Efficacy of Moxibustion in Diabetes Peripheral Neuropathy
Primary Purpose
Peripheral Neuropathy, Diabetic Neuropathies
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Moxibustion
Sponsored by
About this trial
This is an interventional prevention trial for Peripheral Neuropathy focused on measuring Moxibustion, Peripheral Neuropathy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Moxibustion
Waiting
Arm Description
Moxibustion treatment sessions eight weeks from the baseline.
A waiting period of eight weeks by moxibustion treatment sessions in the same way with moxibustion group.
Outcomes
Primary Outcome Measures
Pain assessment measured with Algometry
For determining sensitivity to pain produced by pressure
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
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.
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.
Secondary Outcome Measures
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.
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.
Serum HbA1c
It is provides accurate long-term index of average blood glucose level
Serum Albumin levels
It is measures the amount of the protein albumin in human blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04894461
Brief Title
Efficacy of Moxibustion in Diabetes Peripheral Neuropathy
Official Title
Efficacy of Moxibustion in Diabetes Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xiamen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Diabetic Neuropathies
Keywords
Moxibustion, Peripheral Neuropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moxibustion
Arm Type
Experimental
Arm Description
Moxibustion treatment sessions eight weeks from the baseline.
Arm Title
Waiting
Arm Type
No Intervention
Arm Description
A waiting period of eight weeks by moxibustion treatment sessions in the same way with moxibustion group.
Intervention Type
Device
Intervention Name(s)
Moxibustion
Other Intervention Name(s)
Moxa stick
Intervention Description
The moxibustion treatment sessions are three times per week for eight weeks. Indirect moxa stick will be used.
Primary Outcome Measure Information:
Title
Pain assessment measured with Algometry
Description
For determining sensitivity to pain produced by pressure
Time Frame
Measured from Baseline pain at 8 weeks
Title
Pain assessment measured with the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
Description
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
Time Frame
Measured from Baseline pain at 8 weeks
Title
Pain assessment measured with the Visual Analog Scale
Description
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.
Time Frame
Measured from Baseline pain at 8 weeks
Title
Pain assessment measured with the Neuropathy Pain Scale (NPS)
Description
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.
Time Frame
Measured from Baseline pain at 8 weeks
Secondary Outcome Measure Information:
Title
Evaluation of functional performance capacity with 6 minutes walking test
Description
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.
Time Frame
Measured from Baseline results at 8 weeks
Title
Evaluation of the Foot and Ankle Ability Measure (FAAM).
Description
It is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments.
Time Frame
Measured from Baseline results at 8 weeks
Title
Serum HbA1c
Description
It is provides accurate long-term index of average blood glucose level
Time Frame
Measured from Baseline results at 8 weeks
Title
Serum Albumin levels
Description
It is measures the amount of the protein albumin in human blood
Time Frame
Measured from Baseline results at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Jin Kim, Ph.D
Phone
603-87055098
Email
yjkim@xmu.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linchao Qian, BMed
Organizational Affiliation
Xiamen University Malaysia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Muhammad Shahzad Aslam, Ph.D
Organizational Affiliation
Xiamen University Malaysia
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
34889293
Citation
Tay JS, Kim YJ. Efficacy of moxibustion in diabetes peripheral neuropathy. Medicine (Baltimore). 2021 Dec 10;100(49):e28173. doi: 10.1097/MD.0000000000028173.
Results Reference
derived
Learn more about this trial
Efficacy of Moxibustion in Diabetes Peripheral Neuropathy
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