- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235595
Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea
Comparison of the Effects of High-frequency TENS and Connective Tissue Manipulation on the Primary Dysmenorrhea
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Connective Tissue Manipulation
The participants were administered CTM by a physiotherapist with 11 years of experience in the application from the point at which their menstrual cycles had ended to the beginning of the next cycle.
Another assessment was made immediately after the treatment and this was repeated at the second, third and fourth menstrual cycles.
The CTM took an average of 20-30 minutes to complete.
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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:
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Experimental: Transcutaneous Electrical Nerve Stimulation
Following the assessment made in the participants' first menstrual cycle, on the most painful day of their second cycle (1st or 2nd day of the cycle), high-frequency TENS was applied at a frequency of 120 Hertz, at intervals of 100 µsn for 20 minutes.
The intensity of the current was increased until the participant felt it.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Pain Severity
Time Frame: Change from Pain severity at 3 months
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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).
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Change from Pain severity at 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from Sleep Disorders and Fatigue severity at 3 months
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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.
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Change from Beck Depression Inventory score at 3 months
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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
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Change from Beck Anxiety Inventory score at 3 months
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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.
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Change from General Health Questionnaire score at 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nesrin Yağcı, Pamukkale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- primary dysmenorrhea ctm
- 2014SBE008 (Other Grant/Funding Number: Pamukkale University Scientific Research Projects)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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