Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea

• Registration Number: NCT04235595
• Lead Sponsor: Izmir Bakircay University

Brief Summary

this study was to compare the early and short-term effects of high-frequency transcutaneous electrical nerve stimulation (TENS) versus connective tissue manipulation (CTM) in participants with primary dysmenorrhea. Half of the participants received CTM, while the other half received TENS.

Detailed Description

CTM and TENS each relieve dysmenorrhea pain, but they do so by different. The electrotherapy modality that is most commonly used in the treatment of dysmenorrhea is TENS. It has been reported in studies that high-frequency TENS is more effective in reducing pain than either low-frequency TENS or placebo TENS.

A scan of the literature reveals that although there are differing opinions and applications related to the number and duration of CTM, it has been shown that women with primary dysmenorrhea experience reduced pain after CTM,

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-03-15
• Study Completion: 2016-08-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-16
• Last Update Submitted: 2020-01-16
• Study First Posted: 2020-01-22
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• being between the ages of 18-30
• having a diagnosis of primary dysmenorrhea

Exclusion Criteria

• having used an oral contraceptive in the last 3 months,
• having an active sexual life,
• pregnancy,
• having gone through childbirth,
• having a neurological deficit,
• any kind of systemic condition,
• a diagnosed gynecological condition (pelvic inflammatory diseases, endometriosis, uterus cancers, ovarian cysts, etc.),
• taking psychotherapeutic drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of Pain Severity	Change from Pain severity at 3 months	To determine the localization of pain, the participants were asked to point out and mark the place(s) they felt the most pain on a body diagram. The severity of the pain of dysmenorrhea was assessed on a 10-cm Visual Analog Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Assessment of Depressive Symptoms	Change from Beck Depression Inventory score at 3 months	The Turkish version of the Beck Depression Inventory (BDI) was used in order to identify the risk participants faced in terms of depression and the level of their depressive symptoms. The inventory contains 21 categories, each having 4 choices to mark. The items score between 0-3. The total possible score is 0-63. A score of 0-9 is defined as relating to depressive symptoms at a minimal level, a score of 10-16 to slight depressive symptoms, 17-29 to moderate depressive symptoms, 30-63 to severe depressive symptoms.
Assessment of Sleep Disorders and Fatigue	Change from Sleep Disorders and Fatigue severity at 3 months	A 10cm VAS was used to assess the severity of sleep disorder and fatigue in the cases of dysmenorrhea.
Assessment of Anxiety	Change from Beck Anxiety Inventory score at 3 months	The Turkish version of the Beck Anxiety Inventory (BAI) was used to assess anxiety. This inventory consists of 21 categories, each item being scored on a scale of 0-3. The total possible score on the inventory is 0-63. A score of 0-17 is defined as indicating low, 18-24 as indicating moderate, and a score of 25 and over as indicating a high level of anxiety
Assessment of General Health Status	Change from General Health Questionnaire score at 3 months	The "General Health Questionnaire" (GHA-28) was used in order to learn the general health status of the participants during their menstrual cycles. The 28-item questionnaire we used in the study assesses the psychological symptoms experienced in the last week. The questionnaire contains four sub-divisions of seven items each. The minimum score on the scale is 0; maximum is 84. Higher scores indicate a state of poor health.