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

Not Applicable

Completed

• Conditions: Hemodialysis Complication
• Interventions: Other: Acupressure; Device: Transcutaneous electrical nerve stimulation

• Registration Number: NCT06098443
• Lead Sponsor: Cairo University

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-24
• Study Start: 2023-11-28
• Status Verified: 2023-12
• Primary Completion: 2024-01-30
• Study Completion: 2024-04-22
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• • 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 29.9.
  • 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupressure	Acupressure	The acupressure points will be determined, patients are informed that they will feel soft vibrations and pain during acupressure application. Patients are advised that it is sufficient for them to feel the vibrations of the acupressure device slightly. It be felt first symmetrically right knee, right leg, left knee, left leg Patients will receive acupressure 24 sessions three times a week for eight weeks. After application the patient will be asked about the severity of pain half an hour after administration (Çevik \& Taşcı, 2020).
Transcutaneous electrical nerve stimulation	Transcutaneous electrical nerve stimulation	• Placement electrodes applied on the painful area lower leg. Settings: * Intensity up to patient tolerance. * Duration 30min.

Primary Outcome Measures

Name	Time	Method
Pain pressure algometry:	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):	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):	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

Secondary Outcome Measures

Name	Time	Method
Patient health questionnaire PHQ-9:	Patient health questionnaire PHQ-9:will be measured at baseline, and it will be measured again after eight weeks	Patient health questionnaire PHQ-9: Is a nine-item questionnaire designed to screen depression in primary care and other medical settings
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	The incremental shuttle walking test (ISWT):Is an important marker of aerobic capacity in patients on renal dialysis

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt