ACUpuncture in Diabetic Peripheral Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-02

Study Completion Date

2021-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy

NCT05863793

Diabetic Peripheral Neuropathy

UNKNOWN NA

Group Acupuncture Treatment Effects for Painful Diabetic Neuropathy (GATE-PDN)

NCT02104466

Diabetic Peripheral Neuropathy

COMPLETED NA

Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy

NCT06054087

Diabetic Peripheral Neuropathic Pain

NOT_YET_RECRUITING NA

Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy

NCT05521737

Electroacupuncture Acupuncture Diabetic Polyneuropathy +3 more

RECRUITING NA

Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy

NCT04739631

Chemotherapy-Induced Peripheral Neuropathy (CIPN)

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will investigate the effect of a series of acupuncture treatments on subdimensions of neuropathic symptoms, such as pain, tingling and numbness. Neurophysiological testing of the affected nerves are incorporated into the study as a possible morphological correlate of functional and clinical findings.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multicenter, open label, randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The statistician will be blinded to the study intervention.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

acupuncture plus routine care

12 session of semistandardized acupuncture together with pharmacological routine care

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks

routine care

Intervention Type DRUG

pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)

routine care alone

pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)

Group Type ACTIVE_COMPARATOR

routine care

Intervention Type DRUG

pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acupuncture

semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks

Intervention Type PROCEDURE

routine care

pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of diabetic peripheral neuropathy in diabetes mellitus Type 2
* Males and females aged \>18yrs \< 70yrs
* Minimum overall complaints of minimum 40mm on a visual analogue scale (VAS)
* Completed titration of pain medication against diabetic peripheral neuropathy
* Pathological nerve conduction velocity and amplitude of N. suralis ( \<42meter/second and or \< 6 mikroVolt)

Exclusion Criteria

* Very severe diabetic peripheral neuropathy with muscular weakness of proximal leg muscles
* Neuropathy due to other reasons such as borrelia infection, HIV, hereditary, alcohol toxic, or related to history of neurotoxic drugs.
* Severe peripheral artery disease Fontaine stage IV
* Ulcers or gangrenous lesions of the feet

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No