跳至主要内容
临床试验/CTRI/2024/11/076764
CTRI/2024/11/076764尚未招募不适用

Comparison of USG guided platelet rich plasma Injection to corticosteroid injection in treatment of shoulder impingement

Guru Teg bahadur Hospital, University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月2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
30
试验地点
1
主要终点
1. Change from baseline of severity of symptoms and functional status using QDASH questionnaire

研究概览

简要总结

Shoulder impingement syndrome is most common cause of chronic shoulder pain

often causing limitation in range of movement at the shoulder joint. Shoulder’s

extreme mobility makes these symptoms cause great stress to the patient leading to

decreased quality of life. Rest, NSAIDs and physiotherapy have long been considered

the standard therapies in the majority of cases. However, there are limited treatment

options for the patients who are refractory to these conventional treatments and their

daily life activities are hindered due to the chronicity of symptoms. Corticosteroid

injections with their anti inflammatory effects have been used in such cases for short

term relief but it has some inherent disadvantages such as no long term effects,

infection, tendon ruptures, fat atrophy, etc. So there is need of newer agents that can

provide long-term effects and fewer side effects. Platelet rich plasma is a new

biological agent that has low side effects and can promote healing/regeneration. This

study aims to evaluate the effects of platelet rich plasma administered under USG

guidance and compare its efficacy in the treatment of such patients with shoulder

pathologies who are refractory to conventional treatment against old guard

recommendation of corticosteroids.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
19.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Adult patients having clinically diagnosed/suspected shoulder pathologies with refractory/recurrent pain and functional deficit for more than 2 months not resolving with conservative treatments i.e. NSAIDs and physiotherapy.

排除标准

  • • Pregnant patients • Patients having other causes of shoulder pain such as adhesive capsulitis, full thickness rotator cuff tears, major trauma, recurrent dislocations, osteoarthritis, inflammatory joint disease, cervical radiculopathy, thoracic outlet syndrome and bone tumors/ other malignancy at shoulder joint.
  • • Patients already diagnosed with neuromuscular disease or muscle disease.
  • • Patients with underlying coagulopathies, thrombocytopenia or taking anti-coagulant medications or having pace-maker.
  • • Patients with local site infection or localised dermatological condition.
  • • Patients who have recieved prior corticosteroid injection or have taken NSAIDs in last week(relative contra-indication).
  • • Patients who have undergone arthroscopic or open surgery of the affected shoulder, back or neck or have metallic implants in situ in the affected shoulder.

结局指标

主要结局

1. Change from baseline of severity of symptoms and functional status using QDASH questionnaire

时间窗: Evaluation will be done at baseline, 6 weeks and 12 weeks

in the two groups.

时间窗: Evaluation will be done at baseline, 6 weeks and 12 weeks

2. Change from baseline of pain using Visual Analogue Scale (VAS) in the two groups.

时间窗: Evaluation will be done at baseline, 6 weeks and 12 weeks

3. Change from baseline of range of movements using goniometer in the two groups.

时间窗: Evaluation will be done at baseline, 6 weeks and 12 weeks

4. Comparison of the improvement between the two groups.

时间窗: Evaluation will be done at baseline, 6 weeks and 12 weeks

次要结局

  • 1. Comparison of improvement of quality of life after the completion of the treatment in both(groups using WORC.)

研究者

发起方
Guru Teg bahadur Hospital, University of Medical Sciences
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rohit Krishna Dev

Guru Teg Bahadur hospital, University of medical sciences, new delhi

研究点 (1)

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