This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on diabetes peripheral neuropathy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
40
The moxibustion treatment sessions are three times per week for eight weeks. Indirect moxa stick will be used.
Pain assessment measured with Algometry
For determining sensitivity to pain produced by pressure
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Measured from Baseline pain at 8 weeks
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.
Time frame: Measured from Baseline results at 8 weeks
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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.
Time frame: Measured from Baseline results at 8 weeks
Serum HbA1c
It is provides accurate long-term index of average blood glucose level
Time frame: Measured from Baseline results at 8 weeks
Serum Albumin levels
It is measures the amount of the protein albumin in human blood
Time frame: Measured from Baseline results at 8 weeks