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临床试验/NCT04192162
NCT04192162Unknown不适用

Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis

Specialized Rehabilitation Hospital Banja Koviljaca2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年12月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
The serotonin levels

研究概览

简要总结

This study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the osteoarthritis patients, as well as water the application of exercise in water effects the results we receive.

详细描述

Sulfur baths and mud packs are known to have a positive effect in patients with osteoarthritis (OA). OA is a chronic degenerative disease accompanied by a constant pain that often leads to changes in the mood of patients. Over the last few decades, numerous articles reported various beneficial effects of sulfur water and peloid therapeutic applications. Serotonin is one of the important neurotransmitters that have numerous functions such as regulation of body temperature, sleep, appetite, while its main function is reflected in controling of depression.

The aim of this study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the OA patients, as well as whether the application of exercise in water effects the results we receive.

Randomized controlled study included patients with hip and/or knee OA both sexes, randomized into two groups. The first group patients underwent sulfur balneotherapy and mud pack therapy. Patients in the second group had sulfur balneotherapy, mud pack therapy and exercise in hygienic water. The duration of spa therapy program was 12 days. Serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy.

This study is expected to be another contribution to existing evidence and shed light on the mechanisms of beneficial effects of balneotherapy and mud therapy and whether addition underwater exercise would have extra therapeutic effects.

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
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages of 50 - 65 , both sexes
  • Patients diagnosed with hip and / or knee OA without having used balneotherapy in the previous year
  • Patients who have not changed their medication in the last 2 months
  • Patients who have not received injections into the hip and / or knee joint in the last 6 months (PRP, Diprofos...)

排除标准

  • Secondary hip and / or knee OA
  • Patients with MOA inhibitors, selective serotonin inhibitors, morphine, lithium and methyldopa in therapy
  • Visible disruption of hip and / or knee joint structures
  • Treatment of malignancy
  • Diseases of the heart, lungs, decompensated conditions of other organs, infections, active bleeding
  • Severe hip and / or knee joint injuries, fractures, and previous surgical procedures
  • Physical therapy, balneotherapy back one year

结局指标

主要结局

The serotonin levels

时间窗: Time Frame: Baseline vs. 12-days

Serotonin concentration

次要结局

  • Analysis of hemoglobin(Time Frame: Baseline vs. 12-days)
  • Marker of inflammation(Time Frame: Baseline vs. 12-days)
  • Analysis of red blood cell counts(Time Frame: Baseline vs. 12-days)

研究者

发起方
Specialized Rehabilitation Hospital Banja Koviljaca
申办方类型
Other
责任方
Sponsor

研究点 (2)

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