跳至主要内容
临床试验/CTRI/2024/05/067528
CTRI/2024/05/067528尚未招募3 期

A comparative clinical trial on agnikarma, autologous whole blood injection and local infiltration of steroid in tennis elbow

National Institute of Ayurveda,Amer road,Jaipur,Rajasthan1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年5月27日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Changes in the PRTEE (Patient Rated Tennis Elbow Evaluation) Scale.

研究概览

简要总结

Tennis elbow also known as lateral epicondylitis of the humerus, is a common ailment that causes pain and tendernesson pressure over a very localized spot on the lateral side of the elbow joint, immediately below the epicondyle.It causes restricted movements of the forearm due to strain of the common extensor tendon from the lateral epicondyle of the Humerus**.**Every year, 1-3% of adults mainly those aged from 35 to 55 years, with an equal gender distribution, are thought to develop tennis elbow, which is more likely in the dominant arm.It is typically regarded as an overuse injury involving repeated wrist extension against resistance, although it can occur from a series of minor pronation and supination strains.As the term Tennis Elbow suggests, up to 50% all tennis players experience this symptom due to various reasons. It is also seen in labourers who use heavy tools or are engaged in repetitive gripping or lifting tasks.The tennis Elbow is also known by other names like Tendonosis, Lateral Epicondylitis and Angiofibroblastic Hyperplasia. An area of degenerative alteration or non-specific inflammation at the site of origin of extensor tendons appears to be the underlying pathophysiology of Tennis Elbow. When the forearm is semi-pronated, the muscles are tensed, if rapid activity was performed, a sudden flexion of the wrist pulls the forearm’s extensor muscle at its epicondylar attachments, which results in damage and cause Lateral epicondylitis.Amongst the extensor tendons taking origin in the region of the lateral epicondyle, the extensor carpi radialis brevis has often been implicated as the key structure in Tennis Elbow. Its unusual anatomy exposes it to shearing forces in almost all movements of the arm.

In Ayurveda literature, the diseases of ligaments and tendons were mentioned in SnayugataVikara.  Snayugatavata means vitiated Vata Dosha causes various diseases taking Snayu as Adhisthana. Acharya Sushruta has explained various modalities to manage Snayu, Sandhi Vikara and it includes Snehana, Upanaha, Agnikarma and Bandhana.

Current epidemiological status and morbidity associated with tennis elbow necessitates its safe, effective and economic management.There is a need to explore the most effective management modality among the various interventions used to manage it in Ayurveda and contemporary system of medicine

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient of age 25-60 year of either gender Patients presenting with the clinical features of Tennis Elbow Positive Cozen’s test Positive Mill’s maneuver test Positive Maudsley’s test Ability to respond the questionnaire independently.

排除标准

  • Patients having open surgical procedure of Tennis Elbow Recent fracture of Radial head, traumatic or post traumatic pain, head injury, spine injury Patient having introsseosus nerve syndrome, radial tunnel syndrome Patient having anatomical defect and congenital structural defect of elbow joint Patients having joint disorders (viz.
  • RA, OA, Gout).
  • Patient having systemic ailments like anaemia, uncontrolled diabetes mellitus, uncontrolled hypertension and features of peripheral neuropathy etc.
  • Patients on long term steroids for any disease.
  • Insane, mentally instable, unconscious or semiconscious patients.
  • Patients who required specific treatment for some surgical disease.
  • Patients with history of ongoing malignancy, chemotherapy or Radiotherapy.
  • Presence of any local infection, sinuses or skin disease on the proposed site of intervention.
  • with peripheral vascular disease or peripheral neuropathy.
  • Post Polio Paralysis or Cerebral Palsy on the affected limb Contraindications of Agnikarma in group A (Su.Su.12/14).

结局指标

主要结局

Changes in the PRTEE (Patient Rated Tennis Elbow Evaluation) Scale.

时间窗: 12 Months

Changes in VAS score.

时间窗: 12 Months

Improvement in the signs and symptoms of Tennis Elbow.

时间窗: 12 Months

次要结局

  • Improvement in the quality of life of the patients(18 Months)

研究者

发起方
National Institute of Ayurveda,Amer road,Jaipur,Rajasthan
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Poonam Garg

National Institute of Ayurveda ,Amer road,Jaipur,Rajasthan

研究点 (1)

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