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Completed

NCT Number: NCT04235595

Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea

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.

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Key information

Conditions

Primary Dysmenorrhea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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,

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Connective Tissue Manipulation

Other

The application was delivered with the participant in a sitting position, with the entire back and sacral regions left exposed. The treatment was administered to the sacral, lower thoracic and pelvic regions.

Other names: CTM

Transcutaneous Electrical Nerve Stimulation

Other

TENS was administered with the participant lying face down with a flat cushion underneath the abdomen. TENS was administered via 2 channels of electrodes placed with the sacral region in the middle. The intensity of the current was increased until the participant felt it.

Other names: TENS

Primary outcomes

  1. Assessment of Pain Severity

    Time frame: 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 outcomes

  1. Assessment of Sleep Disorders and Fatigue

    Time frame: 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.

  2. Assessment of Depressive Symptoms

    Time frame: 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.

  3. Assessment of Anxiety

    Time frame: 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

  4. Assessment of General Health Status

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

Comparison of the Effects of High-frequency TENS and Connective Tissue Manipulation on the Primary Dysmenorrhea

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 22, 2020
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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