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临床试验/NCT06098443
NCT06098443已完成不适用

Acupressure Versus Transcutaneous Electrical Nerve Stimulation on Pain and Quality of Life Intradialysis

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Pain pressure algometry:

研究概览

简要总结

Hemodialysis patients have a high prevalence of pain, mainly musculoskeletal and intra dialytic pain. A high prevalence of pain was also observed in the upper and lower limbs and the trunk. In addition, severe functional interference of pain in the ability to walk was associated with pain in the upper Limb. These results indicate that pain in hemodialysis patients is limiting and disabling (Dos Santos et al., 2021).

Acupressure increases relaxation, relieves pain, and reduces anxiety and depression, especially in the elderly. It is relatively inexpensive, safe, non-invasive, and easy to use and is performed by hands, elbows. by applying pressure to specific areas of the body so muscle spasms are relieved, blood circulation and vital energy are improved (Bastani et al.,2022).

Strong non-painful TENS within or close to the site of pain produces clinically important reductions in the intensity of pain during or immediately after treatment. With no reports of serious adverse events. TENS as an adjunct to core treatment or immediate short-term relief of pain, irrespective of diagnosis. Patients should be advised to tailor TENS Treatment according to their individual needs (Johnson et al., 2022).

详细描述

Sixty patients will be randomly assigned into two equal groups (n=30):

  1. Group A (30 patients) will receive Acupressure three times per week for eight weeks.
  2. Group B (30 patients) will receive TENS three times per week for eight weeks.

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
50 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • • Sixty patients with renal failure stage 5 undergoing hemodialysis sessions at least six months ago up to 2 years.
  • Participants with lower limb pain and brief pain inventory (BPI) pain score between 7 and 10 points.
  • Body mass index ranges from 25 to 29.
  • Their ages range from 50-60 years old.
  • All patients will be under full medical control.
  • Patients will be free from lower limb dialysis grafting.
  • Hemoglobin level more than 10 mg\dl.

排除标准

  • Skin disease such as dermatitis, stitches and wound.
  • Active infection, autoimmune diseases and malignancy.
  • Severe cardiac diseases.
  • Severe chest diseases.
  • Patients with cardiac pacemaker.
  • Epilepsy.
  • Using another integrative treatment method during the study.
  • Uncontrolled diabetes.
  • Deep vein thrombosis.
  • Lumber disc prolapses affect lower limb.

结局指标

主要结局

Pain pressure algometry:

时间窗: Pain pressure algometry:will be measured at baseline, and it will be measured again after eight weeks

Pain pressure algometry: Device to measure the intensity of painful stimuli objectively

The Brief Pain Inventory (BPI):

时间窗: The Brief Pain Inventory (BPI): will be measured at baseline, and it will be measured again after eight weeks

The Brief Pain Inventory (BPI): Is a multidimensional pain assessment tool used to evaluate pain severity and pain interference. The BPI has been translated and validity estimated across multiple languages and patient populations for clinical and research settings.

Short form -36 questionnaire (KDQoL SF-36):

时间窗: Short form -36 questionnaire (KDQoL SF-36):will be measured at baseline, and it will be measured again after eight weeks

Short form -36 questionnaire (KDQoL SF-36): Is generic measure of health that has also been used widely in trials in hemodialysis patients for the objective measure quality of life

次要结局

  • Patient health questionnaire PHQ-9:(Patient health questionnaire PHQ-9:will be measured at baseline, and it will be measured again after eight weeks)
  • The incremental shuttle walking test (ISWT):(The incremental shuttle walking test (ISWT):will be measured at baseline, and it will be measured again after eight weeks)

研究者

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

Alaa Mohamed El-Moatasem Mohamed

lecturer of physical therapy

Cairo University

研究点 (2)

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