Dataset Information

Multicenter, randomized, double-blind, controlled trial of transcutaneous electrical nerve stimulation for pancreatic cancer related pain.

ABSTRACT:

Background

Up to 80% of patients with pancreatic cancer experience abdominal and back pain. Although pharmacologic medications provide some relief, many report inadequate analgesia and adverse effects. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive physical modality and had been widely applied for pain relieving, yet no study has investigated the effectiveness of TENS for pain in pancreatic cancer.

Methods

Eligible patients were randomly assigned in a 1:1 ratio to TENS group or control group. The primary outcome was percentage change of numerous rating scale (NRS) after treatment. Secondary outcomes included percentage change of analgesic medication consumption and effect on constipation and poor appetite.

Results

One hundred seventy-one patients were recruited (84 to control group and 87 to TENS group). NRS in TENS group has been largely decreased 77.9% right after treatment and 27.1% in 2?hours, before applying any analgesic medication, while that in control group was slightly downregulated right after treatment but gave a trend to increase at 1, 2, and 3?hours. When comparing both groups, pain was significantly well controlled without analgesic medication supplement in TENS group at 0?hour (difference in mean percent change in NRS?=?50.0 [95% CI, 50-51.4], P?ConclusionsTENS reduces pain without increase analgesic medication consumption in patients with pancreatic cancer pain. It provides an alternative therapy for pain in pancreatic cancer.

Clinical trial registration

This study was registered at ClinicalTrials.gov, identifier NCT03331055.

SUBMITTER: He L

PROVIDER: S-EPMC7870216 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Multicenter, randomized, double-blind, controlled trial of transcutaneous electrical nerve stimulation for pancreatic cancer related pain.

He Lihua L Tan Keping K Lin Xianming X Yi Hui H Wang Xueliang X Zhang Jiangsong J Lin Jietao J Lin Lizhu L

Medicine 20210201 5

<h4>Background</h4>Up to 80% of patients with pancreatic cancer experience abdominal and back pain. Although pharmacologic medications provide some relief, many report inadequate analgesia and adverse effects. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive physical modality and had been widely applied for pain relieving, yet no study has investigated the effectiveness of TENS for pain in pancreatic cancer.<h4>Methods</h4>Eligible patients were randomly assigned in a 1:1 rat ...[more]

PMID: 33592831

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Project description:ObjectiveFibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate if using TENS during activity would improve movement-evoked pain and other patient-reported outcomes in women with FM.MethodsParticipants were randomly assigned to receive active TENS (n = 103), placebo TENS (n = 99), or no TENS (n = 99) and instructed to use it at home during activity 2 hours each day for 4 weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2-125 Hz) at the highest tolerable intensity. Participants rated movement-evoked pain (primary outcome measure) and fatigue on an 11-point scale before and during application of TENS. The primary outcome measure and secondary patient-reported outcomes were assessed at baseline (time of randomization) and at 4 weeks.ResultsAfter 4 weeks, a greater reduction in movement-evoked pain was reported in the active TENS group versus the placebo TENS group (group mean difference -1.0 [95% confidence interval -1.8, -0.2]; P = 0.008) and versus the no TENS group (group mean difference -1.8 [95% confidence interval -2.6, -1.0]; P < 0.0001). A reduction in movement-evoked fatigue was also reported in the active TENS group versus the placebo TENS group (group mean difference -1.4 [95% confidence interval -2.4, -0.4]; P = 0.001) and versus the no TENS group (group mean difference -1.9 [95% confidence interval -2.9, -0.9]; P = <0.0001). A greater percentage of the patients in the active TENS group reported improvement on the global impression of change compared to the placebo TENS group (70% versus 31%; P < 0.0001) and the no TENS group (9%; P < 0.0001). There were no TENS-related serious adverse events, and <5% of participants experienced minor adverse events from TENS.ConclusionAmong women who had FM and were on a stable medication regimen, 4 weeks of active TENS use compared to placebo TENS or no TENS resulted in a significant improvement in movement-evoked pain and other clinical outcomes. Further research is needed to examine effectiveness in a real-world setting to establish the clinical importance of these findings.

Project description:BackgroundTranscutaneous electrical nerve stimulation (TENS) is commonly used for the management of pain; however, its effects on several pain and function measures are unclear.ObjectiveThe purpose of this study was to determine the effects of high-frequency TENS (HF-TENS) and low-frequency TENS (LF-TENS) on several outcome measures (pain at rest, movement-evoked pain, and pain sensitivity) in people with knee osteoarthritis.DesignThe study was a double-blind, randomized clinical trial.SettingThe setting was a tertiary care center.ParticipantsSeventy-five participants with knee osteoarthritis (29 men and 46 women; 31-94 years of age) were assessed.InterventionParticipants were randomly assigned to receive HF-TENS (100 Hz) (n=25), LF-TENS (4 Hz) (n=25), or placebo TENS (n=25) (pulse duration=100 microseconds; intensity=10% below motor threshold).MeasurementsThe following measures were assessed before and after a single TENS treatment: cutaneous mechanical pain threshold, pressure pain threshold (PPT), heat pain threshold, heat temporal summation, Timed "Up & Go" Test (TUG), and pain intensity at rest and during the TUG. A linear mixed-model analysis of variance was used to compare differences before and after TENS and among groups (HF-TENS, LF-TENS, and placebo TENS).ResultsCompared with placebo TENS, HF-TENS and LF-TENS increased PPT at the knee; HF-TENS also increased PPT over the tibialis anterior muscle. There was no effect on the cutaneous mechanical pain threshold, heat pain threshold, or heat temporal summation. Pain at rest and during the TUG was significantly reduced by HF-TENS, LF-TENS, and placebo TENS.LimitationsThis study tested only a single TENS treatment.ConclusionsBoth HF-TENS and LF-TENS increased PPT in people with knee osteoarthritis; placebo TENS had no significant effect on PPT. Cutaneous pain measures were unaffected by TENS. Subjective pain ratings at rest and during movement were similarly reduced by active TENS and placebo TENS, suggesting a strong placebo component of the effect of TENS.

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

Multicenter, randomized, double-blind, controlled trial of transcutaneous electrical nerve stimulation for pancreatic cancer related pain.

Background

Methods

Results

Clinical trial registration

Publications

Multicenter, randomized, double-blind, controlled trial of transcutaneous electrical nerve stimulation for pancreatic cancer related pain.

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