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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
Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Neuropathy focused on measuring Moxibustion, Peripheral Neuropathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 16, 2021
    Last Updated
    May 19, 2021
    Sponsor
    Xiamen University
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    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

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    Efficacy of Moxibustion in Diabetes Peripheral Neuropathy

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