跳至主要内容
临床试验/NCT03142386
NCT03142386已完成不适用

Pain and Quality of Life Management in Oncology Geriatric Patients With Osteopathic Manipulative Treatment: a Pilot Study

Fondazione Don Carlo Gnocchi Onlus0 个研究点目标入组 23 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
主要终点
Pain

研究概览

简要总结

The aim of present study was to study the osteopathic manipulative effects on pain relief and quality of life improvement on hospitalized oncology geriatric patients. A non-randomized comparison trial was performed in Unit of Oncology Rehabilitation, Palazzolo Institute, Don Carlo Gnocchi Foundation ONLUS, Milan, Italy, from September 2015 to March 2016. 23 older oncology patients were unrolled and allocated in two experimental groups: study group (OMT group, N=12) underwent to osteopathic manipulative treatment associated to physiotherapy and control group (PT group, N = 11) underwent only physiotherapy. At enrollment (T0), 23 recruited oncology patients completed the socio-demographic forms and were evaluated, from external examiner, pain intensity and quality of life. All patients were revaluated at the end of treatment (T4) for quality of life and every week (T1, T2, T3 and T4) for pain intensity. Standard level of significance was p<0.05.

研究设计

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

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • oncology patients
  • male and female
  • age≥65 years
  • with a clinical prognosis of 6-24 months
  • diagnosis of multifactorial hyperkinetic syndrome (i.e. metastatic surgery)
  • pain intensity score higher than 3, measured with Numeric Rating Scale (NRS)

排除标准

  • patients were receiving chemotherapy or radiotherapy treatment at the time of the study
  • with mental disorders (MMSE<10)
  • the presence of infection
  • anticoagulation therapy
  • cardiopulmonary disease
  • clinical instability post-surgery.

结局指标

主要结局

Pain

时间窗: Once a week for a total 4 weeks

Numeric Rating Scale (NRS) is a validated scale to measure the intensity of pain, with numbers between 0 and 10, with 0 representing absence of pain and 10 the worst possible pain experienced by the patient.

次要结局

  • Quality of life(At baseline and up to 4 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chiara Arienti

PhD

Fondazione Don Carlo Gnocchi Onlus

相似试验