Back to resultsComparison of the Effects of TENS and CTM on Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Connective Tissue Manipulation
Transcutaneous Electrical Nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Primary dysmenorrhea, Connective tissue manipulation (CTM), Transcutaneous electrical nerve stimulation (TENS), Pain
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Connective Tissue Manipulation
Transcutaneous Electrical Nerve Stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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
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.
Full Information
NCT ID
NCT04235595
First Posted
January 13, 2020
Last Updated
January 16, 2020
Sponsor
Izmir Bakircay University
1. Study Identification
Unique Protocol Identification Number
NCT04235595
Brief Title
Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea
Official Title
Comparison of the Effects of High-frequency TENS and Connective Tissue Manipulation on the Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
March 15, 2016 (Actual)
Study Completion Date
August 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Primary dysmenorrhea, Connective tissue manipulation (CTM), Transcutaneous electrical nerve stimulation (TENS), Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Connective Tissue Manipulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Transcutaneous Electrical Nerve Stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Connective Tissue Manipulation
Other Intervention Name(s)
CTM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Other Intervention Name(s)
TENS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Pain Severity
Description
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).
Time Frame
Change from Pain severity at 3 months
Secondary Outcome Measure Information:
Title
Assessment of Sleep Disorders and Fatigue
Description
A 10cm VAS was used to assess the severity of sleep disorder and fatigue in the cases of dysmenorrhea.
Time Frame
Change from Sleep Disorders and Fatigue severity at 3 months
Title
Assessment of Depressive Symptoms
Description
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.
Time Frame
Change from Beck Depression Inventory score at 3 months
Title
Assessment of Anxiety
Description
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
Time Frame
Change from Beck Anxiety Inventory score at 3 months
Title
Assessment of General Health Status
Description
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.
Time Frame
Change from General Health Questionnaire score at 3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Menstrual cycle
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesrin Yağcı
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea
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