Pelvic PainNCT04910672
Primary Dysmenorrhea and Osteopathic Treatment
A study testing Experimental Group in people with Pelvic Pain and Pelvic Pain Syndrome, run by Escuela de osteopatía de Madrid at 1 site in Spain.
Trial summary
This study is adressed to women with primary dysmenorrhea, it´s a gynecological disorder that is defined as colicky pain associated with menstruation and is located in the lower abdomen and in the lumbo-pelvic area. 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
- Pelvic Pain, Pelvic Pain Syndrome, Sexual Dysfunction
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2021to Nov 2021
- 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
- Crampy pain in the lower abdomen or lumbo-pelvic area between 8 hours and 4 days after menstrual bleeding.
- Clinical evolution of at least three menstrual cycles with said pathology.
- Moderate menstrual pain or severe intensity, minimum 5 VAS scale.
- Regular menstrual cycle, between 21 and 35 days.
- Accept informed consent.
Who cannot join
- Being receiving any other physiotherapeutic or pharmacological treatment for primary dysmenorrhea during the 3 weeks prior to the beginning of the intervention.
- Suffering from cardiovascular diseases, prolapse, amenorrhea, hemophilia, tumor or infectious processes, use of IUDs, consumption of oral contraceptives or suffering from any injury that affects the sensory-motor function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Osteopathic Treatment in Patients With Primary Dysmenorrhea
This study is adressed to women with primary dysmenorrhea, it´s a gynecological disorder that is defined as colicky pain associated with menstruation and is located in the lower abdomen and in the lumbo-pelvic area. It appears between the first 8-72 hours and four days of the menstrual cycle and affects almost 85% of women, 30% of them severely. This study aims to demonstrate that osteopathic manual therapy is an effective therapeutic option in patients with primary dysmenorrhea. Another objective is to verify that osteopathic manual treatment provides an improvement in the intensity of pain, quality of life and a reduction in the consumption of medicines in these patients.
Read the detailed description
It will be a prospective study, a double-blind randomized controlled clinical trial. The sample group will include 60 patients, between 18 and 30 years old divided into two experimental groups. The experimental group (n = 30) will be treated following an osteopathic treatment, through a bilateral global pelvic manupulation (GPM) and a specific internal technique for mobility of the cervix, and the control group (n = 30) will only carry out a bilateral GPM. A measurement will be made before the first treatment, another after each session, and the last one two weeks after the last intervention (anthropometric measurements, quality of life questionnaire, sexual health, osteopathic tests, pressure point with algometer, pain and medicines consumption). The established outcome measures are: pain intensity according to the visual analog scale (VAS), depression points measured with an algometer, a health-related quality of life questionnaire, questionnaire sexual health and sexual dysfunctions, and the measurement of drug consumption.
- Conditions
- Pelvic Pain, Pelvic Pain Syndrome, Sexual Dysfunction
- Being tested
- Control Group, Experimental Group
- Keywords
- Primary Dysmenorrhea, Spinal Manipulation, Pelvic Pain, Pain Threshold, Sexual Dysfunctions, Osteopathic Treatment, Manual therapy, Visceral Manipulation
- Medical subject headings
- Pelvic Pain, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Bilateral global pelvic manipulation. Lower right limb in extension. The left lower limb in flexion, until the tension on the SPIS was felt. Introduce very little rotation of the spine. ASI anterior slide until crease forms at waist.
We bring the elbow towards our hips. We rotate the patient posteriorly to open the lumbo sacral facet. The thrust is performed by simultaneously increasing these three parameters, with kick and joint compression.
Experimental GroupOther
Bilateral Global Pelvic Manipulation and Internal Correction Technique for Laterflexion of the Uterus The technique consists of making contact with the vaginal fingers on the upper and anterior part of the cervix, while the abdominal hand, dragging the skin towards the pubis, tries to make contact as posterior as possible on the fundus of the uterus. The technique consists, while the patient breathes widely, in progressively raising the uterine fundus forward and upward and lowering the cervix until the normal anteversion position is achieved.
At the end of the technique, fixing the correction position of the uterus, we can ask the patient to perform a pelvic anteversion, while the correction is maintained. At the end of the technique, all abnormal tension should have disappeared and the uterus should have recovered a physiological position of anteversion.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group (n = 30) will only carry out a bilateral global pelvic manipulation Receives: Other: Control Group |
| Experimental Group | Experimental | The experimental group (n = 30) will be treated following an osteopathic treatment, through a bilateral global pelvic manipulation and a specific internal technique for mobility of the cervix Receives: Other: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Visual Analogue Scale (pain) during menstruation at week 4, 8 and 10.
Measured before the treatment in each meeting, asking about the pain during the last menstrual period. The higher is the value of the scale, the worse.
Measured: Baseline and week 4, 8 and 10
Change from Baseline in the Specific Quality of Life Questionnaire Related to Menstruation CVM-22 at weeks 4, 8 and 10
The CVM-22, self-administered Likert type, is made up of 22 items. The questionnaire score ranges from 0 to 66, where the higher the score the worse the CVM-22.
Measured: Baseline and weeks 4, 8 and 10
Change from Baseline in the Questionnaire on sexual health and detection of female sexual dysfunctions in primary care (SyDSF-AP) at weeks 4, 8 and 10
Self-administered questionnaire of 20 closed questions, although 8, 9 and 19 have an open component, and 1 is an open question, which is integrated into domains. Those of the descriptive sociodemographic domain and the health condition help to know the profile of the surveyed women, as well as the factors that may influence their sexuality. The domain of sexual function ranges from question 10 to 18 and is answered using a Likert scale of 5 values. In addition, question 20 has been included to assess satisfaction with your partner from 0 to 10. Finally, question 21 is open to collect the comments that may arise during the completion of the questionnaire.
Measured: Baseline and weeks 4, 8 and 10
change from baseline in the values of the pressure algometer measured on 9 different points at weeks 4, 8 and 10.
The Pressure Threshold is defined as the minimum pressure that triggers a painful response. The WAGNER brand "FORCE TEN" pressure algometer was used to quantify the Pressure Thereshold at the 9 sensitive pressure points of dysmenorrhea. The rubber tip was used to focus the pressure exerted by the evaluator and it was placed perpendicular to each point. The measurements were carried out 3 times for each point (with 10 seconds of difference between each measurement, 30 before moving on to another point) and calculating the mean value. Before carrying out the measurements, the patients were instructed in the procedure, giving as an example an area not included in the assessment. When the pressure sensation started to be painful, they should tell the evaluator.
Measured: Pre-intervention and post-intervention in Baseline and weeks 4 and 8. Another measure without intervention in week 10.
Change from baseline in Medication intake during the menstrual period at weeks 4, 8 and 10.
The average consumption of NSAIDs by the dose of medication used, self-reported responses by the participants. It will be recorded in a journal that will be given to them to write down.
Measured: Baseline and weeks 4, 8 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study startJul 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies 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
- Model description
- This is a double-blind prospective, longitudinal, randomized, controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escuela de osteopatía de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- University of Seville
- Responsible party
- Principal investigator, Sara Santiago Tello, Escuela de osteopatía de Madrid
- Investigators
- François Ricard, DO, Study director, Escuela Osteopatía Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910672
- Sponsor's protocol ID
- OsteopatiaMadrid
- Other IDs
- MCLozano
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Osteopathic Treatment in Patients With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT04910672
- Acronym / sponsor ID
- OsteopatiaMadrid
- Conditions
- Pelvic Pain, Pelvic Pain Syndrome, Sexual Dysfunction
- Keywords
- Primary Dysmenorrhea, Spinal Manipulation, Pelvic Pain, Pain Threshold, Sexual Dysfunctions, Osteopathic Treatment, Manual therapy, Visceral Manipulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Escuela de osteopatía de MadridUniversity, hospital or other
- Collaborators
- University of Seville
- Study start
- Jul 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 2 Jun 2021 (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 is adressed to women with primary dysmenorrhea, it´s a gynecological disorder that is defined as colicky pain associated with menstruation and is located in the lower abdomen and in the lumbo-pelvic area. It appears between the first 8-72 hours and four days of the menstrual cycle and affects almost 85% of women, 30% of them severely. This study aims to demonstrate that osteopathic manual therapy is an effective therapeutic option in patients with primary dysmenorrhea. Another objective is to verify that osteopathic manual treatment provides an improvement in the intensity of pain, quality of life and a reduction in the consumption of medicines in these patients.
Detailed description
It will be a prospective study, a double-blind randomized controlled clinical trial. The sample group will include 60 patients, between 18 and 30 years old divided into two experimental groups. The experimental group (n = 30) will be treated following an osteopathic treatment, through a bilateral global pelvic manupulation (GPM) and a specific internal technique for mobility of the cervix, and the control group (n = 30) will only carry out a bilateral GPM. A measurement will be made before the first treatment, another after each session, and the last one two weeks after the last intervention (anthropometric measurements, quality of life questionnaire, sexual health, osteopathic tests, pressure point with algometer, pain and medicines consumption). The established outcome measures are: pain intensity according to the visual analog scale (VAS), depression points measured with an algometer, a health-related quality of life questionnaire, questionnaire sexual health and sexual dysfunctions, and the measurement of drug consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blind prospective, longitudinal, randomized, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control GroupThe control group (n = 30) will only carry out a bilateral global pelvic manipulation |
| Experimental Group | Experimental | Other: Experimental GroupThe experimental group (n = 30) will be treated following an osteopathic treatment, through a bilateral global pelvic manipulation and a specific internal technique for mobility of the cervix |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Crampy pain in the lower abdomen or lumbo-pelvic area between 8 hours and 4 days after menstrual bleeding.
- Clinical evolution of at least three menstrual cycles with said pathology.
- Moderate menstrual pain or severe intensity, minimum 5 VAS scale.
- Regular menstrual cycle, between 21 and 35 days.
- Accept informed consent.
Key exclusion criteria (2 listed)
- Being receiving any other physiotherapeutic or pharmacological treatment for primary dysmenorrhea during the 3 weeks prior to the beginning of the intervention.
- Suffering from cardiovascular diseases, prolapse, amenorrhea, hemophilia, tumor or infectious processes, use of IUDs, consumption of oral contraceptives or suffering from any injury that affects the sensory-motor function.
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 |
|---|---|---|
| Control GroupBilateral global pelvic manipulation. Lower right limb in extension. The left lower limb in flexion, until the tension on the SPIS was felt. Introduce very little rotation of the spine. ASI anterior slide until crease forms at waist. We bring the elbow towards our hips. We rotate the patient posteriorly to open the lumbo sacral facet. The thrust is performed by simultaneously increasing these three parameters, with kick and joint compression. | Other | Control Group |
| Experimental GroupBilateral Global Pelvic Manipulation and Internal Correction Technique for Laterflexion of the Uterus The technique consists of making contact with the vaginal fingers on the upper and anterior part of the cervix, while the abdominal hand, dragging the skin towards the pubis, tries to make contact as posterior as possible on the fundus of the uterus. The technique consists, while the patient breathes widely, in progressively raising the uterine fundus forward and upward and lowering the cervix until the normal anteversion position is achieved. At the end of the technique, fixing the correction position of the uterus, we can ask the patient to perform a pelvic anteversion, while the correction is maintained. At the end of the technique, all abnormal tension should have disappeared and the uterus should have recovered a physiological position of anteversion. | Other | Experimental Group |
Primary outcome
Change from Baseline in the Visual Analogue Scale (pain) during menstruation at week 4, 8 and 10.
Time frame: Baseline and week 4, 8 and 10
Measured before the treatment in each meeting, asking about the pain during the last menstrual period. The higher is the value of the scale, the worse.
Change from Baseline in the Specific Quality of Life Questionnaire Related to Menstruation CVM-22 at weeks 4, 8 and 10
Time frame: Baseline and weeks 4, 8 and 10
The CVM-22, self-administered Likert type, is made up of 22 items. The questionnaire score ranges from 0 to 66, where the higher the score the worse the CVM-22.
Change from Baseline in the Questionnaire on sexual health and detection of female sexual dysfunctions in primary care (SyDSF-AP) at weeks 4, 8 and 10
Time frame: Baseline and weeks 4, 8 and 10
Self-administered questionnaire of 20 closed questions, although 8, 9 and 19 have an open component, and 1 is an open question, which is integrated into domains. Those of the descriptive sociodemographic domain and the health condition help to know the profile of the surveyed women, as well as the factors that may influence their sexuality. The domain of sexual function ranges from question 10 to 18 and is answered using a Likert scale of 5 values. In addition, question 20 has been included to assess satisfaction with your partner from 0 to 10. Finally, question 21 is open to collect the comments that may arise during the completion of the questionnaire.
change from baseline in the values of the pressure algometer measured on 9 different points at weeks 4, 8 and 10.
Time frame: Pre-intervention and post-intervention in Baseline and weeks 4 and 8. Another measure without intervention in week 10.
The Pressure Threshold is defined as the minimum pressure that triggers a painful response. The WAGNER brand "FORCE TEN" pressure algometer was used to quantify the Pressure Thereshold at the 9 sensitive pressure points of dysmenorrhea. The rubber tip was used to focus the pressure exerted by the evaluator and it was placed perpendicular to each point. The measurements were carried out 3 times for each point (with 10 seconds of difference between each measurement, 30 before moving on to another point) and calculating the mean value. Before carrying out the measurements, the patients were instructed in the procedure, giving as an example an area not included in the assessment. When the pressure sensation started to be painful, they should tell the evaluator.
Change from baseline in Medication intake during the menstrual period at weeks 4, 8 and 10.
Time frame: Baseline and weeks 4, 8 and 10
The average consumption of NSAIDs by the dose of medication used, self-reported responses by the participants. It will be recorded in a journal that will be given to them to write down.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
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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.
François Ricard, DO study director
Escuela Osteopatía Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Pelvic Pain and Pelvic Pain Syndrome, run by Escuela de osteopatía de Madrid at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara S Tello, PT (651458007, sara_santiago_tello@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Visual Analogue Scale (pain) during menstruation at week 4, 8 and 10. (time frame: Baseline and week 4, 8 and 10). The study lists 5 primary outcomes in all. 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 2 Jun 2021.