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Acupuncture and laser acupuncture treatment for diabetic peripheral neuropathy. A double-blind placebo controlled design in acupuncture research.

Acupuncture and laser acupuncture treatment for diabetic peripheral neuropathy. A double-blind placebo controlled design in acupuncture research. - ACUDIN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00008562
Enrollment
180
Registered
2015-06-29
Start date
2011-08-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

G63.2

Interventions

Group 1: Classical needle acupuncture (verum), 10 treatment sessions of 20 minutes, once weekly for 10 weeks Group 2: Verum Laser acupuncture (Laser on), 10 treatment sessions of 20 minutes, once week

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with diabetes mellitus type 2 and stable levels of HbA1c (deviation < 1% during the last 6 months), clinically assured diabetic peripheral neuropathy and pathologic results in nerve conduction studies of tibial nerve and sural nerve will be included.

Exclusion criteria

Exclusion criteria: Other diseases than diabetes that may cause peripheral neuropathy; History of epilepsy; Coagulopathy or use of anticoagulants with bleeding time > 3 min, prothrombin time 50 sec; Bacterial infection or other skin diseases at the lower extremities; Bone fracture of the lower extremities during the last three months; Alcohol, opiat, analgetic, or drug abuse; Psychiatric illnesses other than mild depression; Incapacity of following the study instructions ;(severe language disturbances, serious cognitive deficits, lack of time); Pregnant or breast-feeding women; Current participation in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Pre-post comparison of the sensory sural nerve action potential amplitude (SNAP) before and 4 weeks after the treatment (week 0 and 14) by nerve conduction studies

Secondary

MeasureTime frame
Pre-post comparison of sensory sural nerve conduction velocity, motor tibial nerve action potential amplitude and motor tibial nerve conduction velocity by nerve conduction studies; pre-post comparison of Neuropathic Deficit Score (NDS) and Neuropathic Symptom Score (NSS) as well as of subjective complaints by visual analogue scales (VAS) before and 4 weeks after the treatment (week 0 and week 14)

Countries

Germany

Contacts

Public ContactSven Schroeder

HanseMerkur Zentrum für Traditionelle Chinesische Medizin am Universitätsklinikum Hamburg-Eppendorf

praxis@tcm-m-uke.de+49 40 413 57 990

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 7, 2026