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

NCT06098443 | Completed FDA Device

• 1 other identifier: P.T.REC/012/004482
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

• Patient health questionnaire PHQ-9:

  Patient health questionnaire PHQ-9:will be measured at baseline, and it will be measured again after eight weeks

Study Arms (2)

Acupressure

EXPERIMENTAL

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

Transcutaneous electrical nerve stimulation

ACTIVE COMPARATOR

• Placement electrodes applied on the painful area lower leg. Settings: * Intensity up to patient tolerance. * Duration 30min.

Device: Transcutaneous electrical nerve stimulation

Interventions

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.

Acupressure

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).

Transcutaneous electrical nerve stimulation

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11432, Egypt

Location

MeSH Terms

Interventions

Acupressure; Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia

Study Officials

• Hany Obaya, assistant professor

  giza, Egypt, 12511

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of physical therapy

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: November 28, 2023
• Primary Completion: January 30, 2024
• Study Completion: April 22, 2024
• Last Updated: May 13, 2024

Record last verified: 2023-12

Locations

EG (1)