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临床试验/CTRI/2025/09/094929
CTRI/2025/09/094929尚未招募不适用

Efficacy of Dry Cupping Therapy in Avabahuka: A Randomised Control Trial

Dr. Gaurav Prakash Londhe1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
1.Change in SPADI

研究概览

简要总结

Shoulder joint is the most mobile joint of human body with wide range of movements facilitating day to day work ranging from simple jobs like wearing clothes to complex ones like lifting objects. Imagine cessation of movement of our shoulder joint, attributed further by pain and stiffness. Routine life will be partially handicapped in this scenario. The clinical vignette described above goes by the name of Frozen Shoulder or Adhesive Capsulitis. It is most commonly associated with patients with Diabetes Mellitus. The prevalence of frozen shoulder is estimated to be 2 to 5 percent of the general population. Such patients have a lifetime risk of 10-20 percent of developing frozen shoulder.  Alternatively Supraspinatus Tendinitis also brings similar picture in front of us.Treatment of the above disease in early stage is with analgesics, intraextra capsular corticosteroid injections, which are hepatotoxic, nephrotoxic; produce gastric irritation. It also requires regular ‘pendulum’ exercises of the arm to prevent the capsule from over tightening. So, the patient has to go to physiotherapist for regular follow ups, which is too costly and time consuming. Acharya Sushruta has mentioned the symptom complex analogous to frozen shoulder/supraspinatus tendinitis in Avabahuka.  He opines the use of Raktamokshana in the management of Avabahuka. Raktamokshana has been described as “Ardha Chikitisa” by Acharya Sushruta. It provides quick relief in conditions of shoola (pain) and Shoth (Inflammation). There are various techniques of performing Raktamokshana out of which the technique of choice for the management of Avabahuka is Cupping Therapy. Shringa Therapy can be considered analogous to cupping therapy since vacuum created by suction to draw out blood is mainstay of the modus operandi of both the techniques. This is similar to Wet Cupping therapy. Similarly, Dry cupping can also be performed on the grounds that the ecchymosis thus created by negative pressure can be compared to Raktamokshana. Cupping Therapy has now 4 4 become a mainstay of Sports medicine and being utilized by even top Athletes like Michael Phelps. Chronic conditions like Avabahuka usually do not respond positively to standard protocol of management. Physiotherapy requires additional resources viz. time, money and patience. Raktamokshana is unchartered territory in the arena of Avabahuka management which require to be tapped in and researched upon to give low cost, safe and time bound remedy to its hold on our society. Study plan: Two groups, interventional involves dry cupping and control involves wet cupping therapy. 45 patients sample size per group. Follow up on day 15 and day 30. objective criteria involves range of motion and VAS.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patients diagnosed as Avabahuka.
  • (Rotator Cuff tendinopathy and Adhesive capsulitis).
  • Patients of any sex.
  • Patients of age group 20-60 years.
  • Patients irrespective of caste, religion, economical status.

排除标准

  • 1.Patient suffering from major trauma having dislocation or fracture at shoulder region.
  • 2.Patient suffering from any major systemic disorders excluding well controlled Diabetes Mellitus-type 2 (BSL-PP less than 200 mg per dl)
  • Those patients who need other emergency interventions like surgery and other means are excluded.
  • HIV, HBsAg positive patients are also excluded.
  • Patient suffering from Haematological disorders like thrombocytopenia, Von Willebrand’s disease, thalassemia etc.
  • Patient suffering from severe Anaemia (Hb less than 8 gm percent).

结局指标

主要结局

1.Change in SPADI

时间窗: 1. Baseline (Day 0), Week 6 (end of treatment | plus or minus 3 days). | 2.Baseline, Week 2, Week 4, Week 6, Week | 12. | 3.Baseline, Week 2, Week 4, Week 6, Week | 12 | chronologically.

(Shoulder Pain and Disability Index) total

时间窗: 1. Baseline (Day 0), Week 6 (end of treatment | plus or minus 3 days). | 2.Baseline, Week 2, Week 4, Week 6, Week | 12. | 3.Baseline, Week 2, Week 4, Week 6, Week | 12 | chronologically.

score from baseline to day 30.

时间窗: 1. Baseline (Day 0), Week 6 (end of treatment | plus or minus 3 days). | 2.Baseline, Week 2, Week 4, Week 6, Week | 12. | 3.Baseline, Week 2, Week 4, Week 6, Week | 12 | chronologically.

2.Shoulder ROM (abduction, flexion, external

时间窗: 1. Baseline (Day 0), Week 6 (end of treatment | plus or minus 3 days). | 2.Baseline, Week 2, Week 4, Week 6, Week | 12. | 3.Baseline, Week 2, Week 4, Week 6, Week | 12 | chronologically.

rotation) using goniometer.

时间窗: 1. Baseline (Day 0), Week 6 (end of treatment | plus or minus 3 days). | 2.Baseline, Week 2, Week 4, Week 6, Week | 12. | 3.Baseline, Week 2, Week 4, Week 6, Week | 12 | chronologically.

3.VAS (Visual Analogue Scale) for pain at rest

时间窗: 1. Baseline (Day 0), Week 6 (end of treatment | plus or minus 3 days). | 2.Baseline, Week 2, Week 4, Week 6, Week | 12. | 3.Baseline, Week 2, Week 4, Week 6, Week | 12 | chronologically.

and on movement.

时间窗: 1. Baseline (Day 0), Week 6 (end of treatment | plus or minus 3 days). | 2.Baseline, Week 2, Week 4, Week 6, Week | 12. | 3.Baseline, Week 2, Week 4, Week 6, Week | 12 | chronologically.

次要结局

未报告次要终点

研究者

发起方
Dr. Gaurav Prakash Londhe
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Gaurav Prakash Londhe

RA Podar Medical College.

研究点 (1)

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