Efficacy of Moxibustion in Diabetes Peripheral Neuropathy

Peripheral Neuropathy Clinical Trial

Official title:

Efficacy of Moxibustion in Diabetes Peripheral Neuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04894461
• Other study ID #: XiamenU
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2021
• Source: Xiamen University
• Contact: Yun Jin Kim, Ph.D
• Phone: 603-87055098
• Email: yjkim[@]xmu.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment measured with Algometry	For determining sensitivity to pain produced by pressure	Measured from Baseline pain at 8 weeks
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Serum HbA1c	It is provides accurate long-term index of average blood glucose level	Measured from Baseline results at 8 weeks
Secondary	Serum Albumin levels	It is measures the amount of the protein albumin in human blood	Measured from Baseline results at 8 weeks