Restless Leg Syndrome (RLS)RLS/CKD-aPNCT07814443
The Effect of Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis
A study testing Vibration Assisted Acupressure in people with Restless Leg Syndrome (RLS), run by University of Baghdad at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Leg Syndrome (RLS)
- What is being tested?
- Vibration Assisted Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients more than 18 years old on hemodialysis treatment for more than 2 sessions per week.
- The patients on hemodialysis for more than 3 months
- The patients who complain of restless leg syndrome and pruritus.
- RLS diagnosis meeting the diagnostic criteria defined by the International Restless Legs Syndrome Study Group (IRLSSG).
- At least moderate RLS symptoms (IRLS - total score ≥ 11)
- Patients who score more than five on the 5D Pruritus scale.
- Patient with a history of pruritus for more than 3 months.
Who cannot join
- Patients with impaired skin integrity.
- Patients with skin lesions in areas involved in acupressure therapy.
- Patients with neurological deficits as perception of pain, may differ from other patients.
- Patients with a body mass index (BMI) of more than > 30 kg/m².
- Patients with malignancy.
- Patients with Jaundice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: "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
Read the 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.
- Conditions
- Restless Leg Syndrome (RLS)
- Being tested
- Vibration Assisted Acupressure
- 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.
Vibration Assisted AcupressureOther
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
| Study group | Role | What they receive |
|---|---|---|
| intervention group (Vibration assisted acupressure) | Experimental | 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 Receives: Other: Vibration Assisted Acupressure |
| CONTROL GROUP | No intervention | Participants will receive routine hemodialysis care without the acupressure intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
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 University of BaghdadThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Kadhim Abdul-Hameed, University of Baghdad
- Investigators
- Hakima Shaker Hassan, Assist prof, Study director, College of Nursing/ University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814443
- Sponsor's protocol ID
- 133
- Acronym
- RLS/CKD-aP
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Combined Traditional and Paraspinal Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07814443
- Acronym / sponsor ID
- RLS/CKD-aP / 133
- Conditions
- Restless Leg Syndrome (RLS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 11 Sep 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 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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group (Vibration assisted acupressure) | Experimental | Other: Vibration Assisted AcupressureParticipants 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 |
| CONTROL GROUP | No intervention | –Participants will receive routine hemodialysis care without the acupressure intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients more than 18 years old on hemodialysis treatment for more than 2 sessions per week.
- The patients on hemodialysis for more than 3 months
- The patients who complain of restless leg syndrome and pruritus.
- RLS diagnosis meeting the diagnostic criteria defined by the International Restless Legs Syndrome Study Group (IRLSSG).
- At least moderate RLS symptoms (IRLS - total score ≥ 11)
Key exclusion criteria (6 listed)
- Patients with impaired skin integrity.
- Patients with skin lesions in areas involved in acupressure therapy.
- Patients with neurological deficits as perception of pain, may differ from other patients.
- Patients with a body mass index (BMI) of more than > 30 kg/m².
- Patients with malignancy.
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 |
|---|---|---|
| Vibration Assisted AcupressureVibration-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 | Other | intervention group (Vibration assisted acupressure) |
Primary outcome
Change in Restless Legs Syndrome Severity Assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS)
Time frame: Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
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).
Change in Pruritus Severity Assessed by the 5-D Itch Scale
Time frame: Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Hakima Shaker Hassan, Assist prof study director
College of Nursing/ University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration Assisted Acupressure in people with Restless Leg Syndrome (RLS), run by University of Baghdad at 1 site in Iraq.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 Sep 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 Iraq. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Kadhim Abdul-Hameed, Assist lecturer (+9647763497862, alaa-kadhim@utq.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Restless Legs Syndrome Severity Assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS) (time frame: Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention). The study lists 2 primary outcomes in all. 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 11 Sep 2026.