Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Objectives
2.1.1. Main Objective
- To prove the Effectiveness of TTNS Treatment for PD in the Short, Medium, and Long Term
2.1.2. The Secondary Objectives Are
- To evaluate TTNS effectiveness in reducing NSAIDs in the short term.
- To evaluate TTNS effectiveness in reducing pain in the short term.
- To evaluate TTNS effectiveness in improving the quality of life of women with PD in the short term.
- To evaluate TTNS effectiveness in improving sleep deficiency among women with PD in the short term.
- To confirm if any decrease in pain is maintained over time.
- To confirm if any improvement in quality of life is maintained over time.
- To confirm if any improvement in sleep deficiency is maintained over time.
- To evaluate patient satisfaction with the treatment.
- To explore adverse reactions arising from the treatment.
2.2. Hypothesis
2.2.1. The General Hypothesis Is That
- The Application of TTNS Results in Decreased Pain during Menstruation, and An Improvement in Quality of Life and Sleep Deficiency
2.2.2. The Secondary Hypotheses Are That
- TTNS influences the nerve centers producing a modulation of reflex pathways, thus rebalancing the inhibitory and excitatory impulses that control painful uterine afferents.
- TTNS modulates A-delta and C-afferent fibers, which reduces pain sensation in the short-medium term and is maintained 6 months after treatment.
2.3. Design and Setting
2.4. Sample
2.5. Variables
2.5.1. Pain
- Maximum and mean pain intensity and pain duration: The visual analogue scale (VAS) will be used. It consists of a horizontal line of 10 cm: on the left is the absence or lesser intensity of pain, with 0: “no pain” and on the right the highest intensity, with 10: “the worst pain imaginable”. The patient will be asked to mark on the line the point that indicates the pain intensity that she feels. To know the score, the researcher will measure the distance from “no pain” to the patient’s mark [38,39,40]. The pain classification will be taken as mild pain (1–3 cm), moderate pain (4–6 cm) and severe pain (7–10 cm). The patient should fill in the scale each day of her menstruation indicating the maximum level of pain that she has experienced during each day.
- Pain severity: The McGill Short Questionnaire (SF-MPQ®) will be used. The questionnaire has three parts: the pain rating index; a sensory subscale with 15 items that are classified on an intensity scale where 0 = none, 1 = mild, 2 = moderate and 3 = strong, which ranges from 0 to 45 points; a VAS (ranged from 0 to 10); and the current pain index (a subscale that measures pain intensity from 0 to 5). The higher the SF-MPQ® score, the greater the pain severity [40,41]. The patient should fill in the questionnaire on the day of maximum pain of her menstruation.
- Number of anti-inflammatory drugs taken by the patients: a diary kept by the researcher will be used. The patients will record each NSAID in the diary, what type and amount of it they take during all the days of their menstruation and whether there has been pain relief with each dose.
2.5.2. Quality of Life
2.5.3. Sleep Quality
2.5.4. Overall Improvement and Treatment Satisfaction
- Patient’s Global Impression of Change Questionnaire (PGIC). The questionnaire consists of 7 items. The patient must choose the one that most closely approximates the improvement obtained with the treatment. The higher the score, the worse the impression of change [46]. The patient should fill it in at the end of the treatment and at the end of the reevaluation. Overall improvement will be measured at 5 months and at 11 months.
- As a subjective measure of the success of the treatment, patients will be asked, using a Likert scale, if they would like to continue with the treatment to maintain the objectives achieved. The scale shows the degree of agreement or disagreement with the treatment. The patient should fill it in at the end of the treatment and at the end of the reassessment. It will be measured at 5 and at 11 months.
2.5.5. Secondary Effects
2.6. Procedures and Timing
2.6.1. Arm 1, Experimental Group
2.6.2. Arm 2, Control Group
2.7. Data Collection and Management
2.8. Data Analysis
2.9. Ethical Considerations
3. Discussion
4. Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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Correyero-León, M.; Llamas-Ramos, R.; Calvo-Rodrigo, J.; Alvarado-Omenat, J.J.; Llamas-Ramos, I. Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial. Healthcare 2023, 11, 1633. https://doi.org/10.3390/healthcare11111633
Correyero-León M, Llamas-Ramos R, Calvo-Rodrigo J, Alvarado-Omenat JJ, Llamas-Ramos I. Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial. Healthcare. 2023; 11(11):1633. https://doi.org/10.3390/healthcare11111633
Chicago/Turabian StyleCorreyero-León, Marta, Rocío Llamas-Ramos, Javier Calvo-Rodrigo, Jorge Juan Alvarado-Omenat, and Inés Llamas-Ramos. 2023. "Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial" Healthcare 11, no. 11: 1633. https://doi.org/10.3390/healthcare11111633