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Completed

NCT Number: NCT06098443

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).

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Key information

Conditions

Hemodialysis Complication

Age range

50 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11432, Egypt

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupressure

Other

Acupressure is effective on anxiety and depression management. acupressure therapy at K1, ST36, and SP6 acupoints significantly reduced anxiety & depression in patients with ESRD.

Transcutaneous electrical nerve stimulation

Device

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).

Primary outcomes

  1. Pain pressure algometry:

    Time frame: 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

  2. The Brief Pain Inventory (BPI):

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. The incremental shuttle walking test (ISWT):

    Time frame: 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

  2. Patient health questionnaire PHQ-9:

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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