Efficacy of Moxibustion in Diabetes Peripheral Neuropathy

NCT04894461 | Unknown

• 1 other identifier: XiamenU
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Peripheral Neuropathy; Diabetic Neuropathies

Keywords

Moxibustion; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Evaluation of functional performance capacity with 6 minutes walking test

  Measured from Baseline results at 8 weeks

• Evaluation of the Foot and Ankle Ability Measure (FAAM).

  Measured from Baseline results at 8 weeks

• Serum HbA1c

  Measured from Baseline results at 8 weeks

• Serum Albumin levels

  Measured from Baseline results at 8 weeks

Study Arms (2)

Moxibustion

EXPERIMENTAL

Moxibustion treatment sessions eight weeks from the baseline.

Device: Moxibustion

Waiting

NO INTERVENTION

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

Interventions

Moxibustion DEVICE

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

Also known as: Moxa stick

Moxibustion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiamen University: lead

Related Publications (1)

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

  PMID: 34889293 DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Diabetic Neuropathies

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Study Officials

• Linchao Qian, BMed

  Xiamen University Malaysia

  STUDY CHAIR

• Muhammad Shahzad Aslam, Ph.D

  Xiamen University Malaysia

  STUDY DIRECTOR

Central Study Contacts

Yun Jin Kim, Ph.D

CONTACT

603-87055098; yjkim@xmu.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2021
• First Posted: May 20, 2021
• Study Start: November 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 20, 2021

Record last verified: 2021-05