Research Protocol
 

By Dr. Natarajan Shanmugasundaram , Dr. P Sathiyarajeswaran , Dr. M Kannan
Corresponding Author Dr. Natarajan Shanmugasundaram
Siddha Central Research Institute, Chennai, Tamilnadu, - India 600106
Submitting Author Dr. Natarajan Shanmugasundaram
Other Authors Dr. P Sathiyarajeswaran
Siddha Central Research Institute, Chennai, Tamilnadu, - India

Dr. M Kannan
Siddha Central Research Institute, Chennai, Tamilnadu, - India

INDIAN MEDICINE

Siddha Medicine, Ceganavatham, Cervical Spondylosis, Varmam

Shanmugasundaram N, Sathiyarajeswaran P, Kannan M. An Open Clinical Trial for Cegana Vatham using Varmam Procedure. WebmedCentral INDIAN MEDICINE 2012;3(2):WMC002968
doi: 10.9754/journal.wmc.2012.002968

This is an open-access article distributed under the terms of the Creative Commons Attribution License(CC-BY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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Submitted on: 03 Feb 2012 07:16:38 AM GMT
Published on: 03 Feb 2012 03:57:12 PM GMT

Introduction


Most patients who present with neck pain have “non-specific (simple) neck pain,” where symptoms have a postural or mechanical basis. Aetiological factors are poorly understood [1] and are usually multifactorial, including poor posture, anxiety, depression, neck strain, and sporting or occupational activities.[2] Neck pain after whiplash injury also fits into this category, provided no bony injury or neurological deficit is present.[3] When mechanical factors are prominent, the condition is often referred to as “cervical spondylosis,” although the term is often applied to all non-specific neck pain. Mechanical and degenerative factors are more likely to be present in chronic neck pain.
In cervical spondylosis, degenerative changes start in the intervertebral discs with osteophyte formation and involvement of adjacent soft tissue structures. Many people over 30 show similar abnormalities on plain radiographs of the cervical spine, however, so the boundary between normal ageing and disease is difficult to define.[4] Even severe degenerative changes are often asymptomatic, but can lead to neck pain, stiffness, or neurological complications.
About two thirds of the population have neck pain at some time in their lives, [5,6] and prevalence is highest in middle age. After back pain, neck pain is the most frequent musculoskeletal cause of consultation in primary care worldwide
Cervical spondylosis is usually diagnosed on clinical grounds alone Symptoms are Cervical pain aggravated by movement, Referred pain (occiput, between the shoulder blades, upper limbs), Retro-orbital or temporal pain (from C1 to C2), Cervical stiffness-reversible or irreversible, Vague numbness, tingling, or weakness in upper limbs, Dizziness or vertigo, Poor balance, rarely, syncope, triggers migraine, “pseudo-angina” [15]. The Signs are Poorly localised tenderness, Limited range of movement (forward flexion, backward extension, lateral flexion, and rotation to both sides), Minor neurological changes like inverted supinator jerks (unless complicated by myelopathy or radiculopathy) Although pain is predominantly in the cervical region, it can be referred to a wide area, and is characteristically exacerbated by neck movement. Neurological change should always be sought in the upper and lower limbs, but objective changes occur only when spondylosis is complicated by myelopathy or radiculopathy, or when unrelated causes like disc prolapse, thoracic outlet obstruction, brachial plexus disease, malignancy, or primary neurological disease are present.
Currently, a balanced view of the management of neck pain cannot be given by discussing evidence based treatments only. Stress management and postural advice on daily activities, work, and hobbies may be useful in some patients. Patients should be advised to use only one pillow at night. When pain is severe, analgesics and anti-inflammatory agents are widely used, despite the lack of evidence that they work. Low dose tricyclic antidepressants, like amitriptyline 10-30 mg per night, might be more effective. Yoga, pilates, and the Alexander technique all improve neck posture, but their value in treating neck pain is uncertain.
Acute neck pain not due to whiplash injury and found limited evidence of benefit for manipulation or mobilisation therapy.[3,4] No evidence exists for the efficacy of non-steroidal anti-inflammatory agents or analgesics. The evidence that muscle relaxants relieve pain more than placebo is weak, and the incidence of side effects like drowsiness is high. Studies of the early treatment of whiplash provide moderate evidence that early mobilisation physiotherapy[17-20] and advice to “act as usual”[21] are more effective than immobilisation and less active treatments in speeding up recovery and reducing chronic disability. Less evidence exists for the benefit of home exercise regimens,[22] pulsed electromagnetic field therapy,[23] and multimodal therapy.
Randomised controlled trials identified by systematic reviews[5-8] provide moderate evidence that various exercise regimens-using proprioceptive, strengthening, endurance, or coordination exercises-are more effective than usual care (analgesics, non-steroidal anti-inflammatory drugs, or muscle relaxants)[9,25] or stress management,[10,11] although not all studies have found exercise beneficial.[12] One randomised controlled trial found exercise plus infrared heat no more effective than transcutaneous electrical nerve stimulation plus heat at relieving pain at six weeks and six months, although both were better than heat alone.[26]
Randomised controlled trials included in systematic reviews of manual treatments (mobilisation physiotherapy or manipulation)[1, 4, 5 ,13-16] provide limited evidence that mobilisation physiotherapy[17 18] and manipulation[17] are more effective for chronic neck pain than less active treatments (drug treatment, education, counseling). However, manipulation has occasionally been associated with serious neurological complications (around 5-10 per 10 million manipulations).[27]
Mobilisation, manipulation, and exercise seem to be equally effective.[19,20,28] A study comparing combined exercise and manipulation with either modality alone found the combination to be more effective at three months,[21] but no difference was seen compared with exercise alone at one and two years.[22] However, another pragmatic study found no advantage at six weeks or six months of adding manual therapy (63% of patients had mobilisation physiotherapy) or heat (shortwave diathermy) to exercise and advice.[23]
Systematic reviews of weak randomised controlled trials provided no conclusive evidence about the effectiveness of acupuncture[24] or traction[25] compared with a range of other treatments in patients with chronic neck pain. The addition of psychotherapy techniques like cognitive behavioural therapy also added little to physical or mechanical treatment alone.[26].
Cegana vatham is equated with Cervical Spondylosis in Siddha. The signs and symptoms of "CeganaVatham" is described in the texts of "Yugi vaidhya sindhamani" and "Pararaja sekaram". In "Yugi vaidhya sindhamani" the disease is described with the following symptoms Pain below neck to lowback, Pain both upper limbs, Weight feeling over the body, Depression and giddiness, Burning in the both eyes, Constipation and Pain felt like scorpion bite over body. In "Para raja sekaram" the disease is described with the following symptoms Pain below neck to lowback, Severe pain felt in both arms and Numbness with tingling in the upper limbs
Siddha system of medicine emphazise different modalities of treatments among them drugless therapy is considered to be supreme. Varmam therapy is a non invasive procedure especially treating musculo skeletal disorders and neurological disorders.
Varma therapy refers to the treatment of injured energy centres of the body which could be located in muscles, bones, nerves, joints or veins. It belongs to varmakkalai which consists in two arts (kalai) opposed by essence: medical art (varmam) for curing injuries, and martial art. The treatment consists in locating injured point(s), pressing and massaging it (them) with an intensity which depends on injury and energy centres.
The failure of standard treatment for the cervical spondylosis in turns search for a good treatment modalities in traditional system of medicine. It is need of the hour to establish the non invasive Varmam prodcedure for the treatment of cervical spondylosis

Trial Design


An Open controlled clinical study.

Sample size


30 cases with Varmam application alone.

Treatment


Stimulation of following Varmam Points
In the neck (Kannan Rajaram, 2007)
1. Vilangu Varmam
2. Kakkatai varmam
3. Aga, Pura Tharai varmam
4. Kilimuga Varmam
In the hand (Kannan Rajaram, 2007)
1. Kochu varmam
2. Pura Tharai varmam
3. Gurunadi varmam
4. Thutikkai varmam
5. Vellai varmam
6. Peruviral kavuli varmam
Duration of treatment: 7 days.

Criteria for inclusion


Corresponding to diagnostic standards of cervical spondylosis:
* Patients with chief complaint of neck pain;
* One or more neck pain, neck stiffness attack on average per month for at least 3 months;
* VAS scores more than 3 points at entry;
* The result of antero-posterior and lateral radiogragh corresponds to x-ray diagnostic standards of cervical spondylosis, or MR/CT scan shows the degeneration of cervical spine or cervical disc heniation.
* Age between 18- 60 years.

Criteria for exclusion


Corresponding to the diagnostic standards of cervical spondylosis myelopathy:
* Suffering from severe systemic diseases such as diabetes mellitus, cardio-cerebrovascular disease, tumors and diseases that researchers consider unsuitable for research.
* Having neck trauma/fracture/surgery history, neurologic impairment (such as myasthenia or abnormal spinal nerve reflex).
* Congenital spinal abnormality, systemic diseases of bones or joints.
* Pregnant or lactation period women.
* Receiving current treatments for cervical spondylosis (medicine or non-medicine).

Criteria for withdrawal


During the course of the trial there may be certain potential adverse threats and If any other side effects and other symptoms are observed then the trial drugs will be withdrawn and will be treated symptomatically.

Methods of assessment


Clinical assessment will be done (O) and every day till the completion of treatment. The Lab investigations (Biochemical markers) will be recorded before treatment. The X-ray will be done before and after the completion of the treatment.

Success of treatment


30% or more in mobilization without pain will be considered as significant improvement.

References


1. Binder AI. Neck pain syndromes. Clinical Evidence. Search date December 2006.
www.clinicalevidence.com/ceweb/conditions/msd/1103/1103_updates.jsp.
2. Binder AI. Cervical pain syndromes. In: Isenberg DA, Maddison PJ, Woo P, Glass DN, Breedveld FC, eds. Oxford textbook of rheumatology. 3rd ed. Oxford: Oxford Medical Publications, 2004:1185-95.
3. Vernon HT, Humphreys BK, Hagino CA. A systematic review of conservative treatments for acute neck pain not due to whiplash. J Manipulative Physiol Ther 2005;28:443-8.
4. Canadian Chiropractic Association, Canadian Federation of Chiropractic      Regulatory Boards, Clinical Practice Guidelines Development Initiative,Guidelines      Development Committee (GDC). Chiropractic clinical practice guideline:      evidence-based treatment of adult neck pain not due to whiplash. J Can Chiropr Assoc 2005;49:158-209.
5. Aker PD, Gross AR, Goldsmith CH, Peloso P. Conservative management of mechanical neck pain: systematic overview and meta-analysis. BMJ 1996;313:1291-6.
6. Philadelphia Panel. Evidence-based clinical practice guidelines on selected rehabilitation interventions for neck pain. Phys Ther 2001;81:1701-17.
7. Sarig-Bahat H. Evidence for exercise therapy in mechanical neck      disorders. Man Ther 2003;8:10-20.
8. Kay TM, Gross A, Goldsmith C, Santaguida PL, Hoving J, Brontfort G, et al, Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev 2005;(3):CD004250.
9. Ylinen J, Takala E, Nykanen M, Hakknen A, Malkia E, Pohjolainen T, et al. Active neck muscle training in the treatment of chronic neck pain in women: a randomized controlled trial. JAMA 2003;289:2509-16.
10. Waling K, Sundelin G, Ahlgren C, Jarvholm B. Perceived pain before and after three exercise programs—a controlled clinical trial of women with work-related trapezius myalgia. Pain 2000;85:201-7.
11. Waling K, Jaörvholm B, Sundelin G. Effects of training on female trapezius myalgia: an intervention study with a 3-year follow-up period. Spine 2002;27:789-96.
12. Viljanen M, Malmivaara A, Uitti J, Tinne M, Palmroos P, Laippala P.      Effectiveness of dynamic muscle training, relaxation training, or ordinary activity for chronic neck pain: randomised controlled trial. BMJ 2003;327:475-7.
13. Hurwitz EL, Aker PD, Adams AH, Meeker WC, Shekelle PG. Manipulation and mobilization of the cervical spine: a systematic review of the literature. Spine 1996;21:1746-60.
14. Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J 2004;4:335-56.
15. Gross AK, Hoving JL, Haines TA, Goldsmith CH, Kay T, Aker P, et al, Cervical Overview Group. Manipulation and mobilisation for mechanical neck disorders. Cochrane Database Syst Rev 2004;(1):CD004249.
16. Oduneye F. Spinal manipulation for chronic neck pain. In: Bazian Ltd, ed. STEER: Succinct and Timely Evaluated Reviews 2004;4(4). Bazian Ltd and Wessex Institute for Health Research and Development, University of Southampton.
17. Koes BW, Bouter LM, van Mameren H, Essers AH, Vestegen GM, Hofhuizen DM, et al. Randomised clinical trial of manipulative therapy and physiotherapy for persistent back and neck complaints: results of one year follow up. BMJ 1992;304:601-5.
18. Hoving J, Koes B, de Vet H, van der Wildt DA, Assendelft WJ, van Mameren H, et al. Manual therapy, physical therapy, or continued care by a general practitioner for patients with neck pain. A randomized, controlled trial. Ann Intern Med 2002;136:713-22.
19. Jordan A, Bendix T, Nielsen H, Hansen ER, Host D, Winkel A. Intensive training, physiotherapy, or manipulation for patients with chronic neck pain. A prospective, single-blinded, randomized clinical trial. Spine 1998;23:311-9.
20. Hurwitz EL, Morgenstern H, Harber P, Kominski GF, Yu F, Adams AH. A randomized trial of chiropractic manipulation and mobilization for patients with neck pain: clinical outcomes from the UCLA neck-pain study. Am J Public Health 2002;92:1634-41.
21. Bronfort G, Evans R, Nelson B, Aker PD, Goldsmith CH, Vernon H. A randomized clinical trial of exercise and spinal manipulation for patients with chronic neck pain. Spine 2001;26:788-97.
22. Evans R, Bronfort G, Nelson B, Goldsmith CH. Two-year follow-up of a randomized clinical trial of spinal manipulation and two types of exercise for patients with chronic neck pain. Spine 2002;27:2383-9.
23. Dziedzic K, Hill J, Lewis M, Sim J, Daniels J, Hay EM. Effectiveness of manual therapy or pulsed shortwave diathermy in addition to advice and      exercise for neck disorders: a pragmatic randomized controlled trial in physical therapy clinics. Arthritis Care Res 2005;53:214-22.
24. White AR, Ernst E. A systematic review of randomized controlled trials of acupuncture for neck pain. Rheumatology 1999;38:143-7.
25. Van der Heijden GJ, Beurskens AJ, Koes BW, Assendelft WJ, de Vet HC, Bouter LM. The efficacy of traction for back and neck pain: a systematic, blinded review of randomized clinical trial methods. Phys Ther 1995;75:93-104.
26. Karjalainen K, Malmivaara A, Van Tulder M, Roine R, Jauhianen M, Hurri H, et al. Multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain among working age adults. Cochrane Database Syst Rev 2002;(3):CD002194.
27. Boswell MV, Hansen HC, Trescot AM, Hirsch JA. Epidural steroids in the      management of chronic spinal pain and radiculopathy. Pain Physician 2003;6:319-34.
28. Fouyas IP, Statham PF, Sandercock PA. Cochrane review on the role of surgery in cervical spondylotic radiculomyelopathy. Spine 2002;27:736-47.
29. Persson LC, Carlsson CA, Carlsson JY. Long-lasting cervical radicular pain managed with surgery, physiotherapy, or a cervical collar: a prospective randomised study. Spine 1997;22:751-8.
30. Kannan Rajaram. (2007). Varma pullikainl iruppitam. kanyakumari: A.T.S.V.S.

Source(s) of Funding


none

Competing Interests


none

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