Research

The Journal of Foot and Ankle Surgery : Official Publication of the American College of Foot and Ankle Surgeons [1997, 36(4):260-263]

Is electrical stimulation effective in reducing neuropathic pain in patients with diabetes?

PMID:9298439

Armstrong, DG; Lavery, LA; Fleischli, JG; Gilham,

Department of Orthopaedics, University of Texas Health Science Center, San Antonio 78284, USA.

1997/01

Pulsed-dose electrical stimulation is evaluated as an analgesic modality in patients-with painful diabetic neuropathy. Using a knitted silver-plated nylon/dacron stocking electrode, patients were given electrical stimulation over the course of 1 month. Pain was measured weekly, using a 10-cm. visual analog scale. Pain measurements at the end of the 4-week therapy and at 1 month after complete discontinuation of therapy were significantly lower than at the initiation of therapy. The results of this pilot study suggest that nocturnal doses of pulsed-electrical stimulation may be effective in alleviating subjective, burning, diabetic neuropathic pain in a population consisting of patients with grossly intact protective sensation, relatively good distal vascular perfusion and less than ideal glucose control. To the authors’ knowledge, this is the first analytic report of pulsed-dose electrical nerve stimulation delivered through a stocking electrode for treatment of symptomatic diabetic neuropathy in medical literature.

J Diabetes Sci Technol. 2013 Sep 1;7(5):1202-9.

Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy.

Thakral G1, Kim PJ, LaFontaine J, Menzies R, Najafi B, Lavery LA

BACKGROUND:

The objective of this review is to evaluate the use of electrical stimulation to treat diabetic neuropathy. Application of electrical stimulation may provide a novel treatment option for large and small fiber neuropathy in persons with diabetes. Large and small nerve neuropathy alters pain, proprioception, touch perception, and motor function, which cause burning foot pain and serve as protective mechanisms from ulcerations.

METHODS:

A content search for clinical trials involving electrical stimulation, neuropathy, and diabetes was conducted through PubMed. Randomized clinical trials and prospective studies with outcome measures affecting the lower extremity function were selected for review.

RESULTS:

We identified eight studies in which electrical stimulation was used to treat diabetic neuropathy. Six studies evaluated small fiber neuropathy. Two studies evaluated patients with both small and large fiber neuropathy and reported significant improvement in vibration and monofilament testing and reduction in symptoms in the electrical stimulation treatment group. Six of the eight painful neuropathy studies identified significant improvement in symptoms. There were no studies that evaluated electrical stimulation to treated diabetic motor neuropathy, fall prevention or postural instability.

CONCLUSIONS:

Electrical stimulation may be an effective alternative and adjunctive therapy to current interventions for diabetic peripheral neuropathy.

J Foot Ankle Surg. 1998 Sep-Oct;37(5):396-400; discussion 447-8.

The benefit of electrical stimulation to enhance perfusion in persons with diabetes mellitus.

Peters EJ1, Armstrong DG, Wunderlich RP, Bosma J, Stacpoole-Shea S, Lavery LA.

Abstract

The purpose of this study was to evaluate the effect of galvanic electrical stimulation on vascular perfusion in diabetic patients. Nineteen subjects with diabetes were enrolled. Eleven subjects (57.9%) were diagnosed with impaired peripheral perfusion based upon their initial transcutaneous oximetry values (< 40 mm Hg). The subjects were studied over a 2-day period. On the 1st day, one foot was electrically stimulated for four 60-minute periods by an external electrical stimulation device. Vascular perfusion of both feet was assessed before and after the sessions of electrical stimulation. On the 2nd day, no electrical stimulation was applied and noninvasive vascular measurements were repeated. For the 1st hour, transcutaneous oxygen pressure was measured continuously during stimulation at the lateral aspect of the leg. Subsequently, perfusion between the periods of stimulation was measured on the dorsum of the foot with both transcutaneous oximetry and laser Doppler flowmetry after each stimulation period. In the group with impaired peripheral perfusion, a significant rise in tissue oxygenation as compared to the control measurements was measured during the first 5 minutes of stimulation (p < .040). For those without vascular disease (TcpO2 > 40 mm Hg) however, there was not a significant increase compared to baseline (p = .280). After the periods of stimulation, the stimulated feet did not show any higher perfusion levels than the control feet. Patterns in perfusion during the day, as measured by laser Doppler flowmetry, were similar in the tested feet and in the controls. These data suggest that external subsensory electrical stimulation induces a transient rise in skin perfusion in persons with diabetes and impaired peripheral perfusion.

Transcutaneous Electrical Nerve Stimulation, Pregabalin and Their Combination in Patients with Painful Diabetic Neuropathy: Effects on Pain and Quality of Life.

Moharic M, Marincek C, Vidmar G, Burger H

Metka Mohari?, Department of Physical and Rehabilitation Medicine, Linhartova 51, SI-1000 Ljubljana, Slovenia,

Phone +386 1 4758441, Fax +386 1 4376589, E-mail metka.moharic@mf.uni-lj.si

Abstract

Background:

Peripheral neuropathy is a common complication of diabetes, whereby pain control is the most difficult issue. The outcomes of existing treatment options are far from satisfactory and the results of studies comparing them are indecisive. Hence, we aimed at comparing the effect of treating pain with transcutaneous electrical nerve stimulation (TENS), pregabalin

and their combination in patients with painful diabetic neuropathy (PDN), including the quality-of-life aspect.

Methods:

A randomized clinical trial was planned with 69 PDN patients divided into three equally sized groups receiving TENS, pregabalin or combined treatment. Because of early dropouts from the pregabalin and combination group due to side effects, randomization was

abandoned during recruitment phase and all remaining patients were assigned to TENS, resulting in group sizes of 46, 5 and 14, respectively. Assessments for pain relief and quality of life were performed at baseline, at the end of three-week treatment, and one month after the end of treatment.

Results:

Observed treatment effects did not differ between the groups. Statistically significant and clinically meaningful reduction of average and worst pain was achieved. Patients rated their quality of life better especially in the bodily pain domain of Short Form-36. One month post treatment, all observed effects were still present. Pain reduction correlated mainly with improvement of physical functioning domain.

Conclusions:

Since TENS did not differ in efficacy from pregabalin and combined treatment, and does not have side effects, it appears to be a viable addition or even alternative to other analgesic modalities in PDN.

Diabetes Nutr Metab. 2004 Jun;17(3):163-8.

Impact of low frequency transcutaneous electrical nerve stimulation on symptomatic diabetic neuropathy using the new Salutaris device.

Forst T1, Nguyen M, Forst S, Disselhoff B, Pohlmann T, Pfützner A.

Abstract

In a double blind, randomised study, 19 patients suffering from mild-to-moderate symptomatic diabetic neuropathy (Total Symptom Score, NTSS 4-16) received either treatment with the new transcutaneous electrical nerve stimulation (TENS) device “Salutaris” (verum group) or a placebo treatment with an identical but electrically inactive device (placebo group). Stimulation pads were placed at the anatomical localisation of the peroneal nerve and stimulation was performed using a low frequency mode. At baseline (V1), after 6 (V2), and 12 (V3) wk of treatment, the patients’ symptoms were registered using the new total symptom score (NTSS-6) and a visual analogue scale (VAS). In addition, sensory nerve thresholds (temperature, vibration, pain) and microvascular function were measured at the lower limb at baseline and after 12 wk of treatment. Active TENS-treatment resulted in a significant improvement in NTSS-6 score after 6 wk (-42%) and after 12 wk (-32%) of treatment (baseline: 10.0+/-3.3, 6 wk: 5.8+/-5.0, p<0.05; 12 wk: 6.8+/-3.9, p=0.05; placebo group: baseline: 7.6+/-3.1; 6 wk: 8.1+/-5.1, n.s.; 12 wk: 6.5+/-6.1, n.s.). Subanalysis of the different qualities of the NTSS-score revealed an improvement in numbness (2.2+/-1.0 to 1.6+/-1.3; p<0.03); lancinating pain (1.6+/-1.1 to 0.6+/-0.9; p<0.02) and allodynia (1.4+/-1.6 to 0.5+/-1.0; p<0.05). Also, a significant improvement in the VAS rating was found after 6 wk of TENS therapy (19.8+/-5.0 to 14.4+/-9.6; p<0.05), while no change was observed in the placebo arm. In conclusion, our study indicates that the new TENS device “Salutaris” is a convenient, non-pharmacological option for primary or adjuvant treatment of painful diabetic neuropathy.

The effectiveness of analgesic electrotherapy in the control of pain associated with diabetic neuropathy

Szopinski J,Georg Lochner G, & Szopinska H

Pages 12-18 | Published online: 12 Aug 2014

Abstract

Objective:

To investigate the usefulness of transcutaneous electrical nerve stimulation (TENS) and electroacupuncture in managing the pain associated with diabetic neuropathy.

Research Design and Methods:

A randomized, comparative, placebo controlled study was performed on a group of 100 patients diagnosed with diabetic neuropathy, at the 4th Department of Internal Medicine, Silesian Medical Academy, Katowice, Poland and the Pain Clinic, Mayo Medical Centre of South Africa, Johannesburg. The change in pain perceived was assessed after a course of analgesic electrotherapy using a visual analogue scale as well as changes in use of analgesics and walking ability.

Results:

The level of pain reported and use of analgesics dropped significantly after the electrotherapy course, compared to the control group. Walking ability improved significantly in patients reporting pain relief. There was no statistically significant difference between the results obtained in the Type 1 and Type 2 patients. Electrotherapy did not produce any side effects.

Conclusions:

Analgesic electrotherapy, which includes electroacupuncture and TENS, is an effective, affordable and convenient treatment of pain associated with diabetic neuropathy. If correctly applied, analgesic electrotherapy does not produce any side effects.

Diabetes Technol Ther. 1999 Spring;1(1):77-80.

Transcutaneous electrostimulation: emerging treatment for diabetic neuropathic pain.

Alvaro M1, Kumar D, Julka IS.

Abstract

Three independent studies utilizing transcutaneous electrical nerve stimulation to relieve diabetic peripheral neuropathic pain were reviewed. The proprietary equipment, an H-wave machine, administered all electrotherapy. The first two studies assessed the efficacy of electrotherapy alone and electrotherapy with amitriptyline. The treated electrotherapy group reported an overall greater reduction of symptoms, 52% with 2-3 weeks of active treatment. Amitriptyline alone produced a 26% reduction of pain after 4 weeks. The addition of active electrotherapy to amitriptyline produced a 66% reduction of pain. The final study looked at patients who have utilized electrotherapy for over one year. A reported 44% improvement of symptoms was attained with continuous electrotherapy treatment. The data also suggested that a maintenance treatment protocol for long-term pain relief would have to be developed.

J Rehabil Med. 2010 Apr;42(4):289-95. doi: 10.2340/16501977-0554.

Electrotherapy for the treatment of painful diabetic peripheral neuropathy: a review.

Pieber K1, Herceg M, Paternostro-Sluga T.

Abstract

OBJECTIVE:

To review different types of electrotherapy for the treatment of painful diabetic peripheral neuropathy.

METHODS:

A structured search of the electronic database MEDLINE was performed from the time of its initiation to July 2009. Articles in English and German were selected.

RESULTS:

The efficacy of different types of electrotherapy for painful diabetic peripheral neuropathy has been evaluated in 15 studies; the effects of transcutaneous electrical nerve stimulation are consistent. The beneficial effects of prolonged use have been reported in three large studies and one small study. The effects of frequency-modulated electromagnetic neural stimulation were assessed in one large study, and a significant reduction in pain was reported. Treatment with pulsed and static electromagnetic fields has been investigated in two small and three large studies, and analgesic benefits have been reported. In one large study focusing on pulsed electromagnetic fields, no beneficial effect on pain was registered. Only small studies were found concerning other types of electrotherapy, such as pulsed-dose electrical stimulation, high-frequency external muscle stimulation or high-tone external muscle stimulation. The conclusions drawn in these articles are diverse. Shortcomings and problems, including a poor study design, were observed in some.

CONCLUSION:

Further randomized, double-blind, placebo-controlled studies comprising larger sample sizes, a longer duration of treatment, and longer follow-up assessments are required.

Diabetes Res Clin Pract. 2010 Jul;89(1):10-5. doi: 10.1016/j.diabres.2010.03.021. Epub 2010 May 26.

Effect of transcutaneous electrical nerve stimulation on symptomatic diabetic peripheral neuropathy: a meta-analysis of randomized controlled trials.

Jin DM1, Xu Y, Geng DF, Yan TB.

Abstract

AIMS:

To evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) on diabetic peripheral neuropathy (DPN).

METHODS:

Randomized controlled trials (RCTs) comparing TENS with routine care, pharmacological interventions or placebo devices on patients with symptomatic DPN, were identified by electronic and manual searches. Studies were selected and available data were extracted independently by two investigators. Meta-analysis was performed by RevMan 4.2.8 software.

RESULTS:

Three RCTs involving 78 patients were included in this study. The reductions in mean pain score were significantly greater in TENS group than in placebo TENS group in 4 weeks and 6 weeks follow-up [4 weeks, SMD-5.37, 95% CI (-6.97, -3.77); 6 weeks, SMD-1.01, 95% CI (-2.01, -0.01)], but not in 12 weeks follow-up [SMD-1.65, 95% CI (-4.02, 0.73)]. TENS therapy was associated with significantly subjective improvement in overall neuropathic symptoms in 12 weeks follow-up [WMD-0.18, 95% CI (-0.32, -0.051)]. No TENS-related adverse events were registered in TENS group.

CONCLUSIONS:

TENS therapy may be an effective and safe strategy in treatment of symptomatic DPN. Due to small sample and short-term treatment duration, large multi-centre RCTs are needed to further evaluate the long-term effect of TENS on DPN.

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