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A Randomized controlled study on Acupuncture treatment of RLS patients after Hemodialysis based on the Theory of "Tiaoxue Anshen"

A Randomized controlled study on Acupuncture treatment of RLS patients after Hemodialysis based on the Theory of "Tiaoxue Anshen"

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083667
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-05-31
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Leg Syndrome

Interventions

Acupuncture group:Make the patient in the supine position or sitting position, after routine disinfection of acupoints, choose disposable needle pad to put on acupoints, and then use sterile acupunctu
Sham Acupuncture group:Make the patient in the supine position or sitting position, after routine disinfection of acupoints, choose a disposable needle pad to be placed on the false acupoint, and then

Sponsors

Dongzhimen Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of restless leg syndrome; (2) The age is between 18 and 65 years old. (3) Had a history of chronic renal failure and received regular continuous hemodialysis for at least 3 months; (4) Regular dialysis at least 3 times a week; (5) Currently did not take drugs to treat RLS, such as dopamine agonists, benzodiazepines, opioids and gabapentin; (6) No history of other motor disorders, such as Parkinson's disease, dyskinesia and dystonia. (7) The subjects signed the informed consent form and were willing to participate in this experiment.

Exclusion criteria

Exclusion criteria: (1) Suffering from other organic diseases, or accompanied by severe mental symptoms; (2) Women who are pregnant, breastfeeding and preparing for pregnancy; (3) Sleep disorders caused by other causes; (4) Those with acupuncture contraindications, such as blood diseases, local infection, etc.; (5) Are using other treatments or are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Periodic Limb Movement Index, PLMI;Blind Evaluation Form;

Secondary

MeasureTime frame
International Restless Leg Scale, IRLS;Pittsburgh Sleep Quality Index, PSQI;Restless Legs Syndrome Quality of Life Questionnaire, RLSQoL;Clinical Global Impression, CGI;Visual Analogue Scale, VAS;Self-Rating Anxiety Scale, SAS;Self-Rating Depression Scale, SDS;Acupuncture Expectancy Scale, AES;Massachusetts General Hospital Acupuncture Sensation Scale (Chinese Version) , C-MASS;

Countries

China

Contacts

Public ContactJun Wang

Dongzhimen Hospital Beijing University of Chinese Medicine

wangjunee@bucm.edu.cn+86 158 1148 0301

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026