Efficacy of Moxibustion in Diabetes 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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-12-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Peripheral Neuropathy Diabetic Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Moxibustion

Moxibustion treatment sessions eight weeks from the baseline.

Group Type EXPERIMENTAL

Moxibustion

Intervention Type DEVICE

The moxibustion treatment sessions are three times per week for eight weeks. Indirect moxa stick will be used.

Waiting

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Moxibustion

The moxibustion treatment sessions are three times per week for eight weeks. Indirect moxa stick will be used.

Intervention Type DEVICE

Other Intervention Names

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Moxa stick

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No