Using Peripheral Neurostimulation to Improve Work Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Exclusion rate
研究概览
简要总结
Physical exercise plays a central role in work rehabilitation. However, the presence of pain (particularly common in older adults and aging workers) can lead to a fear of movement (kinesiophobia) and hinder rehabilitation. Access to rehabilitation care is also a barrier for many older adults, which could be circumvented through telerehabilitation. The objective of this pilot study is to document the feasibility and explore the effect of a telerehabilitation intervention combining therapeutic exercises and real TENS (experimental group) or placebo TENS (control group) in individuals aged 55 and over who have stopped working (triple-blind randomized controlled study). To do so, various feasibility indicators (e.g., recruitment rate, adherence) and clinical measures (e.g., kinesiophobia, pain during exercise) will be documented before and after the intervention. Together, these measures will help assess the appropriateness of conducting a large-scale study aimed at potentiating work rehabilitation in older populations.
详细描述
Problem and hypotheses:
In 2019, the proportion of Canadians aged 55 and over who were employed was 35.9%, the highest rate recorded to date since 1976. Despite their willingness to remain employed, seniors are more prone to work disability and early retirement. Older workers with disabilities are particularly vulnerable to job retention. In Quebec, the average length of absence following a work-related injury is 134 days for workers aged 55 and over, while it is less than 50 days for those aged 15 to 24. This difference can be explained in part by the presence of persistent pain that disproportionately affects older individuals and can significantly impede rehabilitation to work. The indirect costs associated with unemployment and absenteeism of people living with chronic pain were estimated to be $22.5 billion in Canada in 2019. A recent review conducted and published by our team found that strategies to reduce pain are one of the most important elements to consider in enabling workers to remain in the workplace after an episode of musculoskeletal disorder.
Exercise plays a central role in chronic pain management and work rehabilitation. However, pain can be a major barrier to physical activity. Therefore, finding ways to reduce pain during and after exercise is essential to facilitate rehabilitation. Peripheral neurostimulation (TENS) - an electrotherapeutic modality that uses an electrical current to depolarize peripheral nerve fibers with electrodes applied directly to the skin - is effective in temporarily relieving pain. It represents an interesting avenue for increasing exercise tolerance associated with exercise in the pain subject. To date, 3 studies have investigated the use of TENS during exercise, all showing positive results. None, however, have yet investigated this strategy (TENS + exercise) in aging workers living with persistent pain.
We postulate that telerehabilitation treatments (therapeutic exercises) provided concurrently with actual TENS will be more effective in reducing the biopsychological impacts of pain than the same rehabilitation treatments paired with placebo TENS. Thus, our hypothesis is that the experimental treatment will cause participants to enter a "virtuous circle": the TENS will allow for a punctual reduction of pain and kinesiophobia, which will encourage the realization/resumption of activity and lead to sustained benefits (e.g., physical function, pain, mood).
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple blind
入排标准
- 年龄范围
- 55 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 55 years of age or older
- •Being off work completely due to a musculoskeletal injury
- •Starting a physical rehabilitation program
- •Being in employment
- •Experiencing pain of mild intensity (score of 1-3 points on a numerical scale of 0-10 points) to moderate intensity (score of 4-6 points) during movements/exercises
- •Being comfortable enough with technology to participate in video conferences, respond to emails or text messages
- •Having stable medication and lifestyle habits
- •Speaking French
排除标准
- •Having a cognitive deficiency
- •Wearing a cardiac defibrillator or pacemaker
- •Being diagnosed with cancer
- •Having already experimented with TENS
结局指标
主要结局
Exclusion rate
时间窗: 4 months
The number of ineligible participants divided by the number of participants screened.
Adherence rate
时间窗: 3 weeks
The number of people who finished intervention divided by the number of participants randomized.
Attrition rate
时间窗: 3 weeks
The number of people who did not finish intervention divided by the number of participants randomized.
Recruitment rate
时间窗: 4 months
The number of participants randomized divided by the number of participants screened.
Refusal rate
时间窗: 4 months
The number of participants who refused to participate in the trial divided by the number of participants screened.
Kinesiophobia
时间窗: 3 weeks
excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability due to painful injury or reinjury - Measured with the Tampa scale of kinesiophobia
次要结局
- Psychosocial component and impact of pain on the emotional sphere(3 weeks)
- Qualitative component of pain(Intervention period (before first and after last sessions))
- Severity of pain and impact of pain on physical function(3 weeks)
- Pain intensity(3 weeks)
- Overall treatment satisfaction(3 weeks)
- Pain catastrophizing(3 weeks)
- Disability in work Rehabilitation(3 weeks)
- Quality of movement(3 weeks)
研究者
Guillaume Léonard
Professor
Université de Sherbrooke
