Dataset Information

Development of a method to maximize the transcutaneous electrical nerve stimulation intensity in women with fibromyalgia.

ABSTRACT:

Introduction

Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention clinically used for pain relief. The importance of utilizing the adequate stimulation intensity is well documented; however, clinical methods to achieve the highest possible intensity are not established.

Objectives

Our primary aim was to determine if exposure to the full range of clinical levels of stimulation, from sensory threshold to noxious, would result in higher final stimulation intensities. A secondary aim explored the association of pain, disease severity, and psychological variables with the ability to achieve higher final stimulation intensity.

Methods

Women with fibromyalgia (N=143) were recruited for a dual-site randomized controlled trial - Fibromyalgia Activity Study with TENS (FAST). TENS electrodes and stimulation were applied to the lumbar area, and intensity was increased to sensory threshold (ST), then to "strong but comfortable" (SC1), then to "noxious" (N). This was followed by a reduction to the final stimulation intensity of "strong but comfortable" (SC2). We called this the Setting of Intensity of TENS (SIT) test.

Results

There was a significant increase from SC1 (37.5 mA IQR: 35.6-39.0) to SC2 (39.2 mA IQR: 37.1-45.3) (p<0.0001) with a mean increase of 1.7 mA (95% CI: 1.5, 2.2). Linear regression analysis showed that those with the largest increase between SC1 and N had the largest increase in SC2-SC1. Further, those with older age and higher anxiety were able to achieve greater increases in intensity (SC2-SC1) using the SIT test.

Conclusion

The SC2-SC1 increase was significantly associated with age and anxiety, with greater mean increases associated with older age and higher anxiety. Thus, although all patients may benefit from this protocol, older women and women with elevated anxiety receive the greatest benefit.

SUBMITTER: Vance CG

PROVIDER: S-EPMC6188186 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

Development of a method to maximize the transcutaneous electrical nerve stimulation intensity in women with fibromyalgia.

Vance Carol Gt CG Chimenti Ruth L RL Dailey Dana L DL Hadlandsmyth Katherine K Zimmerman M Bridget MB Geasland Katharine M KM Williams Jonathan M JM Merriwether Ericka N EN Alemo Munters Li L Rakel Barbara A BA Crofford Leslie J LJ Sluka Kathleen A KA

Journal of pain research 20181010

<h4>Introduction</h4>Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention clinically used for pain relief. The importance of utilizing the adequate stimulation intensity is well documented; however, clinical methods to achieve the highest possible intensity are not established.<h4>Objectives</h4>Our primary aim was to determine if exposure to the full range of clinical levels of stimulation, from sensory threshold to noxious, would result in higher final stimu ...[more]

PMID: 30349353

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Project description:PurposeFibromyalgia is a chronic condition characterized by widespread pain and interference with daily activities. The aim of this study is to assess the benefit of transcutaneous electrical nerve stimulation (TENS) for persons diagnosed with fibromyalgia.Patients and methodsAdults meeting diagnostic criteria for fibromyalgia were randomized in a double-blind trial to receive either an active (n=62) or sham (n=57) wearable TENS device for 3-months. Subjects were classified as having lower or higher pain sensitivity by Quantitative Sensory Testing (QST). Patient Global Impression of Change (PGIC, primary outcome) and secondary efficacy measures including Fibromyalgia Impact Questionnaire (FIQR), Brief Pain Inventory (BPI) and painDETECT questionnaire (PDQ) were assessed at baseline, 6-weeks and 3-months. Treatment effects were determined by a mixed model for repeated measures (MMRM) analysis of the intention-to-treat (ITT) population (N=119). A pre-specified subgroup analysis of pain sensitivity was conducted using an interaction term in the model.ResultsNo differences were found between active and sham treatment on PGIC scores at 3-months (0.34, 95% CI [-0.37, 1.04], p=0.351) in the ITT population. However, in subjects with higher pain sensitivity (n=60), PGIC was significantly greater for active treatment compared to sham (1.19, 95% CI [0.24, 2.13], p=0.014). FIQR total score (-7.47, 95% CI [-12.46, -2.48], p=0.003), FIQR pain item (-0.62, 95% CI [-1.17, -0.06], p=0.029), BPI Interference (-0.70, 95% CI [-1.30, -0.11], p=0.021) and PDQ (-1.69, 95% CI [-3.20, -0.18], p=0.028) exhibited significant improvements for active treatment compared to sham in the ITT population. Analgesics use was stable and comparable in both groups.ConclusionThis study demonstrated modest treatment effects of reduced disease impact, pain and functional impairment from wearable TENS in individuals with fibromyalgia. Subjects with higher pain sensitivity exhibited larger treatment effects than those with lower pain sensitivity. Wearable TENS may be a safe treatment option for people with fibromyalgia.Clinicaltrialsgov registrationNCT03714425.

Dataset Information

Development of a method to maximize the transcutaneous electrical nerve stimulation intensity in women with fibromyalgia.

Introduction

Objectives

Methods

Results

Conclusion

Publications

Development of a method to maximize the transcutaneous electrical nerve stimulation intensity in women with fibromyalgia.

Similar Datasets

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