Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235595
• Other study ID #: primary dysmenorrhea ctm
• Secondary ID: 2014SBE008
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: August 30, 2016

Study information

• Verified date: January 2020
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2016
• Est. primary completion date: March 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Other:
• Connective Tissue Manipulation
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.
• Transcutaneous Electrical Nerve Stimulation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Bakircay University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Pain Severity	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).	Change from Pain severity at 3 months
Secondary	Assessment of Sleep Disorders and Fatigue	A 10cm VAS was used to assess the severity of sleep disorder and fatigue in the cases of dysmenorrhea.	Change from Sleep Disorders and Fatigue severity at 3 months
Secondary	Assessment of Depressive Symptoms	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.	Change from Beck Depression Inventory score at 3 months
Secondary	Assessment of Anxiety	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	Change from Beck Anxiety Inventory score at 3 months
Secondary	Assessment of General Health Status	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.	Change from General Health Questionnaire score at 3 months