Effect of Trandermal Magnesium on Sleep quality and Patients perception of change among adults with persistent neck pain- A randomzied controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pressure pain threshold using Algometer
研究概览
简要总结
The randomized controlled trial (RCT) investigated the impact of transdermal magnesium supplementation on both sleep quality and patients’ perception of change among adults experiencing persistent neck pain. The study aimed to address an area of clinical interest, recognizing the potential benefits of magnesium in managing both pain and sleep disturbances. Participants will be randomly assigned to either the experimental group, receiving transdermal magnesium supplementation, or the control group. Over the course of the trial, the experimental group applied transdermal magnesium spray (10 sprays) regularly, while the control group will receive standard physiotherapy care. Sleep quality and patients’ perception of change were evaluated using PSI.
The findings of the RCT shed light on the potential efficacy of transdermal magnesium supplementation in improving sleep quality and alleviating neck pain among adults with persistent neck pain. By incorporating patients’ perception of change, the study provided a holistic understanding of the intervention’s impact on individuals’ subjective experiences and overall well-being.
This research will contribute to the growing body of evidence supporting the role of magnesium supplementation in managing chronic pain conditions and associated sleep disturbances. Furthermore, it underscores the importance of considering patient-reported outcomes alongside objective measures in assessing treatment efficacy and enhancing patient-centered care strategies. Further studies may delve deeper into the mechanisms underlying the observed effects and explore optimal dosing regimens for transdermal magnesium supplementation in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Persistent Neck Pain duration more than 3 months.
- •Health Status: Individuals without diagnosed medical conditions affecting magnesium metabolism or utilization.
- •Ability to Provide Informed Consent: Participants must be capable of understanding the study procedures and providing informed consent.
- •Availability: Participants must be available for the duration of the study and willing to adhere to the intervention protocol.
排除标准
- •Known Magnesium Deficiency: Individuals with diagnosed magnesium deficiency or receiving magnesium supplementation at the time of enrollment.
- •Chronic Medical Conditions: Participants with chronic medical conditions (e.g., renal disease, gastrointestinal disorders) known to affect magnesium absorption or metabolism.
- •Medication Use: Individuals currently taking medications known to interfere with magnesium absorption or metabolism (e.g., proton pump inhibitors, diuretics).
- •Pregnancy or Lactation: Pregnant or lactating individuals, as magnesium requirements may differ during these periods.
- •Allergy or Sensitivity: Individuals with known allergies or sensitivities to magnesium or any components of the supplementation product (e.g., Spray 10 spray).
- •Participation in Other Clinical Trials: Participants currently enrolled in or have participated in other clinical trials within a specified timeframe prior to enrollment.
结局指标
主要结局
Pressure pain threshold using Algometer
时间窗: Baseline, 6 weeks and 12 weeks
The Petersberg Sleep Quality Index
时间窗: Baseline, 6 weeks and 12 weeks
Patient Global Perception of Change questionnaire
时间窗: Baseline, 6 weeks and 12 weeks
次要结局
- Neck Disability Index will be used to assess the degree of disability & limitations experienced by individuals suffering from neck pain.
研究者
Dr Mohammad Sidiq
Galgotias University