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临床试验/NCT05370833
NCT05370833Unknown不适用

Observation et Analyse Des Effets de la Stimulation transcrânienne à Courant Continu en Milieu Clinique Pour Soulager la Douleur Chronique Chez Les Travailleurs Vieillissants

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

Chronic pain is one of the main factors influencing workers' retention at work. Considering that the prevalence of suffering from chronic pain increases with age, older workers are most likely to be absent from work because of their pain.

Transcranial direct current stimulation (tDCS) is a treatment option to reduce chronic pain.

This study aims to document the effect of tDCS on pain and work retention in older workers and to compare the traditional tDCS protocol (5 sessions) with an enhanced protocol (11 sessions).

详细描述

Chronic pain affects many spheres of the lives of affected individuals and those around them. In Canada, the prevalence of chronic pain is estimated at 15% of adults aged 18 and over. Among seniors, the prevalence of this health problem can reach up to 50% and affect one in two seniors. Chronic pain is one of the leading causes of work disability. In this context, pain reduction remains one of the most effective methods to enable the worker to stay at work. Considering the aging Quebec population, labor needs and the average retirement age which is increasingly postponed, it becomes crucial to take an interest in aging workers and their continued employment.

Transcranial direct current stimulation (tDCS) is a non-invasive neurostimulation method that has shown promise in reducing chronic pain. Recently, several research teams have shown that tDCS has beneficial effects on pain, physical function and social participation in seniors. Despite all these recent advances, very few studies have focused on optimizing tDCS treatment modalities and no studies have focused on the impact of tDCS on return to work or retention. The vast majority of studies using tDCS to reduce pain give one tDCS session per day for 5 consecutive days. This study aims to document the effect of tDCS on pain and work retention in older workers and to compare the traditional tDCS protocol (5 sessions) with an enhanced protocol (11 sessions).

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
56 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •To be more than 55 years old
  • •To have chronic pain
  • •To have employment relationship
  • •To have pain that interferes with work tasks

排除标准

  • •- tDCS contraindications (epilepsy, metallic implant in the head, pacemaker, cochlear implant)

研究组 & 干预措施

Standard protocol

Experimental

5 tDCS sessions in 1 week

干预措施: transcranial direct current stimulation (Device)

Enhanced protocol

Experimental

11 tDCS sessions devised in 4 weeks

干预措施: transcranial direct current stimulation (Device)

结局指标

主要结局

Pain intensity

时间窗: 4 weeks after the last tDCS session

0-10 Numerical rating scale

Disability

时间窗: 4 weeks after the last tDCS session

Pain Disability Index

Depression

时间窗: 4 weeks after the last tDCS session

Beck depression inventory

Impression of change

时间窗: 4 weeks after the last tDCS session

Patient Global impression of change

Work role functioning

时间窗: 4 weeks after the last tDCS session

Work Role Functioning Questionnaire

Physical Functioning

时间窗: 4 weeks after the last tDCS session

Brief Pain Inventory

Anxiety

时间窗: 4 weeks after the last tDCS session

Beck anxiety inventory

Central sensitization

时间窗: 4 weeks after the last tDCS session

central sensitization inventory

Disability

时间窗: 4 weeks

Pain Disability Index

Anxiety

时间窗: Before tDCS

Beck anxiety inventory

Anxiety

时间窗: 1 week

Beck anxiety inventory

Pain intensity

时间窗: Before tDCS

0-10 Numerical rating scale

Pain intensity

时间窗: 1 week

0-10 Numerical rating scale

Pain intensity

时间窗: 4 weeks

0-10 Numerical rating scale

Disability

时间窗: Before tDCS

Pain Disability Index

Disability

时间窗: 1 week

Pain Disability Index

Work role functioning

时间窗: Before tDCS

Work Role Functioning Questionnaire

Work role functioning

时间窗: 1 week

Work Role Functioning Questionnaire

Work role functioning

时间窗: 4 weeks

Work Role Functioning Questionnaire

Physical Functioning

时间窗: Before tDCS

Brief Pain Inventory

Physical Functioning

时间窗: 1 week

Brief Pain Inventory

Physical Functioning

时间窗: 4 weeks

Brief Pain Inventory

Anxiety

时间窗: 4 weeks

Beck anxiety inventory

Depression

时间窗: Before tDCS

Beck depression inventory

Depression

时间窗: 1 week

Beck depression inventory

Depression

时间窗: 4 weeks

Beck depression inventory

Impression of change

时间窗: 1 week

Patient Global impression of change

Impression of change

时间窗: 4 weeks

Patient Global impression of change

Central sensitization

时间窗: Before tDCS

central sensitization inventory

Central sensitization

时间窗: 1 week

central sensitization inventory

Central sensitization

时间窗: 4 weeks

central sensitization inventory

次要结局

  • Recruitment(through study completion, about 2 years)
  • Security(through study completion, about 2 years)
  • Intervention(through study completion, about 2 years)

研究者

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

Guillaume Léonard

Professor

Université de Sherbrooke

研究点 (2)

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