Clinical trial NCT06098443: Acupressure Versus Transcutaneous Electrical Nerve Stimulation on Pain and Quality of Life Intradialysis
Official title: Acupressure Versus Transcutaneous Electrical Nerve Stimulation on Pain and Quality of Life Intradialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain pressure algometry:
timeFrame: Pain pressure algometry:will be measured at baseline, and it will be measured again after eight weeks
measure: The Brief Pain Inventory (BPI):
timeFrame: The Brief Pain Inventory (BPI): will be measured at baseline, and it will be measured again after eight weeks
measure: Short form -36 questionnaire (KDQoL SF-36):
timeFrame: Short form -36 questionnaire (KDQoL SF-36):will be measured at baseline, and it will be measured again after eight weeks
Secondary outcomes:
measure: The incremental shuttle walking test (ISWT):
timeFrame: The incremental shuttle walking test (ISWT):will be measured at baseline, and it will be measured again after eight weeks
measure: Patient health questionnaire PHQ-9:
timeFrame: Patient health questionnaire PHQ-9:will be measured at baseline, and it will be measured again after eight weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: giza, Egypt, 12511
name: Hany Obaya, assistant professor
role: PRINCIPAL_INVESTIGATOR
References: