Restless Leg Syndrome (RLS)NCT07657013
Stellate Ganglion Stimulation for Restless Leg Syndrome in Hemodialysis Patients
A study testing transcutaneous electrical nerve stimulation (TENS) in people with Restless Leg Syndrome (RLS) and Hemodialysis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Restless Leg Syndrome (RLS), Hemodialysis
- What is being tested?
- transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 36 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.
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- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Stellate Ganglion Electrical Stimulation on Restless Leg Syndrome in Hemodialysis Patients
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.
Read more
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
- Being tested
- transcutaneous electrical nerve stimulation (TENS), Sham transcutaneous electrical nerve stimulation
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham transcutaneous electrical nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TENS Group | Experimental | Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care Receives: 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 Receives: Device: Sham transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 4 weeks after treatment
Secondary outcomes (4)
Pittsburgh Sleep Quality Index (PSQI)
Assessment of sleep quality using the Pittsburgh Sleep Quality Index. the total score ranges from 0 to 21, where higher scores indicate poorer sleep quality (worse outcome).
Measured: Baseline and 4 weeks after treatment
Short Form-12 Health Survey (SF-12)
Assessment of health-related quality of life using the SF-12 questionnaire. physical and mental component summary scores typically range from 0 to 100, where higher scores indicate better health related quality of life (better outcome).
Measured: Baseline and 4 weeks after treatment
Pressure Pain Threshold
Assessment of pressure pain threshold using pressure algometry
Measured: Baseline and 4 weeks after treatment
Plasma Beta-Endorphin Level
Measurement of plasma beta-endorphin concentration from blood samples
Measured: Baseline and 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start10 Oct 2025
- Primary completion10 Mar 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Leg Syndrome (RLS)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Mohamed Mohamed Mabrouk, Cairo University
- Investigators
- Marwa Mahmoud El Sayed, Assistant Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657013
- Sponsor's protocol ID
- SGB-RLS-2026
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Stellate Ganglion Electrical Stimulation on Restless Leg Syndrome in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07657013
- Acronym / sponsor ID
- SGB-RLS-2026
- Conditions
- Restless Leg Syndrome (RLS), Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TENS Group | Experimental | Device: transcutaneous electrical nerve stimulation (TENS)Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care |
| Sham Stimulation Control Group | Placebo comparator | Device: Sham transcutaneous electrical nerve stimulationPatients will receive a placebo (sham) TENS intervention with electrodes applied but no electrical stimulation (zero intensity), in addition to standard care |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 36 patients will be involved in this study according to the following criteria
Key exclusion criteria (7 listed)
- History of Deep venous thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical nerve stimulation (TENS)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. | Device | TENS Group |
| Sham transcutaneous electrical nerve stimulationElectrodes 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. | Device | Sham Stimulation Control Group |
Primary outcome
International Restless Leg Syndrome Rating Scale (IRLS)
Time frame: Baseline and 4 weeks after treatment
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).
4 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 4 weeks after treatment
Short Form-12 Health Survey (SF-12)
Time frame: Baseline and 4 weeks after treatment
Pressure Pain Threshold
Time frame: Baseline and 4 weeks after treatment
Plasma Beta-Endorphin Level
Time frame: Baseline and 4 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Mahmoud El Sayed, Assistant Professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical nerve stimulation (TENS) in people with Restless Leg Syndrome (RLS) and Hemodialysis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Restless Leg Syndrome Rating Scale (IRLS) (time frame: Baseline and 4 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.