A Pilot Randomised Controlled Feasibility Trial for the Use of a Pulsed Electromagnetic Field Device to Assist Management of Type 2 Diabetes
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
- Change in score of the Appraisal of Diabetes Scale (ADS)
研究概览
简要总结
The majority of people with diabetes worldwide consist of type 2 diabetes mellitus. Typically, patients with type 2 diabetes are encouraged to manage their condition with weight loss; healthy eating; regular exercise; blood glucose monitoring; and in some cases, diabetes medication or insulin therapy. However, many struggle with their condition.
Pulsed Electromagnetic Frequency (PEMF) devices, which follow similar principles as a TENS machine, emit electromagnetic fields and are proposed to provide a non-invasive, safe, and easy-to-use method for treatment and management of diabetes related symptoms such as pain, alongside existing treatments and interventions. There is a belief that such devices may promote health and wellbeing and as a result could improve outcomes of type 2 diabetes. The use of the PEMF device would not replace existing treatments, interventions, or any primary care that the participants are currently receiving.
The purpose of this study is to evaluate the effectiveness of a PEMF device of this kind for reported symptoms such as pain, fatigue, and overall wellbeing in people with type 2 diabetes. The study also seeks to explore patients' experiences of using the PEMF device.
详细描述
Type 2 diabetes is highly prevalent and many sufferers struggle with their condition. One symptom of type 2 diabetes is diabetic neuropathy, which is characterised by progressive pain and loss of sensation.
Pulsed Electromagnetic Frequency (PEMF) devices, which follow similar principles as a TENS machine, emit electromagnetic fields and are proposed to provide a non-invasive, safe, and easy-to-use method for treatment and management of pain alongside existing treatments and interventions. A recent systematic review reported that pulsed electromagnetic fields had high efficacy in reducing musculoskeletal pain and that methods were well tolerated and had no negative side effects. Research established that pulsed electromagnetic field therapy had beneficial effects on pain, stiffness, and physical function in patients with osteoarthritis. It has, however, been recommended that further research is conducted to examine the use and effectiveness of pulsed electromagnetic field methods.
Given the findings reported regarding the effectiveness of pulsed electromagnetic field methods in reducing pain, it is possible that such devices could prove effective in managing diabetes related symptoms such as pain. It would also be useful to provide insight on the claim that they could potentially improve outcomes of type 2 diabetes and benefit users overall wellbeing.
The study is a pragmatic study as it is considered a better reflection of the perceived clinical benefits in a real world setting as opposed to being more efficacious in a trial setting. Pragmatic studies answer questions such as whether there is perceived additional clinical benefit where a treatment is utilised alongside usual care. This can then determine whether there is reason to explore this matter further and conduct a placebo-controlled trial to further inform health professionals and clinical guidelines.
The purpose of this study, therefore, is to evaluate the effectiveness of a pulsed electromagnetic field (PEMF) device for managing pain, health and wellbeing issues associated with type 2 diabetes via a pragmatic study. The study also seeks to explore patients' experiences of using the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years, of any gender.
- •Consulted at their general practice for type 2 diabetes in the previous 12 months.
- •Residing within England (due to delivery difficulties from covid-19).
- •Self-reported confirmed diagnosis of type 2 diabetes.
- •Self-reported stable medication regime for diabetes for at least one month.
- •Sufficient command of English to complete questionnaires.
- •Patients willing to participate in the study and be randomised into one of the two study groups.
排除标准
- •Patients with type 1 diabetes.
- •Patients with previous experience of using PEMF devices.
- •Patients residing outside England.
- •Patients with electronic implants such as pacemakers.
- •Patients with an electro-cardio implant.
- •Patients who have any electronic heart or lung apparatus.
- •Patients who are pregnant.
- •Patients who have a malignant tumour.
- •Patients who are receiving high-level treatment.
- •Patients who have a life-threatening illness.
结局指标
主要结局
Change in score of the Appraisal of Diabetes Scale (ADS)
时间窗: Baseline and at the end of the 3 months
Appraisal of Diabetes Scale (ADS): The ADS is a brief 7-item patient-reported scale that assesses the impact of diabetes on a patient's life. The items, which were developed based on theory and previous research, include "How upsetting is having diabetes for you?" and "To what degree does your diabetes get in the way of your developing life goals?". The instrument has been shown to have acceptable internal consistency reliability, test-retest reliability, and construct validity. Higher scores indicate greater negative impact of diabetes.
Change in Measure Yourself Medical Outcome Profile (MYMOP)2 score
时间窗: Baseline and at the end of the 3 months
MYMOP2 is a validated questionnaire where patients can express their any two concerns and rate them
Change in the EQ-5D-5L tool score
时间窗: Baseline and at the end of the 3 months
EQ-5D-5L: Health related quality of life (HRQoL) will be measured using the EQ-5D-5L, which contains five indices to represent patients' HRQoL on the day of completing the form: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. The EQ-5D-5L also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL. The EQ-5D-5L is well validated and numerous studies have used the EQ-5D-5L in a variety of patient populations, including diabetes.
次要结局
未报告次要终点
研究者
Anne Majumdar
Research Administrator
St Mary's University College