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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxibustion | Experimental | Moxibustion treatment sessions eight weeks from the baseline. |
|
| Waiting | No Intervention | A waiting period of eight weeks by moxibustion treatment sessions in the same way with moxibustion group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxibustion | Device | The moxibustion treatment sessions are three times per week for eight weeks. Indirect moxa stick will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured from Baseline results at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Jin Kim, Ph.D | Contact | 603-87055098 | yjkim@xmu.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Linchao Qian, BMed | Xiamen University Malaysia | Study Chair |
| Muhammad Shahzad Aslam, Ph.D | Xiamen University Malaysia | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34889293 | Derived | Tay JS, Kim YJ. Efficacy of moxibustion in diabetes peripheral neuropathy. Medicine (Baltimore). 2021 Dec 10;100(49):e28173. doi: 10.1097/MD.0000000000028173. |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D009071 | Moxibustion |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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. |
| Measured from Baseline results at 8 weeks |
| Serum HbA1c | It is provides accurate long-term index of average blood glucose level | Measured from Baseline results at 8 weeks |
| Serum Albumin levels | It is measures the amount of the protein albumin in human blood | Measured from Baseline results at 8 weeks |
| D004700 | Endocrine System Diseases |