Stellate Ganglion Stimulation for Restless Leg Syndrome in Hemodialysis Patients

NCT07657013 | Completed DMC

• 1 other identifier: SGB-RLS-2026
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial investigated the effect of transcutaneous stellate ganglion electrical nerve stimulation (TENS-SG) on restless legs syndrome (RLS) in patients undergoing hemodialysis. Thirty-six patients aged 40-50 years were randomly assigned to two equal groups: Group A received active TENS-SG applied over the cervical-thoracic (stellate ganglion) region three times weekly for four weeks, while Group B received placebo stimulation. The study evaluated multiple outcomes including RLS severity (IRLS scale), sleep quality (PSQI), quality of life (SF-12), pain perception (pressure pain threshold), blood pressure, psychological status (HADS), and plasma β-endorphin levels. Results demonstrated that TENS-SG significantly reduced RLS severity and improved sleep quality, pain threshold, quality of life, and psychological well-being compared to placebo. It also significantly reduced systolic and diastolic blood pressure and markedly increased β-endorphin levels. Overall, the findings suggest that TENS-SG is a safe, non-invasive, and effective intervention for improving neurological, cardiovascular, psychological, and quality-of-life outcomes in hemodialysis patients with RLS.

Conditions

Restless Leg Syndrome (RLS); Hemodialysis

Outcome Measures

Primary Outcomes (1)

• International Restless Leg Syndrome Rating Scale (IRLS)

  Assessment of restless legs syndrome severity using the International Restless Legs Syndrome Rating Scale. The scale consists of 10 items with a total score ranging from 0 to 40, where higher scores indicates greater symptoms severity (worse outcome).

  Baseline and 4 weeks after treatment

Secondary Outcomes (4)

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline and 4 weeks after treatment

• Short Form-12 Health Survey (SF-12)

  Baseline and 4 weeks after treatment

• Pressure Pain Threshold

  Baseline and 4 weeks after treatment

• Plasma Beta-Endorphin Level

  Baseline and 4 weeks after treatment

Study Arms (2)

TENS Group

EXPERIMENTAL

Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care

Device: transcutaneous electrical nerve stimulation (TENS)

Sham Stimulation Control Group

PLACEBO COMPARATOR

Patients will receive a placebo (sham) TENS intervention with electrodes applied but no electrical stimulation (zero intensity), in addition to standard care

Device: Sham transcutaneous electrical nerve stimulation

Interventions

transcutaneous electrical nerve stimulation (TENS) DEVICE

Transcutaneous electrical nerve stimulation is applied over the stellate ganglion region three times per week for four weeks. The stimulation is used as a non-invasive neuromodulation technique to manage restless legs syndrome in hemodialysis patients.

TENS Group

Sham transcutaneous electrical nerve stimulation DEVICE

Electrodes are applied over the same anatomical site as the active intervention; however, no electrical current is delivered (zero intensity). The procedure mimics the active treatment to ensure blinding of participants.

Sham Stimulation Control Group

Eligibility Criteria

• Age: 40 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients will be involved in this study according to the following criteria
• Patient undergoes four main clinical criteria for the diagnosis of RLS according to the international restless leg syndrome study group (IRLSSG) including
• an urge to move legs that is usually associated with paresthesia.
• alleviation of the symptoms by moving the legs.
• aggravation or exacerbation of the symptoms particularly at rest or during sitting or lying down in the bed.
• worsening of the signs at night.
• Male and Female patients.
• The age will range from 40-50 years old.
• BMI (Body Mass Index 25-34.9 kg/m2
• Patients with grade 2 Hypertension (160-179/100-109 mmHg)
• Hemodialysis patients for at least 1year and have restless leg syndrome (RLS).

You may not qualify if:

• History of Deep venous thrombosis
• History of Bleeding disorders
• Have an implantable device like a pacemaker
• Recent Infected wound
• History of allergic response to the electrodes, gel or tape
• patients who participating in any other exercise program
• Loss of sensation or numbness

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Marwa Mahmoud El Sayed, Assistant Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physiotherapist at El Kasr El Ainy Hospitals

Model Details: This study is a randomized controlled trial with parallel assignment. Participants will be randomly allocated using a computer-generated randomization sequence (Excel) into two equal groups. Group A will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care. Group B will receive a placebo (sham) TENS intervention with electrodes applied but no electrical stimulation (zero intensity), in addition to standard care.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: October 10, 2025
• Primary Completion: March 10, 2026
• Study Completion: May 30, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

EG (1)