The Effect of Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis (RLS/CKD-aP)

"Effect of Combined Traditional and Paraspinal Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of combined traditional and paraspinal acupressure on restless legs syndrome and pruritus among patients undergoing hemodialysis. Participants will be randomly assigned to either an intervention group receiving the acupressure intervention in addition to routine hemodialysis care or a control group receiving routine care only. The severity of restless legs syndrome and pruritus will be assessed at predetermined time points using validated assessment tools. The study aims to determine whether the combined acupressure intervention is effective in reducing restless legs syndrome and pruritus symptoms in patients undergoing hemodialysis

Study Overview

• Status: Not yet recruiting
• Conditions: Restless Leg Syndrome (RLS)
• Intervention / Treatment: Other: Vibration Assisted Acupressure

Detailed Description

Participants allocated to the intervention group will receive combined traditional and paraspinal acupressure in addition to routine hemodialysis care. The intervention will involve stimulation of selected acupressure points using a vibration acupressure device.

The paraspinal component will include selected thoracic and lumbar points (BL13, BL17, BL23, BL24, and BL25) and will be applied before the hemodialysis session. Traditional peripheral acupressure points, including SP6, SP10, ST36, LI11, LR3, and BL57, will be stimulated during the hemodialysis session.The intervention will be administered according to a standardized protocol regarding point localization, application technique, duration, and frequency to ensure consistency among participants. Participants will be observed during the intervention for any discomfort or adverse events.

Participants allocated to the control group will continue to receive routine hemodialysis care without the acupressure intervention during the study period.

Restless legs syndrome severity and pruritus severity will be evaluated using validated instruments at three predetermined assessment time points. The collected data will be used to examine changes in symptoms over time and differences between the two study groups.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa Kadhim Abdul-Hameed, Assist lecturer; Phone Number: +9647763497862; Email: alaa-kadhim@utq.edu.iq

Study Locations

• Iraq
  • Dhi Qar
    • Dhi-Qar, Dhi Qar, Iraq, 64001
      • Al-Hussien Hemodialysis center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria

1. Patients more than 18 years old on hemodialysis treatment for more than 2 sessions per week.
2. The patients on hemodialysis for more than 3 months
3. The patients who complain of restless leg syndrome and pruritus.
4. RLS diagnosis meeting the diagnostic criteria defined by the International Restless Legs Syndrome Study Group (IRLSSG).
5. At least moderate RLS symptoms (IRLS - total score ≥ 11)
6. Patients who score more than five on the 5D Pruritus scale.
7. Patient with a history of pruritus for more than 3 months.

Exclusion Criteria

1. Patients with impaired skin integrity.
2. Patients with skin lesions in areas involved in acupressure therapy.
3. Patients with neurological deficits as perception of pain, may differ from other patients.
4. Patients with a body mass index (BMI) of more than > 30 kg/m².
5. Patients with malignancy.
6. Patients with Jaundice.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group (Vibration assisted acupressure); Participants in this group will receive vibration-assisted acupressure using an acupressure device applied to selected acupoints in addition to routine hemodialysis care. The intervention will be administered according to the study protocol to evaluate its effects on restless legs syndrome and pruritus among patients undergoing	Other: Vibration Assisted Acupressure; Vibration-assisted acupressure will be applied to selected traditional and paraspinal acupoints using a handheld vibration device. The intervention is designed to reduce the severity of restless legs syndrome and pruritus in patients undergoing hemodialysis. It will be administered according to a predefined intervention protocol in addition to routine hemodialysis care
No Intervention: CONTROL GROUP; Participants will receive routine hemodialysis care without the acupressure intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Restless Legs Syndrome Severity Assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS)	The questionnaire consisted of 10 items, each of which had a scale ranging from 0 (no impact) to 4 (very severe impact). RLS severity was defined as mild (0-10 points), moderate (11-20 points), severe (21-30 points), or very severe (31-40 points).	Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
Change in Pruritus Severity Assessed by the 5-D Itch Scale	Pruritus severity will be assessed using the 5-D Itch Scale, which evaluates five dimensions of itching: duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating greater severity and impact of pruritus	Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Study Director: Hakima Shaker Hassan, Assist prof, College of Nursing/ University of Baghdad

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 5, 2026
• First Submitted That Met QC Criteria: September 5, 2026
• First Posted (Actual): September 11, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 5, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Restless Legs Syndrome
• Other Study ID Numbers: 133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No