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临床试验/NCT02736851
NCT02736851已完成不适用

Home-Based Telemedicine Management of Patients Affected by Chronic Neck Pain

Fondazione Salvatore Maugeri0 个研究点目标入组 94 人开始时间: 2009年1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
94
主要终点
Change in Adherence as assessed by number of exercise sessions/week

研究概览

简要总结

The aim of the study is to investigate if a home-based structured physician-directed, nurse-managed telemedicine program can increase adherence to a home exercise program and decrease neck pain and disability.

The study is carried out in 100 consecutive patients with chronic non-specific neck pain.

All patients referred to a rehabilitation Institute for an out-.patient visit complete a stretching exercise program and are instructed and encouraged to perform exercises regularly once at home. At the end of the rehabilitation, the patients are randomized into two groups of 50 patients each. Patients of the first Group are allocated to a home-based telemedicine (HBT), while those of the second group receive only the recommendation to continue exercising at home (Control group). The HBT intervention consists of fortnightly scheduled phone calls to patients over the 6-month course of the study. A nurse-tutor encourages the patient to perform regularly physical activity and prescribes exercises.

Adherence to home exercises is evaluated 15 days and 6 months after the end of the outpatient rehabilitation, while pain intensity and neck disability are assessed and compared in the two groups at entry and 6 months after the end of the outpatient rehabilitation .

详细描述

Systematic reviews have concluded that exercises taught individually and prescribed to be performed at home, are effective in decreasing neck pain and avoiding recurrence of neck pain (re-exacerbations) if patients adhere to the home exercise program. Conversely, inadequate adherence to a home-based exercise program reduces the treatment's efficacy. Telemedicine is already employed in many fields of medicine to evaluate health status, treatment, education, and to monitor patients' care needs but not in management of the patients with chronic neck pain. Studies available in the literature have not yet clearly defined if a phone surveillance program is effective in decreasing pain in these patients. Conversely, we think that telemedicine may be a useful tool for physicians in management of chronic neck pain because it can increase adherence to home exercises program thus reducing neck pain and disability in these patients. To verify this hypothesis we perform this prospective randomized controlled study.

The study is performed in 100 consecutive patients with chronic non-specific neck pain referred to the outpatient facility of our Rehabilitation Department.

Patients have to be > 18 years and with neck pain duration more than 6 months. Exclusion criteria are: pain duration < 6 months, cognitive deficit, history of fracture or operations around the neck region, presence of inflammatory rheumatic diseases, neurological diseases that could lead to neck pain, infections or tumors, pregnancy, previous rehabilitation for neck pain undergone within the last 12 months, and inability to attend all exercise sessions of our outpatient rehabilitation program.

All patients have to complete, as outpatients, an exercise program consisting of 10 sessions, spread over a 2-week period (5 days/week), and including six stretching exercises for the neck.

Patients are instructed individually by a physical therapist on how to perform each exercise and, after the first rehabilitation session, are encouraged to exercise regularly at home. Written and illustrated material explaining the home exercises are provided to all patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • chronic non-specific neck pain duration more than 6 months.

排除标准

  • pain duration less than 6 months
  • willingness to sign the informed consent form (unable to read or write)
  • cognitive deficit (e.g. Alzheimer disease or senile dementia)
  • patient unable to attend all sessions of exercises
  • inflammatory rheumatic diseases
  • history of fracture or operations around the neck region
  • neurological diseases that may lead to neck pain, infections or tumours
  • pregnancy
  • rehabilitation sessions for neck pain since less than 12 months.

结局指标

主要结局

Change in Adherence as assessed by number of exercise sessions/week

时间窗: Change between 15 days and 6 months after the end of the outpatient rehabilitation

Number of exercise sessions/week

次要结局

  • Change in Pain(Change between entry and 6 months after the end of the outpatient rehabilitation)
  • Change in Disability(Change between entry and 6 months after the end of the outpatient rehabilitation)

研究者

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

Bernardo Gialanella

Coordinator

Fondazione Salvatore Maugeri

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