notable consequence of their paralysis, and that might have had a total recovery if they receive complementary treatment with laser within 15 days [24]. Therefore, it was considered that the laser must be taken into account as an excellent physical complementary therapy which allows recovery from facial paralysis, diminishing the possibility of side-effects due to corticosteroids, the actual results of the paralysis which are handled only with traditional therapy and above all, the possibility of applying it to patients who cannot use corticosteroids. It also allows for the recovery in a noticeable manner.

The recovery of the present study was evaluated by FDI and HBS. Although these questionnaires considered as a valid and reliable measurement [22], the electrophysiological measurements may be needed for supporting these finding in the future research.

Conclusion

Laser therapy was effective physical therapy modality which allows recovery from facial paralysis. Both HILT and LLLT was effective more than facial massage and exercises only with an evidence of great effect of HILT more than LLLT.

Recommendation

Laser therapy has been shown to be effective in recovery from facial paralysis. HILT or LLLT are effective physical therapy tools that could be used separately or in combination with facial massage and exercises in rehabilitation of patients with facial palsy.

Funding

This research received no specific grant from any funding agency in the public, commercial, or non-profit sectors.

Conflict of interest

There is no financial and personal relationship with other people or organizations that could inappropriately influence this work.

Acknowledgements

The authors would like to express their appreciation to all subjects participated in this study with all content and cooperation and special thanks to our colleagues at the Department of Physical Therapy , Faculty of Applied Medical Science , Umm AL-Qura University, Saudia Arabia.