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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 30  |  Issue : 4  |  Page : 349-354

Efficacy of therapeutic ultrasound with soft tissue mobilization in patients of oral submucous fibrosis


1 Department of Oral Medicine and Radiology, Inderprastha Dental College, Ghaziabad, UP, India
2 Department of Oral Medicine and Radiology, ITS Dental College Greater Noida, Muradnagar, UP, India
3 Department of Oral Medicine and Radiology, ITS Dental College, Muradnagar, UP, India
4 EKOHUM Foundation, India
5 Oral Pathology, ITS Dental College, Muradnagar, UP, India

Date of Submission14-Aug-2018
Date of Acceptance18-Sep-2018
Date of Web Publication17-Jan-2019

Correspondence Address:
Dr. Himani Tyagi
16-B/201 Vasundhara Avas Vikas Colony, Ghaziabad, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jiaomr.jiaomr_142_18

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   Abstract 


Aims: To study the effect of adjuvant therapeutic ultrasound with soft tissue mobilization in the management of patients suffering from oral submucous fibrosis (OSMF). Settings and Design: This study was conducted on OSMF patients visiting the outpatient department of Oral Medicine and Radiology, ITS-CDSR, Muradnagar, Ghaziabad, in collaboration with Physiotherapy Department ITS CDSR. Materials and Methods: Thirty patients diagnosed clinically and histopathologically with OSMF were enrolled in the study. They were divided into two groups consisting 15 patients each in group A and group B.Both A and B groups were given lycopene (12mg/day) and intralesional (I/L) injection (biweekly) for 3 months. Therapeutic ultrasound with soft tissue mobilization was used only in group B. Statistical Analysis Used: An independent t-test was done for intergroup comparison for group 1 and group 2. Results: Two groups show that the difference in the treatment in both the group was highly significant at >0.01 to very highly significant at 0.001. Itshowsthat in group A, the effect is steady, and in group B, the effect is substantialwithin the first 15 days; nevertheless, the total clinical effect after 3 months is similar in both the groups. Conclusions: Therapeutic ultrasound when used as an adjuvant shows a significant improvement in the patient's condition with no reported side effects. Hence, should be incorporated in the treatment protocol for patients with OSMF.

Keywords: Intralesional, oral submucous fibrosis, ultrasound


How to cite this article:
Tyagi H, Lakhanpal M, Dhillon M, Baduni A, Goel A, Banga A. Efficacy of therapeutic ultrasound with soft tissue mobilization in patients of oral submucous fibrosis. J Indian Acad Oral Med Radiol 2018;30:349-54

How to cite this URL:
Tyagi H, Lakhanpal M, Dhillon M, Baduni A, Goel A, Banga A. Efficacy of therapeutic ultrasound with soft tissue mobilization in patients of oral submucous fibrosis. J Indian Acad Oral Med Radiol [serial online] 2018 [cited 2019 Apr 21];30:349-54. Available from: http://www.jiaomr.in/text.asp?2018/30/4/349/250250




   Introduction Top


Oral submucous fibrosis (OSMF) is a chronic insidious scarring disease of oral cavity, characterized by progressive inability to open the mouth due to loss of elasticity and development of fibrous bands in labial, buccal mucosa, soft palate, lip mucosa, and anterior pillar of the fauces. Infrequently, it affects the lining of pharyngeal box or vocal cords/upper part of esophagus and is capable of involving the  Eustachian tube More Details, thereby, causing relative loss of auditory acuity.[1],[2],[3]

OSMF still remains enigmatic as the multifactorial model for pathogenesis such as consumption of chilies, areca nut, iron and nutritional deficiencies, tobacco, lime, genetic abnormalities, altered salivary constituents, herpes simplex virus, human papilloma virus, and autoimmunity has been postulated to have their direct and indirect effects in OSMF. Most important risk factor is chewing betel quid and this has been supported by epidemiological, case control, animal trial and tissue culture studies as well. Also, it has been a part of religious, social, and cultural rituals.

There is no definitive treatment for OSMF. Owing to its multifactorial etiology and pathogenesis, various modalities are tried over years, but no single drug has provided complete relief from symptoms of OSMF. Evaluation of the merits and disadvantages of individual items in management is not possible owing to the use of combined treatment protocols, which is inevitable at present because of the empirical nature of each approach. Many methods use physiotherapy as an adjuvant therapy.

Therapeutic ultrasound has been used extensively in physical medicine with considerable success. The objectives of ultrasound treatment are to accelerate healing, increase the extensibility of collagen fibers, and provide pain relief. Kneading is an effective form of massage therapy in improving the elasticity of fibrous tissues and mobilizing scar tissues.[4],[5] The gentle soft tissue manipulation is broadly used in physiotherapy for improving their extensibility.

The effect of ultrasound has been studied in OSMF as an adjuvant to the conventional modalities. In literature, there are very few studies signifying the role of therapeutic ultrasound in OSMF and this still remains a hidden field which needs to be explored further. Hence, this study is designed to evaluate the adjuvant effects of therapeutic ultrasound and physiotherapy in OSMF patients. The pathogenesis complexity of the disease process dictates the need for multimodality therapy.


   Materials and Methods Top


This study was conducted on OSMF patients visiting the outpatient department of Oral Medicine and Radiology, ITS-CDSR, Muradnagar, Ghaziabad, in collaboration with Physiotherapy Department ITS CDSR. Thirty patients (between age group 20 and 40 years) with clinically diagnosed oral submucous fibrosis and fulfilling the inclusion criteria of Maximal Mouth Opening <30mm accompanied with burning sensation on eating spicy foods were enrolled in the study. Presence of any other disease that mimics OSMF such as systemic sclerosis, tetany, patients with any history of radiotherapy, history of medicinal or surgical treatment for OSMF, and presence of other systemic disease (screened by medical history/questionnaire) were excluded from the study.

The institutional ethical committee clearance was obtained before start of the study. A written informed consent was taken from all subject included in this study. According to the software-generated sequence, the patients selected for study after carrying exclusion and inclusion criteria were allocated into one of the groups A and B.

Group A consists of 15 OSMF patients who were administered I/L injection of triamcinolone acetonide + I/L injection of hyalase (biweekly) and lycopene 12 mg/day for 3 months.[6],[7],[8]

Group B consists of 15 OSMF patients who were administeredI/L injection of triamcinolone acetonide + I/L injection of hyalase (biweekly) + lycopene 12 mg/day for 3 months + therapeutic ultrasound and soft tissue mobilization.

1. ForI/LInjection:[8]

Site selection: Area with maximum numbers of bands

Areas for local injection submucosal: buccal mucosa, outer aspects of soft palate, pterygomandibularraphae, and circumoral bands (if any).

  • Inj. Triamcinaloneacetonide (kenakort) - 10 mg/mL, inject 0.1 cc/1 cm lesion twice a week
  • Inj. Hyalase- 1,500 I.U. dissolved in 2 c.c. of 2% lignocaine.


After the I/Linjection, patients of group B were subjected tosoft tissue mobilization and ultrasound therapy: ultrasound and physiotherapy sittings were scheduled continuously for 15 consecutive days with a day off each week. During the study, all the patients were treated with the same calibrated ultrasound equipment [Figure 1].
Figure 1: (a) Therapeutic ultrasound given to patient. (b) Therapeutic ultrasound given to patient. (c) Fingertip and thumb kneading

Click here to view


2. For ultrasound therapy protocol- ultrasound at an average

Intensity 1.5 W/cm2 continuous 1:1 duty cycles

Frequency 3 MHz

Time 6 min using a sound head back and forth in the template at a speed of ~4cm/s to each side involved over the area of fibrosis.

3. For soft tissue mobilization protocol-

  1. Fingertip and thumb tip kneading in combination would be performed by grasping the buccal mucosa with thumb placed outside and index finger inside for 3 min within tolerable pain limits
  2. Wide mouth opening and maintaining it for 5 s- 10 repetitions
  3. Lateral deviation of mandible to right and left side- 10 repetitions
  4. Protrusion of mandible- 10 repetitions
  5. Gradual mouth stretching by placing the left thumb over the upper incisor and right index finger over the lower incisor and maintaining it for 5 s- 10 repetition.



   Results Top


In total, 30 patients diagnosed clinically and histopathologically with OSMF, fulfilling the inclusion criteria of the study, were randomly allocated in group A and group B with 15 patients in each group. Statistical analysis was done using SPSS Version 19 and for intraobserver variability independent t-test was applied.

Mouth opening ranged between 7 and 30 mm. The mean mouth opening in group A was 19.80 mm, whereas in group 2, it was 19.25 mm. Tongue protrusion ranged between 15 and 40 mm. The mean tongue protrusion in group A was 24.55 mm, whereas in group 2, it was 25.50 mm. Cheek flexibility on right and left side ranged between 1 and 1.3 cm. The mean cheek flexibility in group A was 1.033 mm and in group B was 1.053 mm.

It was observed that the frequency of appearance of fibrous bands was more over retromolarraphae and mid-buccal mucosa followed by anterior buccal mucosa. Out of 30 patients, 28 (93.24%) reported burning sensation on consuming hot and spicy food. Only two patients reported with no burning sensation. Mean of burning sensation in group A was 7.2 on VAS scale. Mean of burning sensation in group B was 8.6.

Effects of treatment given to both group A and group B are stated below:

Effect on mouth opening

The three readings on mouth opening in group A and group B do not showany significant difference, from P value, showing that the results of mouth opening in each group are independent of each other. On the other hand, the difference at baseline to 15 days, baseline to 3 months, and 15 days to 3 months shows that the difference is statistically significant at 0.05 levels. The difference also shows that the difference in mouth opening in group B is more than group A. The difference between mouth opening in 15 days to 3 months is not high suggestive that the maximum difference in mouth opening is achieved in first 15 days of treatment protocol as shown in [Table 1].
Table 1: The effect of treatment on the mouth opening in group 1 and group 2

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Effect on tongue protrusion

[Table 2] shows similar statistical details for tongue protrusion at baseline to 15 days and after 3months. The values are different than the mouth opening, but the pattern of the resultant was similar to mouth opening. At the end of 3 months, the difference between the two groups is minimal and statistically insignificant. The significant P value at baseline to 15 days is 0.002, whereas from 15 days to 3 months, it is 0.017. This shows that there is a significant difference, but the significance is less between 15 days and 3 months.
Table 2: The effect of treatment on the tongue protrusion in group 1 and group 2

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Effect on cheek flexibility

[Table 3] shows the difference in the cheek flexibility using the same parameters of timing. The table shows a significant difference in the first 15 days and between 15 days and 3 months similar to tongue protrusion. The difference between baseline and 3 months is not significant, suggesting that after 3months, both the treatment show equal effectiveness.
Table 3: The effect of treatment on the cheek flexibility in group 1 and group 2

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Effect on burning sensation

[Table 4] shows the difference in the burning sensation using the same parameters of timing. The difference between baseline and 3 months is not significant suggesting that after 3months both the treatment shows equal effectiveness.
Table 4: The effect of treatment on the burning sensation in group 1 and group 2

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   Discussion Top


This study was conducted over a period of 2 years, wherein the study population including a total of 30 patients out of which 70%(21) were males and 30%(9) were females. They were divided into two groups, one experimental group with 15 patients and one control group having another 15 patients with clinically and histopathologically diagnosed OSMF. A higher incidence of male predilection has been reported in literature by Lai et al.[9] (1995), Merchant AT et al.[10] (1997), and Kumar et al.[2] (2006).[3] Majority of patients in this study were in the age group of 25–35 years. All patients in this study gave a positive history of areca nut chewing in the raw form as betel nut proper or as in the form of a commercial preparations (such as Dilbaag, Kuber, Rajdarbaar) called ghutka or pan masala, which was proven to be a major contributing agent of OSMF. This was also reported by Canniff et al.[11] in their article on pathogenesis and management of OSMF. Similar results were found by the study done by Kumar A et al.[2] Thus, it supports the association of areca nut with OSMF, suggesting its etiological role in causation of the disease.[12],[13],[14]

Overall, 30 patients in the study had blanching of buccal mucosa bilaterally, whereas only one reported with unilateral involvement, which shows the prevalence of bilateral blanching of buccal mucosa in OSMF patients.

The mean mouth opening before giving any treatment in group A was 19.80 mm, whereas in group B, mean mouth opening was 19.25 mm. The improvement was analyzed and showed that after treatment, the difference in mouth opening in group B is more than in group A. On comparing, the improvement in mouth opening from baseline to 3 months and 15 days to 3 months is not high suggesting that the maximum difference in mouth opening is achieved during the first 15 days of treatment protocol. There was high significant improvement in mouth opening in first 15 days in group B as compared with group A [Figure 2] and [Figure 3], which was in accordance with studies done by Pooja et al.[15] (2010), Vijaykumar[4] (2013), Subramanium et al.[16] (2014). This rapid improvement in group B in first 15 days is attributed to the therapeutic effect of ultrasound, which works on creating the extensibility of collagen fibers and to reduce inflammation, thereby promoting healing. Kneading and soft tissue mobilization is an effective form of massage therapy in improving the elasticity of fibrous tissues and mobilizing scar tissues, which increases the blood flow to the area, thus, holistically aiding in repair and regeneration of the tissue.[17] The tongue protrusion showed significant improvement, but the pattern of the resultant was similar to mouth opening. The tongue protrusion improves predominantly in first 15 days. At the end of 3 months, the difference between the two groups is minimal and statistically insignificant. Additionally, the tongue exercises such as straight tongue stretch, side tongue stretch, up and down stretch, tongue sweep, and pushing the tongue against the inside of the cheek were done for coordinating and strengthening the muscle activity. Due to the force being continuously and broadly distributed, patients are able to exercise with minimal discomfort. Instructing tongue exercises regime helped in maintaining the post-therapeutic tongue protrusion.
Figure 2: Pre and post treatment photographs of the patients in group 1 at baseline, at 15th day and after 3 months respectively, Fig 1, Fig 4, Fig 2, Pre and post treatment photographs of the patients in group 2 at baseline, at 15th day and after 3 months respectively, Fig 6, Fig 3, Fig 5

Click here to view
Figure 3: Graph 1: The mean increase in mouth opening between the two groups when compared from baseline till 15th day, baseline to 3 months, 15th day to 3 months. Graph 2: The mean increase in tongue protrusion between the two groups when compared from baseline till 15th day, baseline to 3 months, 15th day to 3 months. Graph 3: The mean increase in cheek flexibility between the two groups when compared from baseline till 15th day, baseline to 3 months, 15th day to 3 months. Graph 4: The mean decrease in burning sensation between the two groups when compared from baseline till 15th day, baseline to 3 months, 15th day to 3 months

Click here to view


The cheek flexibility shows a significant difference in the first 15 days and between 15 days to 3 months, similar to the tongue protrusion. The difference between baseline and 3 months is not significant, suggesting that after 3 months, both the treatments show equal effectiveness.

The mean improvement in burning sensation was better in group B as compared with group A. However, the difference is statistically not significant. This was similar to a study carried out by Kumar et al.[2] (2007), which showed similar pattern of improvement.

Result of the study after 2 years was same as attained after 3 months as we checked all the parameters whenever the patient comes for routine checkup as advised.

There is a disadvantage of this ultrasound therapy as it presents a risk of periosteal burning/pain, since it causes differential heating at tissue interfaces.[17] However, in the study, there were no reported cases of such side effects. In this study, both A and B groups were given lycopene and I/L injection (biweekly) for 3 months. Only the therapeutic ultrasound with soft tissue mobilization was used in group B. In both the groups, at 3 months, the results were almost same and there was no significant difference in all the variables. Like previous studies, the combination therapy and I/L injections have shown effective results, but rapid improvement in group B in the initial 15 days has been obtained by administrating therapeutic ultrasound as an adjuvant therapy.[5],[6],[18] The rapid improvement helps in patient motivation and compliance for the treatment completion.

Therapeutic effects obtained by ultrasonic energy are due to increased vascular and fluid circulation, increase in cell permeability, and increase in pain threshold and a break in pain cycle. The physiological effects of ultrasound may induce thermal and nonthermal physical effects in tissues. Thermal effects (continuous mode) are those that are due to heating and may include increased blood flow, reduction in muscle spasm, increased collagen fibers extensibility, and proinflammatory response. In the cases of OSMF, we want more of thermal effects, so continuous mode is advisable for treatment. Also, the ultrasound is a deep heating modality, wherein, at an intramuscular depth of 3 cm, a 10-min hot pack treatment yielded an increase of 0.8°C, whereas at the same depth, 1-MHz ultrasound has raised muscle temperature nearly 4°C in 10 min. At 1 cm below the fat surface, a 4-min warm whirlpool (40.6°C) raised the temperature 1.1°C. However, at the same depth, 3-MHz ultrasound raised the temperature 4°C in 4 min.[19]

Collectively, with a cessation of the betel quid chewing habit, these treatment regimens combined with daily mouth opening exercises were found to be necessary to manage OSMF cases in early and advanced stages of progression. A multidisciplinary palliative care approach is the need of the hour for OSMF patients developing severe trismus refractory to conventional medical and surgical treatment. Therapeutic ultrasound proves to be an effective adjuvant along with combination therapy in patients of OSMF.

Summary and Conclusion

Mean improvement in all variables at the end of 3 months was almost same in both the groups. The treatment effect in group B, in which therapeutic ultrasound was given, showed dramatic effects in the initial period on all the parameters, such as that ofmouth opening, tongue protrusion, cheek flexibility, and burning sensation. So, a conclusion can be drawn that

  1. Therapeutic ultrasound should be given as an adjuvant therapy in OSMF patients
  2. Patient motivation and compliance to treatment are increased with ultrasound therapy
  3. The long-term effect with I/L injection and lycopene, which is current mode of treatment, should be continued.


Therapeutic ultrasound when used as an adjuvant shows a significant improvement in the patients' condition with no reported side effects, hence, should be incorporated in the treatment protocol for patients with OSMF.

Limitations

  1. Alternatively, our results should be reevaluated using a different study design, wherein one group, ultrasound is given, and in the other, traditional I/L injections and lycopene combination therapy is given
  2. A study would be planned in which therapeutic ultrasound should be used on the right cheek and I/L injection on the left cheek
  3. Another study involving a larger sample size would be ideal and also staging of OSMF would have revealed better results.


Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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