Effects of Integrated Pranic Healing as Complementary Therapy on Pain management and Overall Wellbeing among patients with Peripheral Neuropathy in type 2 Diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Relieve in pain symptoms as per Neuropathic Pain Symptom
研究概览
简要总结
Diabetic peripheral neuropathy, a common complication of diabetes, significantly impairs quality of life due to sensory pain, motor dysfunction, and associated difficulties in daily activities. This condition affects up to 50% of diabetics, leading to complications such as foot ulcers and increased disability. Lifelong medication for diabetic peripheral neuropathy (DPN) often involves the use of drugs like Neuropathic Pain Agents to manage pain. While these medications can relieve pain and discomfort, they do not cure DPN or halt its progression. Additionally, long-term use may lead to tolerance, requiring higher doses to achieve the same effect, potentially increasing side effects. This study evaluates the effectiveness of integrated pranic healing (PH) as a complementary therapy for diabetic peripheral neuropathy (DPN). This study compares pranic healing combined with medical therapy (MEDPH) against medical therapy alone (MED) in terms of its impact on various outcomes. These include pain, psychological well-being, vibration perception threshold, functional health capacity, blood glucose level and temperature. Eligible participants will be recruited for the study according to specified inclusion and exclusion criteria and will be randomly assigned to one of two groups. One group will receive standard treatment along with Pranic Healing, while the other group will receive standard treatment alone. Both groups will undergo pre- and post-intervention assessments and analyse the collected data. Participant’s experiences with Pranic Healing will be explored through structured interviews, incorporating open-ended questions. Feedback will be analysed using qualitative content analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Participants must provide written informed consent to participate in the study.
- •Male and female participants aged between 30 and 60 years.
- •Subjects with a clinical diagnosis of Type 2 diabetes
- •Peripheral neuropathy diagnosed using Semmes-Weinstein Monofilament (SWM) Test and Biothesiometry:
- •Having a history of peripheral neuropathy from onset to 9 years.
排除标准
- •Subjects with other neurological conditions that affect hand function (e.g., stroke, multiple sclerosis, carpal tunnel syndrome, or someone with excessive alcoholic consumption (more than 21 units per week for men/ more than 15 units for women) will be excluded.
- •Subjects diagnosed with heart disease, renal failure with stage 3 and stage 4, severe hepatic disease, and diabetic foot ulcer.
- •Subjects with type 1 diabetes
- •Subjects with known vitamin B12 deficiency
- •Pregnant, and lactating women will be excluded.
- •Subjects with serious psychiatric disorders, or cognitive impairments that could affect their ability to follow the study protocol will be excluded.
- •Subjects who have had recent surgery or trauma affecting the extremities will be excluded.
- •Those who are participating in any other clinical trial or interventional study.
结局指标
主要结局
Relieve in pain symptoms as per Neuropathic Pain Symptom
时间窗: 0, 5 weeks
Inventory score
时间窗: 0, 5 weeks
次要结局
- reductions in scores of Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)(weeks)
- Reductions in worry scores using Penn State Worry Questionnaire(0, 5 weeks)
- Enhance in the score of Modified Diabetes Quality(of Life scale)
- Improvement in Vibration Perception Threshold based on Biothesiometry test(0, 5 weeks)
- Improved sensory nerve conduction velocity based on(mean score of Semmes-Weinstein Monofilament (SWM))
- Improved hand grip strength based on the mean score(of the TTM Original Dynamometer)
- reduction in FBS and PPBS(0, 5 weeks)
- Temperature balance in both feet(0, 5 weeks)
- An open-ended questionnaire will be used for interviews with participants from the Pranic Healing group. The interviews will be recorded, transcribed, and then analyzed.(5 weeks)
研究者
Manasa B
World Pranic Healing Foundation, India
