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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 31  |  Issue : 1  |  Page : 29-35

Comparison of conventional pharmacological therapy and holistic approaches (Naturopathy and Yoga) in the management of chronic orofacial pain: A randomized controlled study


Department of Oral Medicine and Radiology, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, Meerut, Uttar Pradesh, India

Date of Submission04-Jan-2019
Date of Acceptance11-Feb-2019
Date of Web Publication23-Apr-2019

Correspondence Address:
Dr. Khushboo Bhalla
Department of Oral Medicine and Radiology, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, Meerut, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jiaomr.jiaomr_3_19

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   Abstract 


Background: Orofacial pain disorders and their management forms an important and integral part of our oral medicine specialty. Only oral physicians are well-trained to provide non-surgical treatment of these complex disorders. Today, the escalating costs of drugs and several adverse effects associated with modern medicines have led to the search of alternative systems all over the world. Hence, this study is an effort to assess the efficacy of holistic approaches (naturopathy and yoga) alone as well as in combination with pharmacological therapy in the treatment of chronic orofacial pain of non-odontogenic origin. Materials and Methods: The present study was conducted on 60 patients who were randomized into three groups A, B and C, each group consisting of 20 patients (10 of myofascial pain and 10 of trigeminal neuralgia). In group A it was prescribed conventional medicines for their respective treatment. Holistic approaches (naturopathy and yoga) were added with conventional pharmacological therapy in group B and only holistic approaches were performed in group C. The duration of treatment was of 3 months a and the patients were analysed using pain scale, quality of life scale (QOL) and stress scale after every ten days follow-up. Results: The patients of trigeminal neuralgia showed best result when treated with pharmacological treatment. The holistic approaches showed significant results only when combined with pharmacological therapy for the treatment of trigeminal neuralgia. On the other hand, holistic approaches works best in myofascial pain both alone and in combination with pharmacological therapy. Acupuncture and facial massage along with yoga have a great impact on quality of life by reducing stress and anxiety of the patient. Conclusion: Holistic approaches are useful means in treating patients with chronic orofacial pain as it eliminates the risk of adverse effects associated with long term use of muscle relaxants and anti-convulsants.

Keywords: Acupuncture and yoga, naturopathy, orofacial pain, pharmacological treatment


How to cite this article:
Bhalla K, Kamarthi N, Malik SS, Goel S, Gupta S. Comparison of conventional pharmacological therapy and holistic approaches (Naturopathy and Yoga) in the management of chronic orofacial pain: A randomized controlled study. J Indian Acad Oral Med Radiol 2019;31:29-35

How to cite this URL:
Bhalla K, Kamarthi N, Malik SS, Goel S, Gupta S. Comparison of conventional pharmacological therapy and holistic approaches (Naturopathy and Yoga) in the management of chronic orofacial pain: A randomized controlled study. J Indian Acad Oral Med Radiol [serial online] 2019 [cited 2019 Jun 17];31:29-35. Available from: http://www.jiaomr.in/text.asp?2019/31/1/29/256903




   Introduction Top


Chronic orofacial pain disorders (COFP) are highly prevalent and stressful conditions involving head, face, and neck. It is an umbrella term devoted to the diagnosis and management of chronic, complex, facial pain, and oromotor disorders. The oral physician needs to have a detailed knowledge of different non odontogenic pain conditions for proper diagnosis and a multidisciplinary approach of management. Therefore, here comes the need of well-equipped orofacial pain clinic where all these conditions can be treated under one roof.[1],[2]

The treatment provided in most of the cases is a supportive one, not a definitive one. That is, we just try to alleviate the patients pain by medications or so, rather than focusing on the cause of pain. Inappropriate treatment leads to no improvement in patient's condition and hence worsens the scenario.[3] Today, the escalating costs of drugs and several adverse effects associated with modern medicines have led to the search and revival of alternative, indigenous systems of medicines all over the world. This movement towards other systems is patient led. People everywhere are turning increasingly towards a natural, healthy life style. Judging by the immense popularity of medical systems such as Ayurveda, Naturopathy and Yoga over the past two or three decades, it is obvious that these systems offer the promise of cure.[4]

Understanding the pain neurobiology, and musculoskeletal structure it is the key to the development of better and safer therapeutics. It is necessary to stress the need for more randomized controlled clinical trials. New and exciting discoveries will hopefully put an end to the burden of chronic orofacial pain conditions in the near future.

To the best of our knowledge, till date there are no studies existing in literature which have compared and used a combined pharmacological and holistic approach in the treatment of orofacial pain disorders. Hence, this research is the first ever study and effort to assess the efficacy of holistic approaches (Naturopathy and Yoga) alone as well as in combination with pharmacological therapy in the treatment of chronic orofacial pain of non odontogenic origin.


   Materials and Methods Top


The present study was conducted in the Department of Oral Medicine and Radiology, Subharti Dental College and Hospital and Maharishi Aurobindo Subharti Institute of Naturopathy and Yogic Sciences, Meerut on 60 patients diagnosed with chronic Orofacial pain. Ethical clearance was obtained from institutional ethical committee to conduct study.

The subjects were randomized in three groups A, B and C. Each group consisted of 20 patients (10 diagnosed with myofascial pain and 10 diagnosed with trigeminal neuralgia).

Group A, patients were prescribed conventional medicines for their respective treatment. The myofascial pain patients were advised ibuprofen (400 mg) with chlorzoxazone (250 mg) in combination, twice daily for two weeks along with topical application of volini gel on the affected side 4-5 times a day. The patients who suffered from trigeminal neuralgia were advised carbamazepine 100-200 mg three times a day (depending upon pain intensity), and were followed up after every 10 days.

Group B patients were prescribed the same conventional medicines and then they were given holistic treatment which included acupuncture, facial massage therapy, hot and cold therapy, facial exercises, yoga and meditation. The first step in the treatment included 30-45 minutes acupuncture treatment in which patient were made to lie down in a supine position. Local skin disinfection with iodophor was conducted. The acupuncture needles (0.35 mm *65 mm) were slowly punctured at the indicated acupoints, forming a 45-degree angle with the skin. When patients had a feeling of soreness after the needle was punctured into 45-60 mm, rotating, lifting and thrusting in a moderate strength by acupuncture reduction method of filiform needles were conducted. The needles were retained for 30-45 minutes, during which the needle was punctured into the acupoint once. The acupuncture was conducted once daily for ten days. This was followed by 15 minutes facial massage therapy, and hot and cold therapy. The cold fomentation was not given in trigeminal neuralgia patients as it is contraindicated. In trigeminal neuralgia facial massage was done with warm sesame oil alone. On the other hand, Epsom salt was added to warm sesame oil while giving facial massage to patients suffering from myofascial pain. Here the Epsom salt worked as a muscle relaxant. Patients were also made to do certain facial exercises (20 reps each). These included chin in and out (flexion and extension), mouth open and closed, chin retraction, shoulder shrugging, and jaw movements right and left, and blowing of cheeks.

Apart from the above treatment modalities, patients were asked to perform meditation and various asanas and pranayama of yoga for stress reduction. Theses asanas and pranayama were “Surya Anulom Vilom, Surya Bhedna, Nadishodhna, Bhastrika, Shavasan, Vajrasan, Vakrasan, Balssan and Tadasan.” For home remedies, apart from hot and cold fomentation in myofascial pain and hot fomentation in trigeminal neuralgia, patients were asked to practise facial exercises as well as yoga and meditation.

In group C patients, only holistic approaches were performed in the same way as given in group B.

The duration of treatment was of 3 months and all the patients were analysed using pain scales, stress scale and quality of life scale before treatment and after every 10 days follow-up. Pain diary was provided to all patients for home follow-up. All the results obtained were statistically analysed using Statistical package for Social Sciences (ver. 17.0; SPSS, Inc Chicago, IL, USA). The statistical tests employed were Kruskal-Wallis test, Mann-Whitney test and Wilcoxon Signed Rank test. A probability (P) value of < 0.05 was considered to be significant and P < 0.001 was considered to be highly significant.


   Results Top


Our results showed that holistic approaches (naturopathy and yoga) when given individually to patients suffering from trigeminal neuralgia does not prove beneficial. However, improvement in the quality of life was noticed when holistic approaches were used (PVAS= 0.180, PQOL= 0.180, PSTRESS= 0.180). On the contrary, when holistic approaches was combined with drug therapy the results achieved were better (PVAS= 0.007, PQOL= 0.013, PSTRESS= 0.017) [Table 1], [Table 2], [Table 3] and [Figure 1], [Figure 2], [Figure 3].
Table 1: Intra group change in Intensity (VAS) in Trigeminal Neuralgia cases

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Table 2: Intra group change in QOL in Trigeminal Neuralgia cases

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Table 3: Intra group change in Stress Scale in Trigeminal Neuralgia cases

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Figure 1: Bar graph showing Pain intensity (VAS) in trigeminal neuralgia cases

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Figure 2: Bar graph showing QOL in trigeminal neuralgia cases

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Figure 3: Bar graph showing Stress scale in trigeminal neuralgia cases

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The pharmacological treatment (carbamazepine) showed best results in patients with trigeminal neuralgia (PVAS= 0.005, PQOL= 0.008, PSTRESS= 0.005).

On the other hand, equivalent reduction was seen in intensity of pain in myofascial pain patients when treated with combined therapy (pharmacological and holistic approaches) (PVAS= 0.005) and holistic therapy alone (P = 0.005) as compared to pharmacological treatment alone (P = 0.007) [Table 4] and [Figure 4]. However, marked improvement was seen in the quality of life and stress levels of the patient (PQOL= 0.005, PSTRESS= 0.005) when treated with combined therapy (pharmacological treatment and holistic treatment) followed by holistic approaches alone (PQOL= 0.011, PSTRESS= 0.011). No significant improvement seen in quality of life of the patients when treated with pharmacological treatment (P = 0.121) though significant improvement was appreciated in stress level of these patients (P = 0.024) [Table 5], [Table 6] and [Figure 5], [Figure 6].
Table 4: Intra group change in Intensity (VAS) in Myofascial Pain cases

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Figure 4: Bar graph showing Pain intensity (VAS) in myofascial pain cases

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Table 5: Intra group change in QOL in Myofascial Pain cases

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Table 6: Intra group change in Stress Scale in Myofascial Pain cases

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Figure 5: Bar graph showing QOL in myofascial pain cases

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Figure 6: Bar graph showing Stress scale in myofascial pain cases

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   Discussion Top


The present study evaluated the efficacy of holistic approaches (naturopathy and yoga), and pharmacological therapy in the treatment of chronic orofacial pain (Myofascial pain and trigeminal neuralgia). The present study provided a vision that pharmacology along with holistic approach can go hand in hand rebuilding the era of modern therapeutics. The main aim of this study was to undertake all the parameters into consideration while treating orofacial pain disorder patients whether it is the intensity of pain, the stress and their quality of life, etc., so that we can provide promising results to our patients by improving all the above factors simultaneously.

Entities such as pain, stress and quality of life in a person are difficult to analyze. Various studies have used different methods to quantify pain like VAS scale,[4] Computer face scale,[5] Mc. Gill pain questionnaire,[6] Face rating scale.[7] Stress has been assessed by various authors using different stress scale like Perceived stress scale,[8] DASS questionnaire.[9] Similarly, quality of life has also been analyzed by various authors using standardized scales like SF-36 Health Survey,[10] Korean version of the Beck Anxiety inventory and Quality of Life.[11]

This study uses standardized scales- VAS for pain, quality of life scale (adopted by American Chronic Pain Association), and stress scale adopted by American Heart Association for analysis purpose. In this study, our analysis is purely quantitative utilizing Kruskal-Wallis test, Mann-Whitney test and Wilcoxon Signed Rank test. We have used most simplified but standardized scales to quantify pain, quality of life and stress so that statistical analysis was simplified and comparison between treatment methods could be done easily.

The mainstay of treatment in trigeminal neuralgia remains use of carbamazepine however, long term use of carbamazepine is associated with bone marrow depression. Thus, we chose this disease as a part of our study to see if holistic approaches serve as an option to its treatment. In the present study in group A, 10 patients who were treated with pharmacological treatment (carbamazepine) showed drastic improvement in the intensity of pain, quality of life and stress level, as measured on their respective scales. No remarkable medicinal adverse effects were reported in our patients during the course of the treatment except giddiness (in few patients) during initial week of intake of prescribed doses. Thus, in our study, pharmacological treatment proved efficient in treating trigeminal neuralgia. This was consistent with the studies done by Taylor JC, Brauer S, et al. (1981);[12] Sindrup, Soren H, et al. (2002);[13] Grunseth G, Cruccu G, et al. (2008)[14] and Liu H, Li H, et al. (2010)[15] which have proved carbamazepine to be an effective drug in the treatment of trigeminal neuralgia.

In our study, in group B patients, where holistic approaches (naturopathy and yoga) were combined with pharmacological therapy, all the patients showed better improvement in the pain condition. Noticeable improvement was also appreciated in the quality of life and stress levels in these patients during the course of the treatment. Undoubtedly even surgical methods exist for the treatment of trigeminal neuralgia but sometimes we came across certain group of patients who are not willing for the surgical procedures due to the fear or sometimes due to its cost. Therefore, in such patients pharmacological therapy along with holistic treatment (acupuncture, meditation, yoga, etc.) can be fruitful as it not only provide pain relief but also reduces their anxiety and improves quality of life. Thus, our study shows that combined naturopathy and pharmacology is also an effective approach in improving quality of life of patients suffering from trigeminal neuralgia.

In the present study, in group C patients with trigeminal neuralgia, out of 10 only 2 patients treated with holistic therapy responded to the treatment and got minimal relief. Thus, our study failed to show any significant improvement in patients of trigeminal neuralgia who were treated with holistic treatment alone. This may be due to the high pain intensity levels the patients were not comfortable enough to go through the acupuncture and massage process. Another possible reason is their disturbed life due to pain and added anxiety and fear which prevented them to visit regularly for naturopathic treatment. This is contrary to the study done by Liu S (2018)[16] who observed the clinical efficacy of acupuncture therapy in 150 patients diagnosed with primary trigeminal neuralgia. Their results showed that the intensity of pain in the acupuncture group were lower than those in the drug group (Both P < 0.001). The total effective rate in the acupuncture group was also notably superior to those in the drug group (85.33% v/s 62.67%, P = 0.002). Even Liu Z, Fang G (2004)[17] in their study proved that acupuncture may turn the pathological state into a normal physiological state and brings a quicker recovery for patients with facial spasm, trigeminal neuralgia etc.

Apart from trigeminal neuralgia, most patients who came to our Out patient department (OPD) were of Myofascial pain. In the present study, the patients who suffered from myofascial pain were also divided into three groups (A, B and C) respectively. Group A consisted of 10 patients who were prescribed pharmacological treatment alone and the result revealed improvement in the pain intensity of patients. The episode of pain reduced to minimal during 3rd and 4th follow-up. No episode of pain was reported during the last two follow ups after discontinuing the medications. The stress levels of patients were also decreased. Beebe, Frank A, et al. (2005)[18] presented a clinical and pharmacologic review of skeletal muscle relaxants for musculoskeletal conditions. The authors came across only a limited number of high-quality, randomized, controlled trials (RCTs) which provide evidence of the effectiveness of Nonsteroidal anti- inflammatory drugs (NSAIDs) or Skeletal muscle relaxants (SMRs) in the treatment of acute, uncomplicated Musculoskeletal disorders (MSDs). According to them the combination of an SMR and an NSAID or COX-2 inhibitor or the combination of SMR and tramadol/acetaminophen is superior to single agents alone. However, it is not favourable to use long term drug therapy as it is associated with adverse effects.

In group B, 10 patients with myofascial pain when treated with pharmacological treatment along with holistic therapy showed a significant improvement in the VAS score during the early course of the treatment which continued till the end of the treatment. Along with this patients have also showed marked improvement in their stress levels and quality of life, as measured on their respective scales. The treatment has inculcated positivity in them by changing their perspective towards the disease, problems and how to face them which was remarkable. Thus, the present study shows that naturopathy when combined with yoga and pharmacology can be effective treatment modality for the treatment of myofascial pain.

In the present study, group Cpatients with myofascial painwho were advised holistic treatment (naturopathy and yoga) alone also showed significant improvement in the VAS score. Some patients responded to the treatment at early stage while other responded to the treatment at later stages. Along with the VAS score, significant improvement was also noticed in the stress levels and quality of life as measured on their respective scales. No side effect of the treatment was reported. Thus, our study shows that holistic therapy is also an effective treatment modality and therefore can be used alternative to pharmacological treatment for the treatment of myofascial pain thus saves the patient from unnecessary side effect resulting from medicines. Similar study was done by Shen YF, Younger J, et al. (2010)[19] but it only evaluated the effectiveness of acupuncture in patients diagnosed with chronic myofascial pain of the jaw muscles. Results revealed significant reduction in jaw pain of the patients (P = 0.04), jaw/face tightness (P = 0.04), and a significant increase in the pain.

Chronic pain is multi-dimensional. At the physical level, itself, beyond the nociceptive pathway, there is hyper arousal state of the components of the nervous system, which negatively influences tension component of the muscles, patterns of breathing, energy levels and mind set, all of which exacerbate the distress and affects the quality of life of the individual and family. It is said when the individual has a positive mind-state healing happens more quickly, whereas if the mind state is negative, healing may be prolonged. Therefore, an ancient old tradition, Yoga is now regarded in the western world as a holistic approach to health and is classified by the National Institute of Health as a form of complementary and alternative medicine. In our study, yoga along with meditation helped in improved quality of life in both patients with trigeminal neuralgia and myofascial pain. Various Asanas and Pranayama were taught to the patients and were made to do at least thrice a day for approximately 45 minutes. Patients were so relieved and satisfied after seeing the favourable results that they have started practicing yoga in daily routine. It really changed their perspective towards pain, anxiety, stress which in turn improved the quality of life. Thus, we can say that quality of life increases if one practices yoga and meditation.

This was consistent with all the previous studies done by Kabatt J, lipworth L, et al. (1985);[20] Vallath N (2010),[21] and Woodyard C (2011)[22] which have proved that yogic practices enhances muscular strength, reduces stress, anxiety, depression and chronic pain and enhance overall well-being and quality of life.

The major strength of our study is that we did a proper follow-up after every ten days. This helped us to minutely observe the changes occurring in all the three groups from initiation of the treatment and after even three months of follow-up. The other important aspect of our study was that we were not confined to only one aspect of chronic orofacial pain. We evaluated both myofascial pain as well as neuralgic pain. Also, we made sure to evaluate stress and quality of life of the patients and not only focus just on pain. Another useful aspect of the present study was that as oral medicine specialist we were able to understand details of acupuncture and advanced facial massage. The practice of yoga significantly impact quality of life and helps patients forget their pain, anxiety and stress. Our study focus on positivity, the more positive we will be, more we will be relieved of our sufferings. Lastly, our study shows that holistic approaches are useful means of treating patients with chronic orofacial pain, thus eliminating the risk of adverse effects associated with long term use of muscle relaxants and anticonvulsants.

The limitation of present study was the lack of patient's knowledge and faith in new treatment modalities (naturopathy and yoga). No matter holistic therapy provides promising and permanent relief to the patient with no adverse effects but due to its slow mechanism of action immediate relief cannot be achieved in shorter duration of time as compared to pharmacological treatment. Though, we were able to counsel the patients but they still urged for pharmacological treatment and few of them even changed the oral physician as no drugs were advised to them.

Although, we were able to motivate our patients for regular and frequent follow-up as we had smaller sample size, but it still remains a major barrier in researches involving holistic approaches. This is because these approaches require frequent and regular follow-ups of patients to evaluate the improvements occurring after every cycle. Most of the patients fail to turn up for regular follow-ups as they either belong to working class (private employees, farmers, masons etc.) or they are housewives and villagers from remote areas.


   Conclusion Top


Thus, our study highlights the significance of holistic approaches in treatment of chronic orofacial pain. Holistic approaches are useful means of treating patients with chronic orofacial pain, as it eliminates the risk of adverse effects associated with long term use of muscle relaxants and anticonvulsants. Also, practicing of yoga along with meditation has a significant impact on quality of life and helps patients forget their pain, anxiety and stress. However, individual role of holistic approach in the treatment of trigeminal neuralgia need to be evaluated in further studies using large sample size. To the best of our knowledge this is the first study done which has assessed the efficacy of holistic approaches (Naturopathy and Yoga) along with pharmacological therapy in the treatment of orofacial pain. In future, further studies with larger sample size should be conducted taking into consideration multi-disciplinary approach for the management of chronic orofacial pain patients, in order to improve treatment outcomes and avert more serious consequences.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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[PUBMED]  [Full text]  


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