Efficacy of Moxibustion in Diabetes Peripheral Neuropathy

Not Applicable

• Conditions: Peripheral Neuropathy; Diabetic Neuropathies
• Interventions: Device: Moxibustion

• Registration Number: NCT04894461
• Lead Sponsor: Xiamen University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-16
• Study First Submitted QC: 2021-05-19
• Last Update Submitted: 2021-05-19
• Study First Posted: 2021-05-20
• Last Update Posted: 2021-05-20
• Study Start: 2021-11-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxibustion	Moxibustion	Moxibustion treatment sessions eight weeks from the baseline.

Primary Outcome Measures

Name	Time	Method
Pain assessment measured with Algometry	Measured from Baseline pain at 8 weeks	For determining sensitivity to pain produced by pressure
Pain assessment measured with the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale	Measured from Baseline pain at 8 weeks	The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale is based on analysis of sensory description and bedside examination of sensory dysfunction, and provides immediate information in clinical settings. The possible scores range from 0 to 24, with a score of 12 or greater considered to be suggestive of neuropathic pain
Pain assessment measured with the Visual Analog Scale	Measured from Baseline pain at 8 weeks	A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Pain assessment measured with the Neuropathy Pain Scale (NPS)	Measured from Baseline pain at 8 weeks	Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 10 indicates the most pain imaginable. The NPS is only for use in patients who have already been diagnosed with neuropathic pain.

Secondary Outcome Measures

Name	Time	Method
Evaluation of functional performance capacity with 6 minutes walking test	Measured from Baseline results at 8 weeks	It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Evaluation of the Foot and Ankle Ability Measure (FAAM).	Measured from Baseline results at 8 weeks	It is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments.
Serum HbA1c	Measured from Baseline results at 8 weeks	It is provides accurate long-term index of average blood glucose level
Serum Albumin levels	Measured from Baseline results at 8 weeks	It is measures the amount of the protein albumin in human blood