Efficacy of Moxibustion in Diabetes Peripheral Neuropathy

Xiamen University

Status: Unknown

Conditions: Peripheral Neuropathy; Diabetic Neuropathies

Treatments: Device: Moxibustion

Study type: Interventional

Funder types: Other

Identifiers

NCT04894461

XiamenU

Details and patient eligibility

About

This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on diabetes peripheral neuropathy.

Full description

Background: The purpose of this study is to investigate the clinical effects of moxibustion for treating diabetes peripheral neuropathy.

Hypothesis: Subjects who have participated in the moxibustion treatment will have greater improvement in people with diabetes with signs and symptoms of peripheral neuropathy than the control group after 8 weeks.

Design and subjects: A pilot randomized controlled trial. Subjects with diabetes peripheral neuropathy will be recruited from the community. 30 subjects will be randomized to moxibustion groups and control groups in a 1:1 ratio.

Interventions: Subjects in the moxibustion group will receive three times per week for 12 weeks; control groups will be allocated to the waitlist will receive no moxibustion treatments throughout the 8 weeks.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients between 18 and 75 years with diagnosed diabetes mellitus, according to WHO criteria.
• Proven peripheral neuropathy.
• Written consent with documentation that all participants received relevant information about this study is given to the patient.
• The participants must be willing and able to meet the planned visit and meet the planned schedule, including participation in the experimental investigations.

Exclusion criteria

• Health professionals' assessment makes the patient have medical or surgical diseases unsuitable to participate in the study.
• Pregnancy or breastfeeding for female patients.
• Competitive conditions that can cause peripheral neuropathy.
• Participants involved in the planning or execution of the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Moxibustion

Experimental group

Description:

Moxibustion treatment sessions eight weeks from the baseline.

Treatment:

Device: Moxibustion

Waiting

No Intervention group

Description:

A waiting period of eight weeks by moxibustion treatment sessions in the same way with moxibustion group.