Primary DysmenorrheaNCT04509934
The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea
A study testing Connective Tissue Manipulation in people with Primary Dysmenorrhea, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to reveal the effects of connective tissue manipulation (CTM) on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Connective Tissue Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2018to 30 Mar 2020
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Being in a age range 18-30
- Diagnosed with Primary Dysmenorrhea by a gynecologist
- Having a regular menstrual cycle (28±7 days)
- Being nulliparous
- Having menstrual pain intensity above 5cm according to Visual Analog Scale
Who cannot join
- Having gastrointestinal, urogynecologic, or psychiatric disease, other chronic pain syndromes
- Having a positive pregnancy test
- History of pelvic surgery
- Usage of oral contraceptives or antidepressants for at least 3 months
- Having irregular menstrual cycles (defined as lasting<21or>35 days)
- Having a history or an ultrasonographic observation of pathological conditions indicating secondary dysmenorrhea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea: Long-Term Follow-Up
The purpose of this study was to reveal the effects of connective tissue manipulation (CTM) on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms.
Read the detailed description
The purpose of this study was to reveal the effects of CTM on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms. The participants included to this study were randomised into two groups with simple randomisation method. CTM was performed to participants in both groups included the basic region (Sacral and lumbar), lower thoracic (between T12-T7) and anterior pelvic regions. In Group 1, starting at the end of the menstrual cycle, CTM was applied for 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period. Participants in the Group 2 CTM was started with the completion of menstrual cycle, 5 days a week and until the other menstrual cycles. At the end of the menstrual cycle, it was restarted and a total of 2 cycles were applied until the second menstrual cycle started (approximately 6 weeks). Both short and long strokes were used during manipulation. Each stroke was repeated for three times first on the right and then on the left side of all manipulated regions. All sessions were ended with bilateral long strokes to the iliac crest and subcostal regions. The treatment was started from the basic region and proceeded to other regions according to the vascular reaction of the connective tissue. Each session lasted 5 to 20 minutes, depending on the size of the treated region. During manipulation, the pad of the middle finger was in contact with the patient's skin. The finger was placed on the skin at 45° angle with distal interphalangeal joint in flexion and moved to cause traction. During back treatment, the participant was asked to sit erect, with hips, knees, and ankles at 90° flexion and thighs and feet are fully supported. During the treatment of anterior pelvic region, the patient was in a supine position with pillows placed under the head and knees. Treatment was performed by a trained physiotherapist. The participants' intensity of pain, fatigue and sleep quality were assessed with Visual Analogue Scale. Depressive symptoms and anxiety status, general health and premenstrual symptoms were assessed with Beck Depression Inventory, Beck Anxiety Inventory, General Health Questionnaire and Premenstrual Syndrome Scale, respectively. All measurements were repeated 5 times; baseline, after the first menstruation following the intervention period, 3th, 6th and 12th months after treatment.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Connective Tissue Manipulation
- Keywords
- primary dysmenorrhea, pain, women, connective tissue manipulation, longterm follow up
- 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
The position of the patients during treatment sessions was sitting with the hips and knees at 90° flexion and feet supported, arms relaxed on the thighs, back naked and straight, allowing optimal tension of the connective tissue. The CTM procedure consisted of treating 3 sections in the back. These sections were basic (sacral and lumbar regions), lower thoracic (L1 through T7) and anterior pelvic. All sessions were ended with bilateral long strokes to the iliac crest and subcostal regions. The physiotherapist applied strokes bilaterally by her middle finger of the right or left hand to the defined zones of the mentioned sections in the back. The treatment started from the basic section, and progress to other regions was decided according to the vascular reaction of the connective tissue. Each session lasted for 5 to 20 minutes, depending on the extent of the treated area.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Connective Tissue Manipulation was performed to participants in Group 1, starting at the end of the menstrual cycle, 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period. Receives: Other: Connective Tissue Manipulation |
| Group 2 | Active comparator | In Group 2, Connective Tissue Manipulation was started with the completion of menstrual cycle performed to participants for 5 days a week and until the other menstrual cycles. At the end of the menstrual cycle, it was restarted and a total of 2 cycles were applied until the second menstrual cycle started (approximately 6 weeks). Receives: Other: Connective Tissue Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Measured: baseline (first assessment) and 3th, 6th and 12th months after treatment
Visual Analogue Scale
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Measured: 3th month after treatment
Visual Analogue Scale
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Measured: 6th month after treatment
Visual Analogue Scale
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Measured: 12th month after treatment
Secondary outcomes (24)
Visual Analogue Scale
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Measured: baseline (first assessment)
Visual Analogue Scale
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Measured: 3th month after treatment
Visual Analogue Scale
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Measured: 6th month after treatment
Visual Analogue Scale
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Measured: 12th month after treatment
Visual Analogue Scale
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Measured: baseline (first assessment)
Visual Analogue Scale
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Measured: 3th month after treatment
Visual Analogue Scale
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Measured: 6th month after treatment
Visual Analogue Scale
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Measured: 12th month after treatment
Beck Depression Inventory
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Measured: baseline (first assessment)
Beck Depression Inventory
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Measured: 3th month after treatment
Beck Depression Inventory
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Measured: 6th month after treatment
Beck Depression Inventory
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Measured: 12th month after treatment
Beck Anxiety Inventory
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Measured: baseline (first assessment)
Beck Anxiety Inventory
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Measured: 3th month after treatment
Beck Anxiety Inventory
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Measured: 6th month after treatment
Beck Anxiety Inventory
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Measured: 12th month after treatment
General Health Questionnaire
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
Measured: baseline (first assessment)
General Health Questionnaire
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
Measured: 3th month after treatment
General Health Questionnaire
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
Measured: 6th month after treatment
General Health Questionnaire
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
Measured: 12th month after treatment
Premenstrual Syndrome Scale
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Measured: baseline (first assessment)
Premenstrual Syndrome Scale
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Measured: 3th month after treatment
Premenstrual Syndrome Scale
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Measured: 6th month after treatment
Premenstrual Syndrome Scale
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Measured: 12th month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start30 Jul 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Aybike Senel, Istanbul University - Cerrahpasa
- Investigators
- Nesrin Yağcı, PT, Prof, Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509934
- Sponsor's protocol ID
- 12
- Status last verified
- Aug 2020
- First submitted
- 14 Jul 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yagci N, Senel A, Atalay OT, Akman TC, Can OK. Long-Term Follow-Up Result of Connective Tissue Manipulation in Young Women with Primary Dysmenorrhea: Different Intervention Durations. Reprod Sci. 2023 Jul;30(7):2198-2209. doi: 10.1007/s43032-023-01172-5. Epub 2023 Jan 30.
PubMed 36717461
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea: Long-Term Follow-Up
- ClinicalTrials.gov ID
- NCT04509934
- Acronym / sponsor ID
- 12
- Conditions
- Primary Dysmenorrhea
- Keywords
- primary dysmenorrhea, pain, women, connective tissue manipulation, longterm follow up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 12 Aug 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.
The purpose of this study was to reveal the effects of connective tissue manipulation (CTM) on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms.
Detailed description
The purpose of this study was to reveal the effects of CTM on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms. The participants included to this study were randomised into two groups with simple randomisation method. CTM was performed to participants in both groups included the basic region (Sacral and lumbar), lower thoracic (between T12-T7) and anterior pelvic regions. In Group 1, starting at the end of the menstrual cycle, CTM was applied for 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period. Participants in the Group 2 CTM was started with the completion of menstrual cycle, 5 days a week and until the other menstrual cycles. At the end of the menstrual cycle, it was restarted and a total of 2 cycles were applied until the second menstrual cycle started (approximately 6 weeks). Both short and long strokes were used during manipulation. Each stroke was repeated for three times first on the right and then on the left side of all manipulated regions. All sessions were ended with bilateral long strokes to the iliac crest and subcostal regions. The treatment was started from the basic region and proceeded to other regions according to the vascular reaction of the connective tissue. Each session lasted 5 to 20 minutes, depending on the size of the treated region. During manipulation, the pad of the middle finger was in contact with the patient's skin. The finger was placed on the skin at 45° angle with distal interphalangeal joint in flexion and moved to cause traction. During back treatment, the participant was asked to sit erect, with hips, knees, and ankles at 90° flexion and thighs and feet are fully supported. During the treatment of anterior pelvic region, the patient was in a supine position with pillows placed under the head and knees. Treatment was performed by a trained physiotherapist. The participants' intensity of pain, fatigue and sleep quality were assessed with Visual Analogue Scale. Depressive symptoms and anxiety status, general health and premenstrual symptoms were assessed with Beck Depression Inventory, Beck Anxiety Inventory, General Health Questionnaire and Premenstrual Syndrome Scale, respectively. All measurements were repeated 5 times; baseline, after the first menstruation following the intervention period, 3th, 6th and 12th months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Connective Tissue ManipulationConnective Tissue Manipulation was performed to participants in Group 1, starting at the end of the menstrual cycle, 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period. |
| Group 2 | Active comparator | Other: Connective Tissue ManipulationIn Group 2, Connective Tissue Manipulation was started with the completion of menstrual cycle performed to participants for 5 days a week and until the other menstrual cycles. At the end of the menstrual cycle, it was restarted and a total of 2 cycles were applied until the second menstrual cycle started (approximately 6 weeks). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being in a age range 18-30
- Diagnosed with Primary Dysmenorrhea by a gynecologist
- Having a regular menstrual cycle (28±7 days)
- Being nulliparous
- Having menstrual pain intensity above 5cm according to Visual Analog Scale
Key exclusion criteria (6 listed)
- Having gastrointestinal, urogynecologic, or psychiatric disease, other chronic pain syndromes
- Having a positive pregnancy test
- History of pelvic surgery
- Usage of oral contraceptives or antidepressants for at least 3 months
- Having irregular menstrual cycles (defined as lasting<21or>35 days)
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 ManipulationThe position of the patients during treatment sessions was sitting with the hips and knees at 90° flexion and feet supported, arms relaxed on the thighs, back naked and straight, allowing optimal tension of the connective tissue. The CTM procedure consisted of treating 3 sections in the back. These sections were basic (sacral and lumbar regions), lower thoracic (L1 through T7) and anterior pelvic. All sessions were ended with bilateral long strokes to the iliac crest and subcostal regions. The physiotherapist applied strokes bilaterally by her middle finger of the right or left hand to the defined zones of the mentioned sections in the back. The treatment started from the basic section, and progress to other regions was decided according to the vascular reaction of the connective tissue. Each session lasted for 5 to 20 minutes, depending on the extent of the treated area. | Other | Group 1, Group 2 |
Primary outcome
Visual Analogue Scale
Time frame: baseline (first assessment) and 3th, 6th and 12th months after treatment
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Visual Analogue Scale
Time frame: 3th month after treatment
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Visual Analogue Scale
Time frame: 6th month after treatment
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Visual Analogue Scale
Time frame: 12th month after treatment
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
24 secondary outcomes
Visual Analogue Scale
Time frame: baseline (first assessment)
Visual Analogue Scale
Time frame: 3th month after treatment
Visual Analogue Scale
Time frame: 6th month after treatment
Visual Analogue Scale
Time frame: 12th month after treatment
Visual Analogue Scale
Time frame: baseline (first assessment)
Visual Analogue Scale
Time frame: 3th month after treatment
Visual Analogue Scale
Time frame: 6th month after treatment
Visual Analogue Scale
Time frame: 12th month after treatment
Beck Depression Inventory
Time frame: baseline (first assessment)
Beck Depression Inventory
Time frame: 3th month after treatment
Beck Depression Inventory
Time frame: 6th month after treatment
Beck Depression Inventory
Time frame: 12th month after treatment
Beck Anxiety Inventory
Time frame: baseline (first assessment)
Beck Anxiety Inventory
Time frame: 3th month after treatment
Beck Anxiety Inventory
Time frame: 6th month after treatment
Beck Anxiety Inventory
Time frame: 12th month after treatment
General Health Questionnaire
Time frame: baseline (first assessment)
General Health Questionnaire
Time frame: 3th month after treatment
General Health Questionnaire
Time frame: 6th month after treatment
General Health Questionnaire
Time frame: 12th month after treatment
Premenstrual Syndrome Scale
Time frame: baseline (first assessment)
Premenstrual Syndrome Scale
Time frame: 3th month after treatment
Premenstrual Syndrome Scale
Time frame: 6th month after treatment
Premenstrual Syndrome Scale
Time frame: 12th month after treatment
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 12 Aug 2020.
- Derived from this study: PubMed 36717461Yagci N, Senel A, Atalay OT, Akman TC, Can OK. Long-Term Follow-Up Result of Connective Tissue Manipulation in Young Women with Primary Dysmenorrhea: Different Intervention Durations. Reprod Sci. 2023 Jul;30(7):2198-2209. doi: 10.1007/s43032-023-01172-5. Epub 2023 Jan 30.
- 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, PT, Prof study chair
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective Tissue Manipulation in people with Primary Dysmenorrhea, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Visual Analogue Scale (time frame: baseline (first assessment) and 3th, 6th and 12th months after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509934, which also lists 1 linked publication.
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 12 Aug 2020.