Dysmenorrhea PrimaryMTDysmenNCT03593057
Effectiveness of Manual Therapy in Dysmenorrhea
A study testing Manual therapy in people with Dysmenorrhea Primary, run by University of Valencia at 2 sites in Spain.
Trial summary
The objective of this clinical study would be to verify if manual therapy is effective in the treatment to reduce pain in women suffering from primary dysmenorrhea. Material and methods In this experimental study, women diagnosed with primary dysmenorrhea will be included, which will be divided randomly into two… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Jun 2018to 31 Aug 2018
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with menstrual pain of more than 6 months of evolution.
- Women with pain equal to or greater than 4 on the visual analogue scale in more than half of their one-year menstrual cycles.
Who cannot join
- Hormone treatment
- Contraindication to any of the treatments
- Participate in this period of no functional recovery program or physiotherapy treatment.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Faculty of Physiotherapy
Valencia, 46010
Gemma V Espí López
Valencia, 46010
About this study
Official title: Effectiveness of a Manual Therapy Protocol in Women With Dysmenorrhea
The objective of this clinical study would be to verify if manual therapy is effective in the treatment to reduce pain in women suffering from primary dysmenorrhea.
Material and methods In this experimental study, women diagnosed with primary dysmenorrhea will be included, which will be divided randomly into two groups: an intervention group and a comparator group.
The study will last nine weeks (3 menstrual cycles). Patients in the intervention group will receive 3 treatment sessions.
The evaluation will include pain, the quality of life, the global impression of change, personal body satisfaction and global self-perception and the pain perception.
Read the detailed description
Introduction The prevalence of primary dysmenorrhoea is high and has an impact on quality of life, pain and disability. The cause is due to the increase of postaglandins that can be influenced by the lowering of progesterone. In short, there is a complex relationship between hormones and the immune system.
Manual therapy increases the mobility of the sacrum and tissues of the pelvis, increasing the blood supply and the uterus that has parasympathetic innervation through the sacrum improves mobility, motility and irrigation.
The ligaments, fasciae and tissue of the pelvis improve their irrigation through fascial, mobility and visceral techniques, which would improve uterine mobility by anatomical connections with these structures. With better mobility the uterus, and therefore the smooth muscle, would have more irrigation and less pain and hypercontractivility.
The adjacent tissues, perineum, triangular ligament, innervated by the vagus nerve, improve
The main objective is the improvement of quality of life, personal body satisfaction and overall self-perception and pain reduction in women with dysmenorrhea after treatment with manual therapy and provide information and advice on self-care and menstrual awareness.
Methods
Sample. The sample is formed by women with dysmenorrhoea aged between 18 and 45 years, with no other abdominopelvic problems.
Design. The sample will be divided into 2 groups: Group 1. Manual therapy protocol and self-care advice and body awareness. Three sessions of manual therapy will be applied, (one at the beginning, another at 2 weeks and another at 3 weeks); Group 2 comparator. Advice on self-care and body awareness.
Evaluations:
- Clinical interview with anthropometric data and characteristics of the pathology (age, weight, height, pain characteristics) There will be 3 evaluations: Evaluation at the beginning, at the end of the treatment and a follow-up of one month.
- SF-36 quality of life scale.
- Visual Analog Scale (EVA).
- Feeling of change after treatment with the Patient Global Impression of Change Scale.
- Personal Body Satisfaction and Global Self-Perception.
- McGill pain perception questionnaire.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Manual therapy, Control group
- Keywords
- dysmenorrhoea, manual therapy
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Manual therapy protocol and self-care advice and body awareness.
Control groupOther
Advice on self-care and body awareness.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy protocol | Experimental | Manual therapy protocol and self-care advice and body awareness. Three sessions of manual therapy will be applied, (at the beginning, at 2 weeks and at 3 weeks). Receives: Other: Control group |
| Control group. | Active comparator | Advice on self-care and body awareness. Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale of Pain.
The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.
Measured: 9 weeks
Secondary outcomes (4)
SF-36 quality of life scale.
It consists of 36 items with the following scales: Physical function (items 3a, 3b, 3c, 3d, 3e, 3f, 3g, 3h, 3i, 3j), Physical role (items 4a, 4b, 4c, 4d), Corporal pain ( items 7, 8), General Health (items 1, 11a, 11b, 11c, 11d), Vitality (items 9a, 9e, 9g, 9i), Social function (items 6, 10), Emotional role (items 5a, 5b, 5c) and Mental Health (items 9b, 9c, 9d, 9f, 9h). Includes an item on the change in the general health status with respect to the previous year (item 2). To calculate the score, we must first homogenize the address of the answers by re-coding the items that require it, so that "the higher the score, the better the health condition", then the calculation of the sum of the items of each scale and, finally, the linear transformation of raw scores on a scale of 0 (worst health status for that dimension) to 100 (the best health status).
Measured: 9 weeks
Global Impression Change Scale.
To assess the change perceived after the treatment, patients are asked to rate their perception of change in the Global Impression Change Scale of the patient, and a questionnaire with a question and 7 alternatives, being 1 "maximum change" and 7 "Nothing of change".
Measured: 9 weeks
Body Satisfaction and global self-perception Questionnaire.
It contains 10 positive and 10 negative adjectives about the participant's body sensation with alternative answers ranging from 1 = Excellent to 5 = Poor. Each question is scored independently.
Measured: 9 weeks
McGill pain perception questionnaire.
This questionnaire assesses quantitative and qualitative aspects of pain, such as location, quality, temporal properties and intensity.
We use the short version, which consists of several clearly differentiated parts: Quality of pain that define the one with 66 words grouped into several categories that in turn form four large groups, pain assessment index (PRI): total and for each of the four areas (PRI), sensory, emotional PRI, valued PRI and miscellaneous PRI). The score is calculated adding that of each group of words that make up each category; b) Number of words chosen (NWC): sum of the number of pain characteristics selected by the patient; c) Pain intensity index (PPI): selected response of the item that explores this aspect.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start5 Jun 2018
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593057
- Sponsor's protocol ID
- ID0023
- Acronym
- MTDysmen
- Status last verified
- Mar 2024
- First submitted
- 1 Jun 2018
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Manual Therapy Protocol in Women With Dysmenorrhea
- ClinicalTrials.gov ID
- NCT03593057
- Acronym / sponsor ID
- MTDysmen / ID0023
- Conditions
- Dysmenorrhea Primary
- Keywords
- dysmenorrhoea, manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 19 Jul 2018 (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 objective of this clinical study would be to verify if manual therapy is effective in the treatment to reduce pain in women suffering from primary dysmenorrhea.
Material and methods In this experimental study, women diagnosed with primary dysmenorrhea will be included, which will be divided randomly into two groups: an intervention group and a comparator group.
The study will last nine weeks (3 menstrual cycles). Patients in the intervention group will receive 3 treatment sessions.
The evaluation will include pain, the quality of life, the global impression of change, personal body satisfaction and global self-perception and the pain perception.
Detailed description
Introduction The prevalence of primary dysmenorrhoea is high and has an impact on quality of life, pain and disability. The cause is due to the increase of postaglandins that can be influenced by the lowering of progesterone. In short, there is a complex relationship between hormones and the immune system.
Manual therapy increases the mobility of the sacrum and tissues of the pelvis, increasing the blood supply and the uterus that has parasympathetic innervation through the sacrum improves mobility, motility and irrigation.
The ligaments, fasciae and tissue of the pelvis improve their irrigation through fascial, mobility and visceral techniques, which would improve uterine mobility by anatomical connections with these structures. With better mobility the uterus, and therefore the smooth muscle, would have more irrigation and less pain and hypercontractivility.
The adjacent tissues, perineum, triangular ligament, innervated by the vagus nerve, improve
The main objective is the improvement of quality of life, personal body satisfaction and overall self-perception and pain reduction in women with dysmenorrhea after treatment with manual therapy and provide information and advice on self-care and menstrual awareness.
Methods
Sample. The sample is formed by women with dysmenorrhoea aged between 18 and 45 years, with no other abdominopelvic problems.
Design. The sample will be divided into 2 groups: Group 1. Manual therapy protocol and self-care advice and body awareness. Three sessions of manual therapy will be applied, (one at the beginning, another at 2 weeks and another at 3 weeks); Group 2 comparator. Advice on self-care and body awareness.
Evaluations:
- Clinical interview with anthropometric data and characteristics of the pathology (age, weight, height, pain characteristics) There will be 3 evaluations: Evaluation at the beginning, at the end of the treatment and a follow-up of one month.
- SF-36 quality of life scale.
- Visual Analog Scale (EVA).
- Feeling of change after treatment with the Patient Global Impression of Change Scale.
- Personal Body Satisfaction and Global Self-Perception.
- McGill pain perception questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy protocol | Experimental | Other: Control groupManual therapy protocol and self-care advice and body awareness. Three sessions of manual therapy will be applied, (at the beginning, at 2 weeks and at 3 weeks). |
| Control group. | Active comparator | Other: Manual therapyAdvice on self-care and body awareness. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with menstrual pain of more than 6 months of evolution.
- Women with pain equal to or greater than 4 on the visual analogue scale in more than half of their one-year menstrual cycles.
Key exclusion criteria (3 listed)
- Hormone treatment
- Contraindication to any of the treatments
- Participate in this period of no functional recovery program or physiotherapy treatment.
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 |
|---|---|---|
| Manual therapyManual therapy protocol and self-care advice and body awareness. | Other | Control group. |
| Control groupAdvice on self-care and body awareness. | Other | Manual therapy protocol |
Primary outcome
Visual Analog Scale of Pain.
Time frame: 9 weeks
The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.
4 secondary outcomes
SF-36 quality of life scale.
Time frame: 9 weeks
Global Impression Change Scale.
Time frame: 9 weeks
Body Satisfaction and global self-perception Questionnaire.
Time frame: 9 weeks
McGill pain perception questionnaire.
Time frame: 9 weeks
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 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy in people with Dysmenorrhea Primary, run by University of Valencia at 2 sites 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 2 inclusion and 3 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Analog Scale of Pain. (time frame: 9 weeks). 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 12 Mar 2024.