Peripheral NeuropathyNCT04894461
Efficacy of Moxibustion in Diabetes Peripheral Neuropathy
A study testing Moxibustion in people with Peripheral Neuropathy and Diabetic Neuropathies, run by Xiamen University.
Trial summary
This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on diabetes peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Neuropathy, Diabetic Neuropathies
- What is being tested?
- Moxibustion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on diabetes peripheral neuropathy.
Read the 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.
- Conditions
- Peripheral Neuropathy, Diabetic Neuropathies
- Being tested
- Moxibustion
- Keywords
- Moxibustion, Peripheral Neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxibustionDevice
Also called Moxa stick
The moxibustion treatment sessions are three times per week for eight weeks. Indirect moxa stick will be used.
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion | Experimental | Moxibustion treatment sessions eight weeks from the baseline. Receives: Device: Moxibustion |
| Waiting | No intervention | A waiting period of eight weeks by moxibustion treatment sessions in the same way with moxibustion group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment measured with Algometry
For determining sensitivity to pain produced by pressure
Measured: 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: 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: 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: Measured from Baseline pain at 8 weeks
Secondary outcomes (4)
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: Measured from Baseline results at 8 weeks
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: Measured from Baseline results at 8 weeks
Serum HbA1c
It is provides accurate long-term index of average blood glucose level
Measured: Measured from Baseline results at 8 weeks
Serum Albumin levels
It is measures the amount of the protein albumin in human blood
Measured: Measured from Baseline results at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Nov 2021 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Yun Jin, Xiamen University Malaysia
- Investigators
- Linchao Qian, BMed, Study chair, Xiamen University MalaysiaMuhammad Shahzad Aslam, Ph.D, Study director, Xiamen University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894461
- Sponsor's protocol ID
- XiamenU
- Status last verified
- May 2021
- First submitted
- 16 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tay JS, Kim YJ. Efficacy of moxibustion in diabetes peripheral neuropathy. Medicine (Baltimore). 2021 Dec 10;100(49):e28173. doi: 10.1097/MD.0000000000028173.
PubMed 34889293
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Moxibustion in Diabetes Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04894461
- Acronym / sponsor ID
- XiamenU
- Conditions
- Peripheral Neuropathy, Diabetic Neuropathies
- Keywords
- Moxibustion, Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxibustion | Experimental | Device: MoxibustionMoxibustion 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoxibustionAlso: Moxa stickThe moxibustion treatment sessions are three times per week for eight weeks. Indirect moxa stick will be used. | Device | Moxibustion |
Primary outcome
Pain assessment measured with Algometry
Time frame: Measured from Baseline pain at 8 weeks
For determining sensitivity to pain produced by pressure
Pain assessment measured with the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
Time frame: Measured from Baseline pain at 8 weeks
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
Time frame: Measured from Baseline pain at 8 weeks
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)
Time frame: Measured from Baseline pain at 8 weeks
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.
4 secondary outcomes
Evaluation of functional performance capacity with 6 minutes walking test
Time frame: Measured from Baseline results at 8 weeks
Evaluation of the Foot and Ankle Ability Measure (FAAM).
Time frame: Measured from Baseline results at 8 weeks
Serum HbA1c
Time frame: Measured from Baseline results at 8 weeks
Serum Albumin levels
Time frame: Measured from Baseline results at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Derived from this study: PubMed 34889293Tay 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linchao Qian, BMed study chair
Xiamen University Malaysia
Muhammad Shahzad Aslam, Ph.D study director
Xiamen University Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing Moxibustion in people with Peripheral Neuropathy and Diabetic Neuropathies, run by Xiamen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Jin Kim, Ph.D (603-87055098, yjkim@xmu.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment measured with Algometry (time frame: Measured from Baseline pain at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.