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临床试验/NCT06610032
NCT06610032已完成不适用

The Comparison O the Efficacy of Mesotherapy and Intra-articular Steroid Injection in Patients with Chronic Shoulder Pain

Haydarpasa Numune Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
VAS (Visual Analouge Scale)

研究概览

简要总结

Patients with chronic shoulder pain will be divided randomly into mesotherapy and intra-articular steroid injection groups. Pain severity, range of motion and functional impairment will evaluated before treatment, 30 minutes and 4 weeks after the injections.

详细描述

The study will include 84 patients aged 18-75 who applied to physical medicine and rehabilitation out-patient clinic with chronic shoulder pain between May and July 2024. Patients will be randomly divided into two groups: a mesotherapy group and steroid injection group, using the closed-envelope method. In the first group, a total of 3 sessions of mesotherapy are applied to the shoulder areas of the patients, 7 days apart. A single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered for patients in group 2. Pain severity, range of motion and functional impairment will evaluated before treatment, 30 minutes and 4 weeks after the injections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having shoulder pain for 6 months
  • VAS (Visual Analog Scale) > 4
  • Patients who can receive verbal instructions and do not have cognitive deficits

排除标准

  • Physical therapy applied to the shoulder area in the last 3 months
  • Having had a shoulder joint injection in the last 3 months
  • History of previous upper extremity surgery
  • History of drug allergy
  • Use of anticoagulant drugs (warfarin, low molecular weight heparin), patients with coagulation disorder
  • History of malignancy
  • Psychiatric illness
  • A rheumatological diagnosis such as Polymyalgia Rheumatica, Rheumatoid Arthritis, Ankylosing Spondylitis
  • Kidney failure
  • Liver disease
  • Heart failure
  • Presence of infection, wound, allergy, burn-like lesions in the application area

结局指标

主要结局

VAS (Visual Analouge Scale)

时间窗: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.

Pain Severity evaluation ((0 (no pain)-10 (unbearable pain))

Shoulder Disability Questionnaire' (OSS) form

时间窗: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.

Functional Disability evaluation (0-100)

Goniometric shoulder range of motion

时间窗: Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.

shoulder range of motion evaluation

次要结局

未报告次要终点

研究者

发起方
Haydarpasa Numune Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ecem Pelin Kaymaz

Medical Doctor of Physical Medicine and Rehabilitation

Haydarpasa Numune Training and Research Hospital

研究点 (2)

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