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

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).

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication
• Intervention / Treatment: Other: Acupressure; Device: Transcutaneous electrical nerve stimulation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Acupressure; Acupressure is effective on anxiety and depression management. acupressure therapy at K1, ST36, and SP6 acupoints significantly reduced anxiety & depression in patients with ESRD.
Active Comparator: Transcutaneous electrical nerve stimulation; • Placement electrodes applied on the painful area lower leg. Settings: Intensity up to patient tolerance.; Duration 30min.	Device: Transcutaneous electrical nerve stimulation; TENS lead to meaningful reduction of pain in patients suffering from difficult to treat phantom limb pain. This treatment has a high success rate and is associated with high satisfaction rates and no reported adverse events. The suggested duration of treatment is at least 30 minutes and may be extended up to 45 minutes. TENS delivers pulsed electric currents across the intact surface of the skin to stimulate peripheral nerves and the spinal cord, resulting in segmental and extra segmental analgesia. TENS delivers pulsed electric currents across the intact surface of the skin to stimulate peripheral nerves and the spinal cord, resulting in segmental and extrasegmental analgesia. (Vathakul et al., 2022).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain pressure algometry:	Pain pressure algometry: Device to measure the intensity of painful stimuli objectively	Pain pressure algometry:will be measured at baseline, and it will be measured again after eight weeks
The Brief Pain Inventory (BPI):	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.	The Brief Pain Inventory (BPI): will be measured at baseline, and it will be measured again after eight weeks
Short form -36 questionnaire (KDQoL SF-36):	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	Short form -36 questionnaire (KDQoL SF-36):will be measured at baseline, and it will be measured again after eight weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Hany Obaya, assistant professor, giza, Egypt, 12511

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): April 22, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: P.T.REC/012/004482

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes