Prospective randomized controlled clinical study of acupuncture in the treatment of restless legs syndrome after hemodialysis

Phase 1

• Conditions: Restless leg syndrome

• Registration Number: ITMCTR2100005178
• Lead Sponsor: Beijing Friendship Hospital Affiliated to Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age between 18-75 years old, male or female;
2. Maintenance hemodialysis (regular dialysis, 3 times a week, at least 6 months);
3. Meet the diagnostic criteria of RLS, and the severity rating scale [IRLS] score >= 15;
4. Body mass index 18-40 kg/m2, hemoglobin >=9g/dL (>=4.97 mmol/L), and ferritin concentration >=100 ng/m when enrolled.
5. Voluntarily participate and sign the informed consent.

Exclusion Criteria

1. Received acupuncture treatment in the past 2 weeks;
2. Patients with clinically relevant heart and cerebrovascular diseases and blood system diseases who cannot tolerate acupuncture treatment;
3. Taking drugs that may affect RLS (such as dopaminergic receptor agonists/antagonists, tricyclic antidepressants, lithium salts);
4. Clinically relevant polyneuropathy or venous and arterial related diseases cause abnormal sensation in the lower extremities;
5. Acute complications within 1 month, including acute infection, acute cardiovascular and cerebrovascular disease, active hepatitis, and connective tissue disease;
6. Cancer radiotherapy and chemotherapy within 1 year;
7. Pregnant or lactating women;
8. Drug or alcohol abuse within 1 year;
9. Patients with a history of severe nervous system and mental illness.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International RLS research group restless leg severity rating scale;

Secondary Outcome Measures

Name	Time	Method
suggested immobilization test;Hospital depression and anxiety scale;Pittsburgh sleep quality index;Restless leg quality of life questionnaire;