Clinical trial NCT04894461: Efficacy of Moxibustion in Diabetes Peripheral Neuropathy
Official title: Efficacy of Moxibustion in Diabetes Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Neuropathy
Diabetic Neuropathies
Keywords: Moxibustion
Peripheral Neuropathy
Lead sponsor: Xiamen University
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Pain assessment measured with Algometry
timeFrame: Measured from Baseline pain at 8 weeks
measure: Pain assessment measured with the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
timeFrame: Measured from Baseline pain at 8 weeks
measure: Pain assessment measured with the Visual Analog Scale
timeFrame: Measured from Baseline pain at 8 weeks
measure: Pain assessment measured with the Neuropathy Pain Scale (NPS)
timeFrame: Measured from Baseline pain at 8 weeks
Secondary outcomes:
measure: Evaluation of functional performance capacity with 6 minutes walking test
timeFrame: Measured from Baseline results at 8 weeks
measure: Evaluation of the Foot and Ankle Ability Measure (FAAM).
timeFrame: Measured from Baseline results at 8 weeks
measure: Serum HbA1c
timeFrame: Measured from Baseline results at 8 weeks
measure: Serum Albumin levels
timeFrame: Measured from Baseline results at 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Xiamen University Malaysia
name: Linchao Qian, BMed
role: STUDY_CHAIR
affiliation: Xiamen University Malaysia
name: Muhammad Shahzad Aslam, Ph.D
role: STUDY_DIRECTOR
References:
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.