The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea

August 11, 2020 updated by: Aybike Senel, Istanbul University - Cerrahpasa (IUC)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20000
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1
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.
Other: Connective Tissue Manipulation
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.
Active Comparator: Group 2
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).
Other: Connective Tissue Manipulation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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."
baseline (first assessment) and 3th, 6th and 12th months after treatment
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."
3th month after treatment
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."
6th month after treatment
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."
12th month after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: baseline (first assessment)
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."
baseline (first assessment)
Visual Analogue Scale
Time Frame: 3th month after treatment
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."
3th month after treatment
Visual Analogue Scale
Time Frame: 6th month after treatment
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."
6th month after treatment
Visual Analogue Scale
Time Frame: 12th month after treatment
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."
12th month after treatment
Visual Analogue Scale
Time Frame: baseline (first assessment)
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.
baseline (first assessment)
Visual Analogue Scale
Time Frame: 3th month after treatment
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.
3th month after treatment
Visual Analogue Scale
Time Frame: 6th month after treatment
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.
6th month after treatment
Visual Analogue Scale
Time Frame: 12th month after treatment
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.
12th month after treatment
Beck Depression Inventory
Time Frame: baseline (first assessment)
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
baseline (first assessment)
Beck Depression Inventory
Time Frame: 3th month after treatment
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
3th month after treatment
Beck Depression Inventory
Time Frame: 6th month after treatment
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
6th month after treatment
Beck Depression Inventory
Time Frame: 12th month after treatment
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
12th month after treatment
Beck Anxiety Inventory
Time Frame: baseline (first assessment)
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.
baseline (first assessment)
Beck Anxiety Inventory
Time Frame: 3th month after treatment
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.
3th month after treatment
Beck Anxiety Inventory
Time Frame: 6th month after treatment
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.
6th month after treatment
Beck Anxiety Inventory
Time Frame: 12th month after treatment
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.
12th month after treatment
General Health Questionnaire
Time Frame: baseline (first assessment)
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.
baseline (first assessment)
General Health Questionnaire
Time Frame: 3th month after treatment
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.
3th month after treatment
General Health Questionnaire
Time Frame: 6th month after treatment
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.
6th month after treatment
General Health Questionnaire
Time Frame: 12th month after treatment
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.
12th month after treatment
Premenstrual Syndrome Scale
Time Frame: baseline (first assessment)
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.
baseline (first assessment)
Premenstrual Syndrome Scale
Time Frame: 3th month after treatment
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.
3th month after treatment
Premenstrual Syndrome Scale
Time Frame: 6th month after treatment
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.
6th month after treatment
Premenstrual Syndrome Scale
Time Frame: 12th month after treatment
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.
12th month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pamukkale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nesrin Yağcı, PT, Prof, Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12 (Israel lung Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Conditions

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