Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial.

INTRODUCTION: Specific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms associated with DPN in diabetes. METHODS AND ANALYSIS: This multicentre, three-armed, participant- and assessor-blind, randomised, sham-controlled trial will recruit 240 eligible participants from four hospitals in China and will randomly assign (1:1:1) them to EA, sham acupuncture (SA) or usual care (UC) group. Participants in the EA and SA groups willl receive either 24-session EA or SA treatment over 8 weeks, followed by an 8-week follow-up period, while participants in the UC group will be followed up for 16 weeks. The primary outcome of this trial is the change in DPN symptoms from baseline to week 8, as rated by using the Total Symptom Score. The scale assesses four symptoms: pain, burning, paraesthesia and numbness, by evaluating the frequency and severity of each. All results will be analysed with the intention-to-treat population. ETHICS AND DISSEMINATION: The protocol has been approved by the Ethics Committee of the Beijing University of Chinese Medicine (Identifier: 2022BZYLL0509). Every participant will be informed of detailed information about the study before signing informed consent. The results of this trial will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR2200061408.

The efficacy and safety of electroacupuncture for diabetic peripheral neuropathy: A protocol for a systematic review and meta-analysis.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is a chronic complication of diabetes mellitus, which is the most common neuropathy worldwide. Owing to the inadequacies of existing treatment methods, managing DPN remains a significant challenge. Studies suggest that electroacupuncture (EA) could potentially serve as a beneficial alternative treatment for this condition. Nevertheless, there is still inadequate proof of its therapeutic effectiveness and safety. As a result, the goal of this protocol is to methodically compile the data pertaining to the effectiveness and security of EA in the management of DPN. METHODS: To find appropriate randomized controlled trials (RCTs), nine reliable databases in the English and Chinese languages will be examined. RevMan5.3 will be used to combine the retrieved data and perform meta-analyses. The methodological quality of the included RCTs will be evaluated using the Cochrane Risk of Bias Assessment 2.0 tool. The Grades of Recommendations, Assessment, Development, and Evaluation (GRADE) system will be utilized to evaluate the degree of strength and certainty of the evidence. We will also perform publication bias, sensitivity and subgroup analyses. DISCUSSION: This protocol describes the intended scope and approach for a forthcoming systematic review and meta-analysis that will inform therapeutic decision-making by offering current information on the efficacy and safety of EA in the treatment of DPN. The results of the study will help standardize strategies for EA in the treatment of DPN.

Electroacupuncture improves peripheral neuropathy by up-regulating Sirt1/PGC-1α/TFAM pathway in type 2 diabetes rats with peripheral neuropathy. / 基于Sirt1/PGC-1α/TFAM通路探讨电针治疗2åž‹ç³–å°¿ç— å‘¨å›´ç¥žç»ç— å˜çš„æœºåˆ¶.

OBJECTIVES: To observe the effect of electroacupuncture (EA) on activation of silent information regulator 1 (Sirt1)/peroxisome proliferator-activated receptor γ coactivator 1α (PGC-1α)/mitochondrial transcription factor A (TFAM) pathway in type 2 diabetes (T2DM) rats with peripheral neuropathy (DPN) , so as to explore its possible mechanisms underlying improvement of DPN. METHODS: Thirty male SD rats were randomly divided into blank control group (n=8) and DPN model group (n=22) which were further divided into model group (n=8) and EA group (n=8) after successful modeling. The model of T2DM was established by high-fat diet and low-dose intraperitoneal injection of streptozocin (35 mg/kg). For rats of the EA group (anesthetized with isoflurane), EA stimulation (2 Hz/15 Hz, 2 mA) was applied to "Tianshu"(ST25) for 20 min, once daily, 6 times a week for 6 weeks. The blood glucose level, body weight, area under curve (AUC) of glucose tolerance test, and hind-paw mechanical pain threshold and thermal pain threshold were observed. The intra-epidermal nerve fiber density (IENFD) of the hind-foot pad was observed by immunofluorescence staining. The motor nerve conduction velocity (MNCV) of the sciatic nerve was measured by using electrophysiological method. H.E. staining was used to observe the histopathological changes of the sciatic nerve after modeling. Transmission electron microscopy (TEM) was used to observe the ultrastructural changes of the sciatic nerve. The protein expressions of energy-related Sirt1, PGC-1α and TFAM in the sciatic nerve was detected by Western blot. RESULTS: Compared with the blank control group, the model group had a higher blood glucose contents and AUC (P<0.001), a slower MNCV (P<0.01), and a decrease in the body weight and in the mechanical and thermal pain thresholds (P<0.001) and IENFD (P<0.001), and in the expression levels of Sirt1, PGC-1α and TFAM (P<0.05, P<0.01). In contrast to the model group, the EA group had a decrease in the blood glucose contents and AUC (P<0.05, P<0.01), and an increase in mechanical and thermal pain thresholds, MNCV, IENFD, and expression levels of Sirt1, PGC-1α and TFAM proteins (P<0.01, P<0.05). In addition, results of histopathological and ultrastructural changes of the sciatic nerve showed more fragmented and disordered distribution of axons on the transverse section, and extensive separation of myelin and axons, uneven myelin thickness, axonal degeneration and irregular shape in the model group, whereas in the EA group, the axons on the transverse section were relatively more dense and more complete, the myelin sheath of the sciatic nerve was relatively uniform, and the axonal shape was relatively regular with relatively milder lesions. CONCLUSIONS: EA up-regulates the expressions of Sirt1, PGC-1α, TFAM in T2DM rats with DPN, which may be associated with its functions in improving and repairing the injured peripheral nerves in rats with DPN.

Electroacupuncture alleviates streptozotocin-induced diabetic neuropathic pain via suppressing phosphorylated CaMKIIα in rats.

Diabetic neuropathic pain (DNP) is a frequent complication of diabetes. Calcium/calmodulin-dependent protein kinase II α (CaMKIIα), a multi-functional serine/threonine kinase subunit, is mainly located in the surface layer of the spinal cord dorsal horn (SCDH) and the primary sensory neurons in dorsal root ganglion (DRG). Numerous studies have indicated electroacupuncture (EA) takes effect in various kinds of pain. In this research, we explored whether CaMKIIα on rats' SCDH and DRG participated in DNP and further explored the mechanisms underlying the analgesic effects of EA. The DNP model in rats was successfully established by intraperitoneal injection of streptozotocin. Certain DNP rats were treated with intrathecal injections of KN93, a CaMKII antagonist, and some of the DNP rats received EA intervention. The general conditions, behaviors, the expressions of CaMKIIα and phosphorylated CaMKIIα (p-CaMKIIα) were evaluated. DNP rats' paw withdrawal threshold was reduced and the expressions of p-CaMKIIα in SCDH and DRG were upregulated compared with the Normal group, while the level of CaMKIIα showed no significance. KN93 attenuated DNP rats' hyperalgesia and reduced the expressions of p-CaMKIIα. We also found EA attenuated the hyperalgesia of DNP rats and reduced the expressions of p-CaMKIIα. The above findings suggest that p-CaMKIIα in SCDH and DRG is involved in DNP. The analgesic effect of EA in DNP might be related to the downregulation of p-CaMKIIα expression level. Our study further supports that EA can be an effective clinical treatment for DNP.

Electroacupuncture efficacy in diabetic polyneuropathy: Study protocol for a double-blinded randomized controlled multicenter clinical trial.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus (T2DM); its diagnosis and treatment are based on symptomatic improvement. However, as pharmacological therapy causes multiple adverse effects, the implementation of acupunctural techniques, such as electroacupuncture (EA) has been suggested as an alternative treatment. Nonetheless, there is a lack of scientific evidence, and its mechanisms are still unclear. We present the design and methodology of a new clinical randomized trial, that investigates the effectiveness of EA for the treatment of DPN. METHODS: This study is a four-armed, randomized, controlled, multicenter clinical trial (20-week intervention period, plus 12 weeks of follow-up after concluding intervention). A total of 48 T2DM patients with clinical signs and symptoms of DPN; and electrophysiological signs in the Nerve Conduction Study (NCS); will be treated by acupuncture specialists in outpatient units in Mexico City. Patients will be randomized in a 1:1 ratio to one of the following four groups: (a) short fibre DPN with EA, (b) short fibre DPN with sham EA, (c) axonal DPN with EA and (d) axonal DPN with sham EA treatment. The intervention will consist of 32 sessions, 20 min each, per patient over two cycles of intervention of 8 weeks each and a mid-term rest period of 4 weeks. The primary outcome will be NCS parameters, and secondary outcomes will include DPN-related symptoms and pain by Michigan Neuropathy Screening Instrument (MNSI), Michigan Diabetic Neuropathy Score (MDNS), Dolour Neuropatique Score (DN-4), Semmes-Westein monofilament, Numerical Rating Scale (NRS) for pain assessment, and the 36-item Short Form Health Survey (SF-36). To measure quality of life and improve oxidative stress, the inflammatory response; and genetic expression; will be analysed at the beginning and at the end of treatment. DISCUSSION: This study will be conducted to compare the efficacy of EA versus sham EA combined with conventional diabetic and neuropathic treatments if needed. EA may improve NCS, neuropathic pain and symptoms, oxidative stress, inflammatory response, and genetic expression, and it could be considered a potential coadjutant treatment for the management of DPN with a possible remyelinating effect. TRIAL REGISTRATION: ClinicalTrials.gov. NCT05521737 Registered on 30 August 2022. International Clinical Trials Registry Platform (ICTRP) ISRCTN97391213 Registered on 26 September 2022 [2b].

Effect of cold application versus transcutaneous nerve stimulation on chemotherapy induced diabetic peripheral neuropathy post mastectomy.

BACKGROUND: The adverse effects of chemotherapy-induced diabetic peripheral neuropathy (CIDPN) are rather prevalent. There is no known pharmaceutical treatment that can stop CIDPN. OBJECTIVE: This study compared the effects of cold application and transcutaneous nerve stimulation (Transcutaneous electrical nerve stimulation (TENS)) on individuals who had undergone mastectomy following CIDPN. SUBJECTS AND METHODS: Between Mars 2021 and September 2021, a randomised controlled experiment was carried out at physical therapy clinics at the Modern University for Technology and Information. 30 patients were randomly split into two equal groups (A and B). Both lower limbs received cold application (Group A) three times per week for 12 weeks and TENS application (Group B) three times each week for 12 weeks. The Visual Analogue Scale and nerve conduction velocity for the sural nerve were used to assess patients before and after 12 weeks of therapy. RESULTS: The results showed that Group A significantly (p < 0.05) decreased pain intensity after treatment by 70.83% compared with Group B by 55.17%. Moreover, Group A improved significantly (p < 0.05) the sural nerve amplitude by 44.12% compared with group B which recorded 26.87%. After treatment, both pain intensity and sural nerve amplitude significantly (p < 0.05) changed between Group A versus Group B. CONCLUSION: Cold application has a better effect on pain in CIDPN post mastectomy.

Effects of acupuncture therapy in diabetic neuropathic pain: A systematic review and meta-analysis.

OBJECTIVE: To evaluate the effectiveness of acupuncture in relieving diabetic neuropathic pain and to establish a more reliable and efficient foundation for acupuncture practice in diabetes care. METHODS: The Chinese National Knowledge Infrastructure, Wanfang database, Chongqing Weipu, Chinese Biomedical Literature Database, PubMed, Embase, and Cochrane Library were all searched for a randomized controlled trial research of acupuncture for DNP. Two researchers independently performed literature screening, quality evaluation, and data extraction. After selecting studies and extracting data, we conducted the data analysis using RevMan 5.4 and Stata 14.0. The quality was assessed using the Cochrane Risk of Bias Assessment Tool. RESULTS: An extensive review of 19 studies involving 1276 patients up to April 29, 2023, found that acupuncture was successful in improving pain intensity [MD= -1.09; 95% CI (-1.28, -0.89), P < 0.00001], clinical efficacy indicating pain changes [RR= 1.22; 95% CI (1.15, 1.29), P < 0.00001], and clinical neuropathy [MD= -1.55; 95% CI ( -3.00, -0.09), P = 0.04] in DNP patients. Quality of life was also improved, with few side effects reported. CONCLUSION: According to this meta-analysis, acupuncture therapy significantly improved the clinical efficacy of pain intensity, pain changes, and clinical neuropathy in patients with DNP, improved the quality of life of patients to a certain extent, and had lower side effects. This discovery provides evidence-based and practical recommendations for the treatment of DNP patients.

Effect of 10.6 µm laser moxibustion on inflammation in diabetic peripheral neuropathy rats.

Diabetic peripheral neuropathy (DPN) is the main cause of disability in diabetes patients but the efficacy of available drugs is poor. Moxibustion is an adjunctive treatment for DPN that can reduce symptoms. The peak value of the far infrared wavelength of 10.6 µm laser moxibustion is close to the infrared radiation spectrum of traditional moxibustion. Its effect is similar to that of moxibustion and does not cause pain, infection or produce irritating smoke. Twenty-four male SD rats were divided into control (Con), DPN, laser moxibustion (LM), and pyrrolidine dithiocarbamate (PDTC) groups (n=6/group). The DPN, LM and PDTC group rats were intraperitoneally injected with 1% streptozotocin (STZ) to induce a model of DPN. LM group rats were irradiated with a laser at bilateral ST36 acupoints for 15 min, once every other day, for 14 days. PDTC group rats were intraperitoneally injected with PDTC once a day. Body weight, blood glucose, and paw withdrawal mechanical threshold (PWMT) were measured and laser speckle imaging (LSI) performed before and after modeling and at 1 and 2 weeks after intervention. Two weeks after intervention, changes in serum interleukin 1ß (IL1ß), interleukin 6 (IL6), tumor necrosis factor α (TNFα) and nerve growth factor (NGF) were analyzed, and the abundance of NF-κB and IκB-α proteins and levels of NF-κB and IκB-α mRNAs in the sciatic nerve were observed. The results showed that 10.6 µm laser moxibustion can relieve pain, improve microcirculation, and alleviate inflammation in DPN rats, possibly via the NF-κB inflammatory pathway.

Effects of Mindfulness Training Combined with Tai Chi in Patients with Diabetic Peripheral Neuropathy.

Diabetic peripheral neuropathy (DPN) is one of the most prevalent chronic complications of diabetes. One of its crucial therapy approaches is mind-body exercise. Recently, various exercise modalities, including stepping, resistance, aerobics, balance, and whole-body vibration, were investigated to construct the most suitable form of exercise for patients with DPN. The purpose of this study is to describe a standard protocol for mindfulness training combined with Tai Chi. The convenience sampling method was used to select 90 patients with DPN who met the inclusion and exclusion criteria from three communities. The three communities were randomly divided into the control group (CG), the Tai Chi group (TCG), and the mindfulness training combined with the Tai Chi group (MTCG). The CG was given routine health education guidance once a month, a total of three times. Based on the CG, the TCG practiced Tai Chi three times; the MTCG received mindfulness training combined with Tai Chi exercise a week for a total of 12 weeks. Before the intervention and 12 weeks after the intervention, the clinical symptoms, neurological function, attention awareness level, pain, and quality of life of the subjects were evaluated by Toronto Clinical Scoring System (TCSS), Mindful Attention Awareness Scale (MAAS), Visual analog scale (VAS), Diabetes Specificity Quality of life Scale (DSQL) and tumor necrosis factor-α. Overall, the addition of mindfulness training to Tai Chi effectively enhances the exercise effects of Tai Chi. Therefore, mindfulness training combined with Tai Chi is worthy of promotion and application.

Efficacy of perineural hypertonic saline injection versus acupoints of foot in the management of diabetic neuropathy: a multicenter, double-blinded randomized controlled trial.

Aim: Painful diabetic polyneuropathy is one of the most common disabling problems worldwide. We aimed to determine if a perineural injection of hypertonic saline compared with foot acupoints decreased the neuropathic pain score in patients with diabetes. Patients & methods/materials: Patients were assigned to receive either perineural or acupoints injection of hypertonic saline 5% in their feet for three weekly sessions. Douleur Neuropathique 4 (DN4) questionnaire for neuropathic pain was assessed. Results: Both groups observed a significant reduction of the DN4 score throughout 8 weeks of follow-up. Conclusion: Both perineural and acupoints hypertonic saline injections of the foot could improve neuropathic pain in patients with diabetes.

We conducted a double blinded randomized clinical trial in 30 diabetic patients with painful neuropathic pain to determine if a perineural injection of hypertonic saline compared with foot acupoints decreased the neuropathic pain score in patients with diabetes. Subjects were assigned to receive either perineural (near Sural, Saphenous and Tibial nerves) or acupoints (ST41, ST44, GB40) injection of hypertonic saline 5% in one foot, keeping the other foot as control. Each patient underwent an injection at baseline followed by two injections, one week apart. The primary outcome was an assessment tool for neuropathic pain, called Douleur Neuropathique 4 questionnaire (DN4) score. It was measured before, during and 8 weeks after intervention. A significant reduction of DN4 score in perineural group and in the acupoint group throughout an 8 weeks follow-up was observed compared with the contralateral foot which was considered as the control group. The study revealed no significant differences between the perineural and the acupoints groups according to DN4 score. In conclusion, both perineural and acupoints of the foot hypertonic saline injections could improve neuropathic pain in diabetic patients with neither being superior to each other. The Clinical Trial Registration number was IRCT20170517034008N1.

Early detection and treatment device for diabetic foot neuropathy.

BACKGROUND: Diabetic foot neuropathy is one of the complications of diabetes that affects around 50% of diabetic people. Because peripheral neuropathy involves nerve loss around the foot areas, patients with diabetic neuropathy frequently lose sensation in their feet while walking or standing. Furthermore, since sensory nerves are damaged, the area that holds the majority of the foot pressure and temperature is at high risk of injury. If not diagnosed and treated properly, it can cause foot injury and eventually lead to edema, gangrene, ulcers, amputation, and even death. There are now several techniques of detecting diabetic neuropathy, but they are limited in their availability, cost-effectiveness, and complexity. AIMS: The primary goal of this research was to develop devices for early detection and treatment of diabetic foot neuropathy. METHODS: The proposed device combines a foot pressure monitoring method and a foot temperature measurement method to diagnose diabetic neuropathy early on, with red light therapy added as a treatment method. For 2 weeks, the device measures the patient's foot pressure and temperature, and light therapy is provided if a change in pressure or temperature at a specific area is observed. RESULTS: The device prototype was successfully developed, and numerous tests were carried out in accordance with the design specifications. For pressure measurement and temperature measurement, measurement accuracy of 99.05% and 99.30%, respectively, were attained. CONCLUSION: The early detection and treatment device developed in this study could be used at home by diabetic patients as well as in hospitals to test for and treat diabetic foot neuropathy at an early stage. The device incorporates two different methods of diabetic foot neuropathy detection with high measurement accuracy which makes it suitable for use in resource-limited areas at low cost. The incorporation of red light therapy together with the two methods of diabetic neuropathy detection gives another unique feature for our device.

The efficacy and safety of traditional Chinese medicine physiotherapy combined with acupoint injection on diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis.

BACKGROUND: The efficacy and safety of traditional Chinese medicine physiotherapy combined with acupoint injection in treating diabetic peripheral neuropathy remains unknown. As a result, we will conduct a systematic review and meta-analysis to assess the evidence. METHODS: We will look for pertinent randomized controlled trials in the following databases: China National Knowledge Infrastructure, WanFangData, Chinese biological medical database, Medline, Cochrane Library, PubMed, and Embase up to January 2022. Following the standards of Cochrane Review 6.2, 2 researchers independently evaluated the quality of the evidence in the relevant papers. Data analysis will be conducted by using Review Manager 5.4, including statistical analysis, subgroup analysis, making forest plot and funnel chart. RESULTS: The results will be submitted to a peer-reviewed journal. CONCLUSION: The research will verify the safety and efficacy of traditional Chinese medicine physiotherapy in combination with acupoint injection for diabetic peripheral neuropathy.

Painful Diabetic Neuropathy - Spinal Cord Stimulation, Peripheral Nerve Stimulation, Transcutaneous Electrical Nerve Stimulation, and Scrambler Therapy: A Narrative Review.

BACKGROUND: First-line medications for the treatment of painful diabetic neuropathy (PDN) are associated with a substantial rate of discontinuation due to adverse effects or insufficient efficacy. Neuromodulation techniques have been used for PDN, but a comprehensive review of the literature that incorporates several distinct device categories has yet to be undertaken. OBJECTIVES: We aimed to summarize the evidence regarding 4 major types of neuromodulation devices for the treatment of PDN. We focused on spinal cord stimulators (SCS), peripheral nerve stimulators (PNS), transcutaneous electrical nerve stimulators (TENS), and scrambler therapy devices (ST) because they are often used for refractory neuropathic pain. STUDY DESIGN: Narrative Review. METHODS: A comprehensive and reproducible literature search was performed using PubMed with no search restrictions applied. The available Medical Subject Headings were used. Inclusion criteria included prospective studies, retrospective studies, case series, and case reports indexed from database inception to the search date (September 14, 2021). RESULTS: Seventeen studies met inclusion criteria, 10 of which were regarding SCS. Only 3 of the 10 were randomized controlled trials. We found no studies assessing contemporary PNS. Four studies assessed TENS, but the devices varied widely in voltages and waveforms. Two case reports described ST. LIMITATIONS: Potential selection bias due to the nature of a narrative review, although a reproducible search strategy was utilized. Several neuromodulation modalities have minimal published evidence available. CONCLUSIONS: The evidence for neuromodulation devices for the treatment of PDN mostly comprises open-label prospective trials or case reports. SCS has the most volume of evidence for efficacy. Studies regarding TENS show mixed results, possibly due to numerous device varieties. PNS and ST may hold promise based on their proposed mechanisms of action, but prospective controlled trials are needed.

Evaluation of Mindfulness Training Combined with Aerobic Exercise on Neurological Function and Quality of Life in Patients with Peripheral Neuropathy Type 2 Diabetes Mellitus.

Objective: To investigate the effect of mindfulness training on neurological function and quality of life in patients with type 2 diabetic peripheral neuropathy. Methods: This study selected 120 patients with type 2 diabetic peripheral neuropathy and randomly divided them into three independent subgroups according to different training methods: mindfulness meditation group (MM), aerobic exercise group (AE), and mindfulness combined with aerobic exercise group. (MMAE). The three groups were analyzed for SNCV and MNCV velocities, MAAS and TCSS scores, neurological symptom scores, neurological sign scores, and quality of life. Results: Before treatment, SNCV and MNCV were not significantly significant (P > 0.05), but after treatment, SNCV and MNCV were significantly higher, and the MMAE group changed more significantly (P < 0.05); before treatment, MAAS and TCSS scores were not significant (P > 0.05), but after treatment, MAAS scores were significantly higher, TCSS scores were significantly lower, and more significantly in MMAE; the difference was significant (P < 0.05); before treatment, there was no statistical significance of the neurological signs score (P > 0.05); after treatment, the neurological symptoms score and neurological signs score were significantly reduced, and the changes in the MMAE group were statistically significant (P < 0.05); there was no significant difference in the quality of life score before treatment (P > 0.05), and the quality of life score in the MMAE group was significantly increased (P < 0.05). Conclusion: Mindfulness training combined with aerobic exercise has an ideal therapeutic effect on patients with type 2 diabetic peripheral neuropathy, and has a very important role in improving the neurological function and quality of life of the patients. It is a safe and effective treatment method. Therefore, mindfulness training combined with aerobic exercise is worthy of promotion and application.

TENS and EMS Treatment for Diabetic Peripheral Neuropathy.

Context: Diabetic peripheral neuropathy (DPN) is a common complication occurring in both type 1 and type 2 diabetics. DPN may result in foot ulceration or lower-limb amputation. Objective: This case was undertaken to evaluate the efficacy of ReBuilder® therapy in the treatment of diabetic peripheral neuropathy. Methods: The case report is based on 3 selected patients, 2 males and 1 female. Each patient continued being managed by his/her primary care physician. No changes to allopathic medicine or diet were advised by our team. In addition to the allopathic therapy, we added ReBuilder® therapy, low level light therapy, vibration therapy and supplementation. The treatment period ranged from 17 to 20 weeks. Conclusion: The data presented here show promise for future, larger, controlled studies on the use of ReBuilder® devices for the treatment of diabetic peripheral neuropathy pain.

Effect of Cognitive-Behavioral Therapy or Mindfulness Therapy on Pain and Quality of Life in Patients with Diabetic Neuropathy: A Systematic Review and Meta-Analysis.

OBJECTIVES: This study aimed to evaluate the effectiveness of cognitive behavioral therapy (CBT) and mindfulness therapy (MT) for pain relief and quality of life (QOL) in patients with diabetic neuropathy. REVIEW/ANALYSIS METHODS: Four databases were systematically searched from their respective inception dates to 29 June 2021. Relevant randomized controlled trials (RCTs) were screened and assessed for risk of bias. Eight RCTs evaluating CBT or MT were included. Statistical analysis was performed using Review Manager 5.4. RESULTS: Eight RCTs involving 384 patients with painful diabetic neuropathy (PDN) tested psychological interventions, including three CBT and five MT studies. The results showed that patients' pain severity (standardized mean difference [SMD] = -0.60, 95% confidence interval [CI; -0.93 to -0.27], P = .0003) and QOL (SMD = -0.43, 95% CI [-0.83 to -0.04], p = .03) were improved immediately after treatment. Besides, the pain intensity (SMD = -0.67, 95% CI [-1.37 to 0.03], p = .06), pain interference (SMD = -0.75, 95% CI [-1.20 to -0.30], p = .001) and depressive symptoms (SMD = -0.62, 95% CI [-0.96 to -0.28], p = .0003) were superior to the control group after follow up. The subgroup analysis results of different intervention type showed that the CBT group could immediately improve pain (SMD = -0.44, 95% CI [-0.78 to -0.10], p = .01) after treatment. However, there was no statistically significant difference in the CBT group after follow-up (SMD = -0.15, 95% CI [-0.52 to 0.22], p = .42). CONCLUSIONS: Cognitive behavioral therapy or MT is effective for treating pain in patients with diabetic peripheral neuropathy, improving the QOL, and reducing depressive symptoms. However, large-scale, multi-centre, rigorously designed RCTs are needed to further verify the long-term effects.

The efficacy and safety of massage adjuvant therapy in the treatment of diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The incidence of diabetic peripheral neuropathy (DPN) is increasing year by year. If patients cannot receive timely and effective treatment, DPN may lead to diabetic foot ulcers or even amputation. This risk factor has been widely concerned around the world. Massage, as a non-invasive physical therapy method, is gradually being applied in the adjuvant treatment of DPN. However, there is no systematic review of the adjuvant treatment of DPN by massage. Our study will explore the effectiveness and safety of massage applied in DPN. METHODS: Eight electronic databases (PubMed, Cochrane, Web of Science, Sinomed, Embase, China National Knowledge Infrastructure, WanFang Data, Chongqing VIP Information) will be searched by our computer on February 9, 2022. A randomized controlled trial (RCT) of adjuvant massage therapy for DPN was screened. Primary outcome measures: efficiency, nerve conduction velocity. Secondary outcome measures: pain, blood glucose, and incidence of adverse reactions. The quality of the study was evaluated by two researchers using the RCT bias risk assessment tool in the Cochrane review manual Handbook5.4, and meta-analysis was performed by RevMan5.4 software. RESULTS: RCTs will be used to evaluate the clinical efficacy of massage adjuvant therapy in DPN. CONCLUSION: This study will provide evidence-based evidence for the safety and effectiveness of massage adjuvant therapy in DPN. PROTOCOL REGISTRATION NUMBER: INPLASY202220025.

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

BACKGROUND: Diabetic 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. METHODS: This 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 REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000029329 . Registered on 25 January 2020.

Current Strategies for the Management of Painful Diabetic Neuropathy.

The development of painful diabetic neuropathy (PDN) is a common complication of chronic diabetes that can be associated with significant disability and healthcare costs. Prompt symptom identification and aggressive glycemic control is essential in controlling the development of neuropathic complications; however, adequate pain relief remains challenging and there are considerable unmet needs in this patient population. Although guidelines have been established regarding the pharmacological management of PDN, pain control is inadequate or refractory in a high proportion of patients. Pharmacotherapy with anticonvulsants (pregabalin, gabapentin) and antidepressants (duloxetine) are common first-line agents. The use of oral opioids is associated with considerable morbidity and mortality and can also lead to opioid-induced hyperalgesia. Their use is therefore discouraged. There is an emerging role for neuromodulation treatment modalities including intrathecal drug delivery, spinal cord stimulation, and dorsal root ganglion stimulation. Furthermore, consideration of holistic alternative therapies such as yoga and acupuncture may augment a multidisciplinary treatment approach. This aim of this review is to focus on the current management strategies for the treatment of PDN, with a discussion of treatment rationale and practical considerations for their implementation.