Efficacy of Moxibustion in Diabetes Peripheral Neuropathy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Neuropathies; Peripheral Neuropathy
• Intervention / Treatment: Device: Moxibustion

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yun Jin Kim, Ph.D; Phone Number: 603-87055098; Email: yjkim@xmu.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Moxibustion; Moxibustion treatment sessions eight weeks from the baseline.	Device: Moxibustion; The moxibustion treatment sessions are three times per week for eight weeks. Indirect moxa stick will be used.; Other Names: Moxa stick
NO_INTERVENTION: Waiting; A waiting period of eight weeks by moxibustion treatment sessions in the same way with moxibustion group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment measured with Algometry	For determining sensitivity to pain produced by pressure	Measured from Baseline pain at 8 weeks
Pain assessment measured with the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale	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	Measured from Baseline pain at 8 weeks
Pain assessment measured with the Visual Analog Scale	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.	Measured from Baseline pain at 8 weeks
Pain assessment measured with the Neuropathy Pain Scale (NPS)	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.	Measured from Baseline pain at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of functional performance capacity with 6 minutes walking test	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.	Measured from Baseline results at 8 weeks
Evaluation of the Foot and Ankle Ability Measure (FAAM).	It is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments.	Measured from Baseline results at 8 weeks
Serum HbA1c	It is provides accurate long-term index of average blood glucose level	Measured from Baseline results at 8 weeks
Serum Albumin levels	It is measures the amount of the protein albumin in human blood	Measured from Baseline results at 8 weeks

Collaborators and Investigators

• Sponsor: Xiamen University
• Investigators: Study Chair: Linchao Qian, BMed, Xiamen University Malaysia; Study Director: Muhammad Shahzad Aslam, Ph.D, Xiamen University Malaysia

Publications and helpful links

General Publications

• Tay JS, Kim YJ. Efficacy of moxibustion in diabetes peripheral neuropathy. Medicine (Baltimore). 2021 Dec 10;100(49):e28173. doi: 10.1097/MD.0000000000028173.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: May 16, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (ACTUAL): May 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Peripheral Neuropathy; Moxibustion
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: XiamenU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No