Restless Legs Syndrome
Conditions
Interventions
treatment group:acupuncture
control group:Sham acupuncture
Sponsors
Yueyang Integrative Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged 18–75 years. 2. All patients with primary RLS meet the 2014 International RLS Research Group diagnostic criteria21; 3. Nervous system physical examination is normal; 4. Participants who have not received acupuncture treatment before. 5. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Secondary RLS caused by iron deficiency anemia, rheumatoid arthritis, Parkinson's disease, peripheral neuropathy and other diseases; 2. Participants who are suffering from other organic diseases, such as cardiovascular, liver, kidney, lung and other serious primary diseases; or accompanied by severe mental symptoms; 3. Pregnant and lactating women 4. Participants who took drugs that affect sleep and periodic limb movement index changes (such as tricyclic antidepressants, sleeping pills, dopamine drugs, etc.) within 2 weeks before the examination; 5. Participants who refuse acupuncture and MRI and PET-CT; 6. Participants who have participated in other clinical studies 3 months before enrollment or are participating in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Restless Legs severity rating scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| RLS-Quality of Life;Pittsburgh Sleep Quality Index; Insomnia Severity Index;Epworth Sleepines s Scale;Hamilton Depression Sale;Hamilton Ansiety Sale;Polysomnogram;The head PET - CT;The head MRI; | — |
Countries
China
Contacts
Public ContactWenjia Yang
Yueyang Integrative Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed