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临床试验/CTRI/2024/11/076163
CTRI/2024/11/076163尚未招募不适用

Clinical study of two different doses of dextrose as a drug for prolotherapy treatment in patients of osteoarthritis knee pain

Department of anaesthesiology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月15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
60
试验地点
1
主要终点
To evaluate the effects of two concentration of dextrose 10% and 25% for intraarticular injection in osteoaethritis knee pain.

研究概览

简要总结

- Prolotherapy is one of the  regenerative medicine treatment and  is an injection based  medical therapy for chronic musculoskeletal pain.

-It has been used for approximately 100 years;however,its modern application can be trace to the 1950s when the prolotherapy injection protocols were formalised by Dr George Hackett, a general surgeon in the united states,remembered as grandfather of prolotherapy.

-prolotherapy ,which stimulates the healing of loosened ligaments and tendons,is a cost effective and safe treatment modality for chronic musculoskeletal pain.

-The prolotherapy technique we use is called as comprehensive prolotherapy or HACKETT-HEMWALL-HAUSER (H3) Prolotherapy.

-A combination of dextrose solution and lidocain is usually used. The concentration of dextrose and lidocaine used in the clinical field are very high (Dextrose-10%to25% ,lidocaine -0.5% to 1%)

-Prolotherapy is the technique of injecting sterile irritants which stimulates physiological acute inflammatory cascade following promotion and Healing of damaged& repairable tissue.

|- Many passionate therapists call it a panacea for all ailments It is said to work by raising growth factor levels and increasing cellular proliferation, promoting healing in damaged ligaments. Proponents attribute all articular and periarticular pains to lax, injured or unhealthy ligaments. Prolotherapy can be used at any stage of the disease, and is also applicable to patients who are unwilling or unfit for surgery.

-Prolotherapy has been used in the U.S. for musculoskeletal pain since the 1930’s and is endorsed by numerous main stream practitioners.

-It has been reported in 2020 that over 2500,000 Americans had undergone prolotherapy and that many of the patients reporting benefits from prolotherapy were physicians themselves. Yet, many main stream medical practitioners have still not heard of or do not know much about prolotherapy.

-In Europe and asian countries, many millions of patients receive prolotherapy regularly and have been immensely benefited by the same.

|PROLOTHERAPY AGENT-1. Dextrose 10% -25%

  1. Lidocaine 0.5% - 1% without preservatives

·        This analytical Hospital-based study will be carried out at  Gandhi Medical College and Associated Hospital, Bhopal. This study will be conducted on all patients of American Society of Anaesthesiologist physical status I and II aged between 45-75 years

·        Written and informed consent, before participating in the study will be taken from all patients/attendants.

·        METHOD-In this study half of patients will be given 10%dextrose and other half 25% dextrose with fix dose 1% of lodocaine .

-3Injections will be given with interval of one week then will be followed up in 1month 3month& 6month.

-         Site of injection will be intraarticular .

-         8 ml dextrose with 2 ml lodocaine,2.5 -3 ml will be given at multiple site for injured tendon/ligament of osteoarthritis  knee joint.

Assessment will be done by  relieve in pain,range in mobility of joint ,distance of walking.

研究设计

研究类型
Observational

入排标准

年龄范围
45.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Age groups 45 years.
  • Patients of both SEX
  • ASA Grade I & II
  • OA knee grade II &III.

排除标准

  • Uncontrolled metabolic disease(DM2 ,Thyroid disease)
  • Patients with implants
  • Pregnancy
  • Know drug allergy
  • Cardiac diseases.

结局指标

主要结局

To evaluate the effects of two concentration of dextrose 10% and 25% for intraarticular injection in osteoaethritis knee pain.

时间窗: Outcome will be assessed at after the procedure,at 1month,3month,6month

次要结局

  • To determine the effectiveness of dextrose prolotherapy as long term treatment for chronic musculoskeletal knee pain(6 months)

研究者

发起方
Department of anaesthesiology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Gajendra singh Baghel

Gandhi Medical College, Bhopal

研究点 (1)

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