Evidence map›Paper›PMID 35042552›Full record

ArticleTrials2022

10.6-μm infrared laser as adjuvant therapy for diabetic peripheral neuropathy: study protocol for a double-blind, randomized controlled trial.

Lin Lin, Yi Chen, Yuxia Li, Ke Cheng, Haiping Deng, Jianping Lu, Ling Zhao, Xueyong Shen

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Lin Lin *School of Nursing, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.
Yi Chen *Shanghai Municipal Hospital of Traditional Chinese Medicine, 274 Zhijiang Middle Road, 200071, Shanghai, China.
Yuxia LiSchool of Nursing, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China. graceliyuxia@163.com.
Ke ChengSchool of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, 201203, Shanghai, China. cheng_ker@hotmail.com.
Haiping DengSchool of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, 201203, Shanghai, China.
Jianping LuShanghai Municipal Hospital of Traditional Chinese Medicine, 274 Zhijiang Middle Road, 200071, Shanghai, China.
Ling ZhaoSchool of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, 201203, Shanghai, China.
Xueyong ShenSchool of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, 201203, Shanghai, China. sxy1@shutcm.edu.cn.ORCID http://orcid.org/0000-0003-4177-8970
Shanghai University of Traditional Chinese Medicine · CNShanghai Traditional Chinese Medicine Hospital · CN

Funding

Budgetary scientific research program of Shanghai University of Traditional Chinese Medicine 2020WK140the Three-Year development plan project for Traditional Chinese Medicine of Shanghai Municipal Health Commission ZY (2018-2020)-CCCX-1006the Three-Year development plan project for Traditional Chinese Medicine of Shanghai Municipal Health Commission ZY (2018-2020)-CCCX-2001-05
6 · The paper itself

Abstract

backgroundDiabetic peripheral neuropathy (DPN) is the most common chronic neurological complication. It is the main cause of disability in diabetes mellitus (DM) patients and seriously affects the quality of life of patients. Pharmacological treatments always associate with limited efficacy and adverse effects. Moxibustion has been recommended to treat DPN as an adjuvant therapy to conventional medical treatment to accelerate alleviation of the symptoms of DPN. 10.6-μm laser moxibustion (LM), whose wavelength is close to the peak of infrared radiation spectrum of the traditional moxibustion as well as human acupoints, produces the thermal effect similar with moxibustion but with no smoke or smell. The purpose of this sham controlled clinical trial is to determine the effect and safety of 10.6-μm LM as adjuvant therapy in patients with DPN.

methodsThis is a protocol for a randomized, double-blind, sham-controlled trial. One hundred fourteen patients meeting the inclusion and exclusion criteria will be recruited and randomly assigned to the LM group or the sham LM group with a 1:1 allocation ratio. Patients in both groups will receive a basic integrated treatment of Chinese and Western medicine and a total of 12 sessions of true or sham LM treatments over 4 weeks with 3 sessions a week. The primary outcome is nerve conduction velocity (NCV), and the secondary outcomes include Michigan Neuropathy Screening Instrument (MNSI) scores, Diabetes-Specific Quality of Life (DSQL) scores, blood rheology parameters, and assessments of safety and blinding. Outcome measures will be collected at baseline, 2 weeks after treatment, the end of LM treatments (4 weeks), and 4, 8 weeks after the end of LM treatment (8, 12weeks). DISCUSSION: This study will be conducted to compare the efficacy of LM versus sham LM combined with medical treatment. 10.6-μm LM may alleviate symptoms, improve quality of life, and reduce the dosage of drugs as well as avoid causing serious side effects.

trial registrationChinese Clinical Trial Registry ChiCTR2000029329 . Registered on 25 January 2020.

Indexed as

Diabetes MellitusDiabetic NeuropathiesMoxibustionDouble-Blind MethodHumansLasersQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeDiabetic peripheral neuropathyLaser moxibustionNerve conduction velocityTraditional Chinese medicine

Identifiers

PMID35042552
PMCPMC8764791
OpenAlexW4205301915

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.