Primary DysmenorrheaNCT03914014
The Effects of Connective Tissue Manipulation in Primary Dysmenorrhea
A study testing connective tissue manipulation in people with Primary Dysmenorrhea, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary: The aim of the present study is to investigate the efficacy of connective tissue massage in patients with primary dysmenorrhea. The present study is designed as a randomized placebo controlled study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- connective tissue manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Feb 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being volunteer to participate in the study
- Having regular menstrual cycles (28 ± 7 days)
- Being nulliparous
- Having history of the onset of menstrual pain in the first few years after menarche
- Considering the last 6 months, pain intensity >4 on the Visual Analog Scale.
Who cannot join
- Severe gastrointestinal, urogynecologic or autoimmune disease, other chronic pain syndromes, psychiatric disorder
- Pregnancy
- Use of intrauterine device
- Use of pharmacologic agents (except analgesics or non-NSAID) or non-pharmacological agent
- Urogynecological surgery
- Oral contraceptive or antidepressant use during the last 6 months
- Having an irregular menstrual cycle
- Endometriosis associated with suspected dysmenorrhea, pathologic condition associated with uterine pain such as fibroids, or ultrasonographic examination
Trial locations and contacts
1 site in 1 country.
About this study
Brief Summary: The aim of the present study is to investigate the efficacy of connective tissue massage in patients with primary dysmenorrhea. The present study is designed as a randomized placebo controlled study. Patients with primary dysmenorrhea and who agreed to participate in the study will be randomly divided into three groups. Connective tissue massage will be applied to the patients in the intervention group. Placebo ultrasound treatment will be applied to the patients in the placebo group. No application will be applied to the patients in the control group. As the research design includes the placebo group and the control group, it will be determined that if significant differences between the intervention and placebo groups are observed, this treatment effect is not related to a placebo effect or is not due to the natural course of the disease. If significant differences are found, the efficacy of the connective tissue manipulation in primary dysmenorrhea will be revealed and connective tissue manipulation may be an alternative approach to pharmacological approaches and other commonly used applications. This may reduce the need for pharmacological agents and reduce or eliminate the side effects associated with these agents.
According to the literature, there are studies that investigate short-term effects of connective tissue massage on symptoms of primary dysmenorrhea and quality of life. However, there is no long-term follow-up randomized placebo-controlled study investigating the effect of connective tissue massage on menstrual pain and symptoms.
Read the detailed description
Primary dysmenorrhea is defined as cramping pain in the lower abdomen that occurs before or during menstruation without identifiable pelvic pathology. Secondary symptoms include nausea, vomiting, fatigue, back pain, headaches, dizziness, and diarrhea. Primary dysmenorrhea has been reported as the leading cause of recurrent absenteeism from school or work in adolescent girls and young women, and it is considered to be a common disorder among women of reproductive age. The greater percentages of depression and anxiety are more common in patients with severe dysmenorrhea compared to those without dysmenorrhea. The prevalence of dysmenorrhea varies between 25-97%, and approximately 20% of them have severe pain.
Treatment in primary dysmenorrhea can be classified as pharmacological, non-pharmacological and complementary therapies. Pharmacological therapies focus on the reduction of menstrual pain and relaxation of the uterine muscles with non-steroidal anti-inflammatory drugs (NSAIDs) or oral contraceptive pills. Management of dysmenorrhea with these pharmacological agents is associated with side effects such as nausea, breast tenderness, inter-menstrual bleeding and auditory and visual disturbances. Therefore, non-pharmacological approaches are needed in the treatment of dysmenorrhea. Non-pharmacological approaches to relieve dysmenorrhea symptoms include acupuncture, reflexology, biofeedback, transcutaneous electrical stimulation, relaxation therapy, massage therapy, and exercise. Complementary therapies include essential fatty acids, vitamins, herbal medicine, and aromatherapy. It has been known that previous studies investigating the efficacy of these approaches in primary dysmenorrhea do not have a control or placebo-control group or they reveal the effectiveness of combined applications.
Connective tissue manipulation is a manually administered reflex therapy or a massage application. It may target superficial connective tissues and may stimulate segmental and supra-segmental autonomic cutaneous-visceral reflexes to restore autonomic balance and reduce dysfunction in affected internal organs. Therefore, connective tissue manipulation can be used to increase circulation of the uterus by stimulating segmental reflexes and to reduce congestion and menstrual pain. Although the effect of connective tissue massage on a wide range of health problems such as painful syndromes, vascular problems or bowel dysfunction is investigated, there is limited evidence of its use in primary dysmenorrhea. There is no randomized placebo-controlled study investigating the effects of connective tissue massage on menstrual pain and symptoms of dysmenorrhea. Therefore, the aim of the present study is to determine the effectiveness of connective tissue massage by the randomized placebo-controlled design in patients with primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- connective tissue manipulation, placebo ultrasound
- Keywords
- connective tissue massage, massage, menstrual pain, treatment
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connective tissue manipulationOther
From the estimated date of ovulation to the onset of menstrual bleeding, connective tissue massage will be applied to the sacral, lumbar, lower thoracic and anterior pelvic regions for 5 days per week. The application will take 10 min. During the massage treatment, the physiotherapist will touch the end of the middle finger with the skin of the patient and apply the skin to the pull. The patient will be in the supine position during the treatment of the anterior pelvic region while the patient is in the sitting position during the treatment of the back area.
placebo ultrasoundOther
From the estimated date of ovulation to the beginning of the next menstrual bleeding, placebo ultrasound will be applied a total of 10 minutes (5 minutes for sacral and lumbar, and lower thoracic regions and 5 min for the anterior pelvic region). Placebo ultrasound application will be performed with superficial circular movements without applying excessive pressure. During the application, the device will only be switched on, the dose will not be adjusted and the patient will be given an image of ultrasound dose.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | connective tissue manipulation Receives: Other: connective tissue manipulation |
| placebo ultrasound | Placebo comparator | placebo ultrasound Receives: Other: placebo ultrasound |
| control | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be assessed by 0-10 cm Visual Analogue Scale. The score ranges between 0 and 10. Higher scores indicate higher pain intensity.
Measured: change from baseline pain intensity to 6 months
Secondary outcomes (3)
Anxiety level
Anxiety level will be assessed with the State- Trait Anxiety Inventory (STAI). The STAI consists of two scale (state anxiety scale and trait anxiety scale) to measure the state and trait anxiety levels separately. Therefore, two scores are obtained from the STAI for the state and trait anxiety levels. The scores of state and trait anxiety scales range between 20-80. Higher scores indicate higher anxiety level.
Measured: change from baseline anxiety level to 6 months
Psychological status
Psychological status will be evaluated by the Beck Depression Inventory (BDI). The BDI consists of 21 questions. The total score of BDI ranges from 0 to 63. The greater scores on the BDI demonstrates more severe depressive symptoms.
Measured: change from baseline psychological status to 6 months
Self-reported improvement
Self-reported improvement will be evaluated by the 7-point Likert type scale. The items of this scale are as follows: 1) much much better, 2) much better, 3) a little better, 4) no change, 5) a little worse, 6) much worse, and 7) much much worse. The total score ranges between 1 and 7. Greater scores indicate lower perception of self-reported improvement.
Measured: change from baseline self-reported improvement to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start1 May 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Hacettepe UniversityThe 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP ÖZGÜL, Hacettepe University
- Investigators
- Ceren Gursen, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914014
- Sponsor's protocol ID
- 2018-158
- Status last verified
- Nov 2021
- First submitted
- 11 Apr 2019
- Last updated
- 23 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kannan P, Claydon LS. Some physiotherapy treatments may relieve menstrual pain in women with primary dysmenorrhea: a systematic review. J Physiother. 2014 Mar;60(1):13-21. doi: 10.1016/j.jphys.2013.12.003. Epub 2014 Apr 24.
PubMed 24856936Holey LA, Dixon J. Connective tissue manipulation: a review of theory and clinical evidence. J Bodyw Mov Ther. 2014 Jan;18(1):112-8. doi: 10.1016/j.jbmt.2013.08.003. Epub 2013 Sep 8.
PubMed 24411158Demirturk F, Erkek ZY, Alparslan O, Demirturk F, Demir O, Inanir A. Comparison of Reflexology and Connective Tissue Manipulation in Participants with Primary Dysmenorrhea. J Altern Complement Med. 2016 Jan;22(1):38-44. doi: 10.1089/acm.2015.0050. Epub 2015 Sep 18.
PubMed 26382885Ozgul S, Uzelpasaci E, Orhan C, Baran E, Beksac MS, Akbayrak T. Short-term effects of connective tissue manipulation in women with primary dysmenorrhea: A randomized controlled trial. Complement Ther Clin Pract. 2018 Nov;33:1-6. doi: 10.1016/j.ctcp.2018.07.007. Epub 2018 Jul 21.
PubMed 30396605
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Connective Tissue Manipulation in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT03914014
- Acronym / sponsor ID
- 2018-158
- Conditions
- Primary Dysmenorrhea
- Keywords
- connective tissue massage, massage, menstrual pain, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 12 Apr 2019 (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.
Brief Summary: The aim of the present study is to investigate the efficacy of connective tissue massage in patients with primary dysmenorrhea. The present study is designed as a randomized placebo controlled study. Patients with primary dysmenorrhea and who agreed to participate in the study will be randomly divided into three groups. Connective tissue massage will be applied to the patients in the intervention group. Placebo ultrasound treatment will be applied to the patients in the placebo group. No application will be applied to the patients in the control group. As the research design includes the placebo group and the control group, it will be determined that if significant differences between the intervention and placebo groups are observed, this treatment effect is not related to a placebo effect or is not due to the natural course of the disease. If significant differences are found, the efficacy of the connective tissue manipulation in primary dysmenorrhea will be revealed and connective tissue manipulation may be an alternative approach to pharmacological approaches and other commonly used applications. This may reduce the need for pharmacological agents and reduce or eliminate the side effects associated with these agents.
According to the literature, there are studies that investigate short-term effects of connective tissue massage on symptoms of primary dysmenorrhea and quality of life. However, there is no long-term follow-up randomized placebo-controlled study investigating the effect of connective tissue massage on menstrual pain and symptoms.
Detailed description
Primary dysmenorrhea is defined as cramping pain in the lower abdomen that occurs before or during menstruation without identifiable pelvic pathology. Secondary symptoms include nausea, vomiting, fatigue, back pain, headaches, dizziness, and diarrhea. Primary dysmenorrhea has been reported as the leading cause of recurrent absenteeism from school or work in adolescent girls and young women, and it is considered to be a common disorder among women of reproductive age. The greater percentages of depression and anxiety are more common in patients with severe dysmenorrhea compared to those without dysmenorrhea. The prevalence of dysmenorrhea varies between 25-97%, and approximately 20% of them have severe pain.
Treatment in primary dysmenorrhea can be classified as pharmacological, non-pharmacological and complementary therapies. Pharmacological therapies focus on the reduction of menstrual pain and relaxation of the uterine muscles with non-steroidal anti-inflammatory drugs (NSAIDs) or oral contraceptive pills. Management of dysmenorrhea with these pharmacological agents is associated with side effects such as nausea, breast tenderness, inter-menstrual bleeding and auditory and visual disturbances. Therefore, non-pharmacological approaches are needed in the treatment of dysmenorrhea. Non-pharmacological approaches to relieve dysmenorrhea symptoms include acupuncture, reflexology, biofeedback, transcutaneous electrical stimulation, relaxation therapy, massage therapy, and exercise. Complementary therapies include essential fatty acids, vitamins, herbal medicine, and aromatherapy. It has been known that previous studies investigating the efficacy of these approaches in primary dysmenorrhea do not have a control or placebo-control group or they reveal the effectiveness of combined applications.
Connective tissue manipulation is a manually administered reflex therapy or a massage application. It may target superficial connective tissues and may stimulate segmental and supra-segmental autonomic cutaneous-visceral reflexes to restore autonomic balance and reduce dysfunction in affected internal organs. Therefore, connective tissue manipulation can be used to increase circulation of the uterus by stimulating segmental reflexes and to reduce congestion and menstrual pain. Although the effect of connective tissue massage on a wide range of health problems such as painful syndromes, vascular problems or bowel dysfunction is investigated, there is limited evidence of its use in primary dysmenorrhea. There is no randomized placebo-controlled study investigating the effects of connective tissue massage on menstrual pain and symptoms of dysmenorrhea. Therefore, the aim of the present study is to determine the effectiveness of connective tissue massage by the randomized placebo-controlled design in patients with primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Other: connective tissue manipulationconnective tissue manipulation |
| placebo ultrasound | Placebo comparator | Other: placebo ultrasoundplacebo ultrasound |
| control | No intervention | –control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being volunteer to participate in the study
- Having regular menstrual cycles (28 ± 7 days)
- Being nulliparous
- Having history of the onset of menstrual pain in the first few years after menarche
- Considering the last 6 months, pain intensity >4 on the Visual Analog Scale.
Key exclusion criteria (8 listed)
- Severe gastrointestinal, urogynecologic or autoimmune disease, other chronic pain syndromes, psychiatric disorder
- Pregnancy
- Use of intrauterine device
- Use of pharmacologic agents (except analgesics or non-NSAID) or non-pharmacological agent
- Urogynecological surgery
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 manipulationFrom the estimated date of ovulation to the onset of menstrual bleeding, connective tissue massage will be applied to the sacral, lumbar, lower thoracic and anterior pelvic regions for 5 days per week. The application will take 10 min. During the massage treatment, the physiotherapist will touch the end of the middle finger with the skin of the patient and apply the skin to the pull. The patient will be in the supine position during the treatment of the anterior pelvic region while the patient is in the sitting position during the treatment of the back area. | Other | intervention |
| placebo ultrasoundFrom the estimated date of ovulation to the beginning of the next menstrual bleeding, placebo ultrasound will be applied a total of 10 minutes (5 minutes for sacral and lumbar, and lower thoracic regions and 5 min for the anterior pelvic region). Placebo ultrasound application will be performed with superficial circular movements without applying excessive pressure. During the application, the device will only be switched on, the dose will not be adjusted and the patient will be given an image of ultrasound dose. | Other | placebo ultrasound |
Primary outcome
Pain intensity
Time frame: change from baseline pain intensity to 6 months
Pain intensity will be assessed by 0-10 cm Visual Analogue Scale. The score ranges between 0 and 10. Higher scores indicate higher pain intensity.
3 secondary outcomes
Anxiety level
Time frame: change from baseline anxiety level to 6 months
Psychological status
Time frame: change from baseline psychological status to 6 months
Self-reported improvement
Time frame: change from baseline self-reported improvement to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Results publication: PubMed 24856936Kannan P, Claydon LS. Some physiotherapy treatments may relieve menstrual pain in women with primary dysmenorrhea: a systematic review. J Physiother. 2014 Mar;60(1):13-21. doi: 10.1016/j.jphys.2013.12.003. Epub 2014 Apr 24.
- Results publication: PubMed 24411158Holey LA, Dixon J. Connective tissue manipulation: a review of theory and clinical evidence. J Bodyw Mov Ther. 2014 Jan;18(1):112-8. doi: 10.1016/j.jbmt.2013.08.003. Epub 2013 Sep 8.
- Results publication: PubMed 26382885Demirturk F, Erkek ZY, Alparslan O, Demirturk F, Demir O, Inanir A. Comparison of Reflexology and Connective Tissue Manipulation in Participants with Primary Dysmenorrhea. J Altern Complement Med. 2016 Jan;22(1):38-44. doi: 10.1089/acm.2015.0050. Epub 2015 Sep 18.
- Results publication: PubMed 30396605Ozgul S, Uzelpasaci E, Orhan C, Baran E, Beksac MS, Akbayrak T. Short-term effects of connective tissue manipulation in women with primary dysmenorrhea: A randomized controlled trial. Complement Ther Clin Pract. 2018 Nov;33:1-6. doi: 10.1016/j.ctcp.2018.07.007. Epub 2018 Jul 21.
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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.
Ceren Gursen principal investigator
Hacettepe 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 Hacettepe University 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 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 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 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. Some participants in this study may receive a placebo. 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?
Pain intensity (time frame: change from baseline pain intensity to 6 months). 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 NCT03914014, which also lists 4 linked publications.
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 23 Nov 2021.