Dataset Information

Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial.

ABSTRACT: Primary dysmenorrhea (PD) is a painful menstruation that can persist for the duration of a woman's fertile life. Non-steroidal anti-inflammatory drugs, hormonal therapy, physiotherapy techniques, etc., are the main treatments. The main objective of this study is to evaluate the effectiveness of transcutaneous posterior tibial nerve stimulation (TTNS) in PD patients. The study will consist of a single-blind randomized clinical trial, parallel-assigned with two arms. Women with PD (18-43 years) with regular menstrual cycles and at least 4 points in VAS will be randomly divided into experimental (TTNS) and placebo (simulated stimulation) groups during 12 treatment sessions (1 session/week) and several follow-ups: monthly during treatment and 1, 3 and 6 months after. Maximum and mean pain intensity, pain duration, pain severity, number of anti-inflammatory drugs, quality of life, sleep quality, overall improvement, treatment satisfaction and secondary effects will be measured once a month every 6 months and at 3 and 6 months. The Student's t-test for independent samples or the Mann-Whitney U test will be used. The literature shows effective physiotherapeutic techniques for PD in the short term, which do not act on causes and have limitations. The TTNS technique can be used in transcutaneous and percutaneous modalities, with similar effectiveness, but the transcutaneous causes less discomfort. TTNS modulates pain, and long-term benefits could be achieved at low cost and without patient discomfort.

SUBMITTER: Correyero-Leon M

PROVIDER: S-EPMC10252587 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial.

Correyero-León Marta M Llamas-Ramos Rocío R Calvo-Rodrigo Javier J Alvarado-Omenat Jorge Juan JJ Llamas-Ramos Inés I

Healthcare (Basel, Switzerland) 20230602 11

Primary dysmenorrhea (PD) is a painful menstruation that can persist for the duration of a woman's fertile life. Non-steroidal anti-inflammatory drugs, hormonal therapy, physiotherapy techniques, etc., are the main treatments. The main objective of this study is to evaluate the effectiveness of transcutaneous posterior tibial nerve stimulation (TTNS) in PD patients. The study will consist of a single-blind randomized clinical trial, parallel-assigned with two arms. Women with PD (18-43 years) wi ...[more]

PMID: 37297773

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Project description:Primary dysmenorrhea (PD) is a common gynecological disorder characterized by cramping pain in the lower abdomen during menstruation, in the absence of identifiable pathology. While Transcutaneous Electrical Nerve Stimulation (TENS) is used to promote PD pain relief, there is still a need to understand the parameters and cost-effectiveness of this intervention. As such, this study aims to disclose a study that will evaluate the effectiveness and cost-effectiveness of TENS on pain intensity in women with PD. This is a protocol for an assessor-blinded randomized controlled trial that includes 174 women with PD, >18 years old, with menstrual pain greater than or equal to four points in the Numerical Rating Scale. Participants will be randomized into three groups (active TENS, placebo TENS, and educational booklet). Participants allocated to the active TENS group will receive electrical stimulation (F = 100 Hz, pulse duration = 200 μs, for 30 min). In contrast, the placebo TENS group will receive placebo stimulation (same parameters, but for only 30 s, and then the current will be ramped off over a 15-s time frame) for three consecutive months during menstruation. Participants allocated to the educational booklet group will receive instructions about health promotion and education actions related to PD. A blinded assessor will evaluate the pain intensity (Numerical Rating Scale), presenteeism (Stanford Presenteeism Scale), Health-Related Quality of Life (Short-Form 6 dimensions and SF-36), and health costs of menstrual pain. This is the first study to propose a health economic evaluation while assessing the benefits of using TENS to treat PD symptoms. It is hypothesized that active TENS will be more effective than placebo TENS or the educational booklet in improving clinical outcomes in the short-, medium- and long-term. The study will also provide information about the cost-effectiveness of TENS, which can be used by policy makers to improve PD care in public and private health systems.

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

Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial.

Publications

Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial.

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