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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005178
Enrollment
Unknown
Registered
2021-08-16
Start date
2021-09-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Restless leg syndrome

Interventions

Sponsors

Beijing Friendship Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Secondary

MeasureTime frame
suggested immobilization test;Hospital depression and anxiety scale;Pittsburgh sleep quality index;Restless leg quality of life questionnaire;

Primary

MeasureTime frame
International RLS research group restless leg severity rating scale;

Countries

China

Contacts

Public ContactLi Juanjuan

Beijing Friendship Hospital Affiliated to Capital Medical University

845978483@qq.com+86 15501096083

Outcome results

None listed

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