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Clinical observation for chemical neurolysis of lumbar sympathetic nerve block in the treatment of patients with restless legs syndrome: a prospective randomized controlled clinical trial

Clinical observation for chemical neurolysis of lumbar sympathetic nerve block in the treatment of patients with restless legs syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076987
Enrollment
Unknown
Registered
2023-10-26
Start date
2023-10-31
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Restless legs syndrome,RLS

Interventions

experimental group:chemical neurolysis of lumbar sympathetic nerve block (absolute alcohol injection/chemical neurolysis)

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Understand and voluntarily endorse informed consent; 2. Male or female and 18 years of age or older; 3. Patients who are diagnosed as RLS for the first time according to the International Restless Legs Syndrome Study Group diagnostic criteria for idiopathic RLS and have not used any drugs to treat RLS. 4. Patients who have an International Restless Legs Rating Scale (IRLS) score at baseline greater than 10 5. Patients who have suffered symptoms at least 3 times per week. 6. Patients who can be able to follow the drug dose and the follow-up plan; 7. Patients who can objectively describe the symptoms, can take the initiative to cooperate, without any mental illness.

Exclusion criteria

Exclusion criteria: Subjects complying with any of the following exclusion criteria are not eligible to participate in this study: 1. Patients who have any objections to this trial; 2. Serious organ damage, such as CHF (congestive heart-failure), patients with clinical symptoms of coronary artery disease and arrhythmia uncontrollable by existing medicines, etc.; 3. MRI examination showed that patients were not suitable for sympathetic nerve block 4.Patients with allergic diseases, allergic constitution, drug allergic history (gabapentin, pregabalin, oxycodone-acetaminophen, local anesthetics, absolute alcohol;); 5.Severe systemic infection, Coagulation dysfunction; 6.Patients with psychiatric disease affecting assessments; 7.Patients with malignant tumor or with a history of malignant tumor. 8. Patients unable to follow the follow-up plan; 9. Patients in other clinical research at the same time; 10. The patients that researchers do not consider fit for the trial

Design outcomes

Primary

MeasureTime frame
IRLS;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index,PSQI;Athens Insomnia Scale,AIS;Visual Analogue Scale / Score,VAS;Clinical Global Impressions-S (CGI) scale;Drug consumption;

Countries

China

Contacts

Public ContactDaosong Dong

The First Affiliated Hospital of China Medical University

dds_19861118@163.com+86 135 9166 0261

Outcome results

None listed

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