Primary DysmenorrheaNCT04235595
Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea
A study testing Connective Tissue Manipulation and Transcutaneous Electrical Nerve Stimulation in people with Primary Dysmenorrhea, run by Izmir Bakircay University.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Connective Tissue Manipulation and Transcutaneous Electrical Nerve Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 30 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being between the ages of 18-30
- having a diagnosis of primary dysmenorrhea
Who cannot join
- 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.
About this study
Official title: Comparison of the Effects of High-frequency TENS and Connective Tissue Manipulation on the 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.
Read the 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,
- Conditions
- Primary Dysmenorrhea
- Being tested
- Connective Tissue Manipulation, Transcutaneous Electrical Nerve Stimulation
- Keywords
- Primary dysmenorrhea, Connective tissue manipulation (CTM), Transcutaneous electrical nerve stimulation (TENS), Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue ManipulationOther
Also called CTM
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 StimulationOther
Also called TENS
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.
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Manipulation | Experimental | 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. Receives: Other: Connective Tissue Manipulation |
| Transcutaneous Electrical Nerve Stimulation | Experimental | 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. Receives: Other: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Pain severity at 3 months
Secondary outcomes (4)
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.
Measured: Change from Sleep Disorders and Fatigue severity at 3 months
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.
Measured: Change from Beck Depression Inventory score at 3 months
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
Measured: Change from Beck Anxiety Inventory score at 3 months
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.
Measured: Change from General Health Questionnaire score at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Sep 2015
- Primary completion15 Mar 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Yürekdeler Şahin, Izmir Bakircay University
- Investigators
- Nesrin Yağcı, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235595
- Sponsor's protocol ID
- primary dysmenorrhea ctm
- Other IDs
- 2014SBE008
- Status last verified
- Jan 2020
- First submitted
- 13 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of High-frequency TENS and Connective Tissue Manipulation on the Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT04235595
- Acronym / sponsor ID
- primary dysmenorrhea ctm
- Conditions
- Primary Dysmenorrhea
- Keywords
- Primary dysmenorrhea, Connective tissue manipulation (CTM), Transcutaneous electrical nerve stimulation (TENS), Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 15 Mar 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Manipulation | Experimental | Other: Connective Tissue ManipulationThe 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. |
| Transcutaneous Electrical Nerve Stimulation | Experimental | Other: Transcutaneous Electrical Nerve StimulationFollowing 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- being between the ages of 18-30
- having a diagnosis of primary dysmenorrhea
Key exclusion criteria (8 listed)
- having used an oral contraceptive in the last 3 months,
- having an active sexual life,
- pregnancy,
- having gone through childbirth,
- having a neurological deficit,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connective Tissue ManipulationAlso: CTMThe 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 | Connective Tissue Manipulation |
| Transcutaneous Electrical Nerve StimulationAlso: TENSTENS 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 | Transcutaneous Electrical Nerve Stimulation |
Primary outcome
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).
4 secondary outcomes
Assessment of Sleep Disorders and Fatigue
Time frame: Change from Sleep Disorders and Fatigue severity at 3 months
Assessment of Depressive Symptoms
Time frame: Change from Beck Depression Inventory score at 3 months
Assessment of Anxiety
Time frame: Change from Beck Anxiety Inventory score at 3 months
Assessment of General Health Status
Time frame: Change from General Health Questionnaire score at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nesrin Yağcı study director
Pamukkale University
Questions about this trial
What is this clinical trial studying?
A study testing Connective Tissue Manipulation and Transcutaneous Electrical Nerve Stimulation in people with Primary Dysmenorrhea, run by Izmir Bakircay University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pain Severity (time frame: Change from Pain severity at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.