DysmenorrheaNCT02372123
The Effect of Connective Tissue Massage in Women With Primary Dysmenorrhoea
A study testing lifestyle advice and connective tissue manipulation in people with Dysmenorrhea and Pelvic Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of connective tissue manipulation on pain threshold in women with primary dysmenorrhoea. According to literature, there are studies that measure the pain threshold. 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
- Dysmenorrhea, Pelvic Pain
- What is being tested?
- lifestyle advice and connective tissue manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2015to Aug 2015
- 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
- Nulliparous women: aged over 18 years, diagnosis of primary dysmenorrhea according to Primary Dysmenorrhea Consensus Guideline, having regular menstrual cycles, a history of menstrual pain starting in the first few years after menarche and menstrual pain rated higher than 40 mm on a visual analog scale considering the last six months
Who cannot join
- Menstrual pain below 40 mm on the VAS
- Severe gastrointestinal, urogynecological or autoimmune disease
- other chronic pain syndromes
- psychiatric disorder
- childbirth
- positive pregnancy test
Show all 11Show fewer
- intrauterine device
- urogynecologic surgery
- chronic medication including oral contraceptives or antidepressants for at least six months prior to study
- irregular menstrual cycles
- a history or ultrasonographic observation of pathologic conditions
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the effect of connective tissue manipulation on pain threshold in women with primary dysmenorrhoea. According to literature, there are studies that measure the pain threshold. But there is no randomized controlled trial which explore the short and long-term effects of connective tissue manipulation on primary dysmenorrhoea. Hypothesis of this study is that connective tissue manipulation increases pain threshold and decreases severity of pain in women suffer with primary dysmenorrhoea.
Read the detailed description
Dysmenorrhoea has been defined painful menstruation. It is divided primary and secondary dysmenorrhoea according to the pathophysiology. Primary dysmenorrhoea is severe menstrual pain, occurs a short time after menarche and without pelvic pathology. Secondary dysmenorrhoea is severe menstrual pain that occurs related to pelvic pathology. In primary dysmenorrhoea, pain usually begins with menstruation and ends in 48-72 hours. Pain is usually felt in the lower abdomen and lumbosacral region. Fatigue, headache, vomiting, diarrhea and constipation may be accompanied by primary dysmenorrhoea.
It is difficult to determine the incidence and etiology of dysmenorrhoea because of the variety of the criteria used in the diagnosis of the dysmenorrhoea and subjective symptoms. But current studies show that primary dysmenorrhoea is common gynecological problem that affects majority of women. Tu et al. indicated that prevalence of primary dysmenorrhoea was between 20-90% percent and 15% of cases had severe symptoms.
Although the etiology of primary dysmenorrhoea is not fully understood, excessive prostaglandin production is believed to cause abnormal uterine activity. Hyperalgesia is present especially in the deep tissue during the menstrual cycle.
Various approaches have been proposed until now for the treatment of patients with dysmenorrhoea. These are medical treatments (for example paracetamol, NSAID, oral contraceptives), alternative treatments (for example herbal products and nutritional supplements, dietary changes), surgical treatments and physiotherapy and rehabilitation approaches. Connective tissue manipulation (CTM), physiotherapy and rehabilitation approach, has been found by German physiotherapist Elizabeth Dicke in 1929. CTM is a manual reflex therapy, which produces autonomic responses via cutaneous-visceral reflexes. This safe and effective technique consists short and long tractions, which performed on the patients' skin by the skilled and experienced physiotherapist. Although the effect mechanism of CTM has not been fully understood yet, it is known that the treatment method stimulates autonomic nervous system to rebalance the parasympathetic and sympathetic functions. CTM produces autonomic stimulus when the stroke is performed on the skin and blood vessels are stimulated by autonomic nerve endings located in the tissue interfaces. It has also found that stimulation of autonomic nerve endings may results in reduction of sympathetic vasoconstrictor tone leads to vasodilatation. Stimulation of skin with strokes affects segmental reflexes. It is known that stimulation of segmental reflexes can be used in treatment of organ dysfunctions. CTM applied to affected dermatome generates reflex effects in the associated organs, provides healing by increasing circulation and decreasing pain. Skin alterations and subcutaneous tissue tension are observed in the dermatomes and myotomes, which are innervated by same spinal cord level with malfunctioning organ. In addition to these effects, powerful stimulation of cutaneous mechanoreceptor induces gate control mechanism, increases pain threshold and decreases stress hormones and muscle tension.
The aim of this study is to investigate the effect of connective tissue manipulation on pain threshold in women with primary dysmenorrhoea. According to literature, there are studies that measure the pain threshold. But there is no randomized controlled trial which explore the short and long-term effects of connective tissue manipulation on primary dysmenorrhoea. Hypothesis of this study is that connective tissue manipulation increases pain threshold and decreases severity of pain in women suffer with primary dysmenorrhoea.
- Conditions
- Dysmenorrhea, Pelvic Pain
- Being tested
- lifestyle advice, connective tissue manipulation
- Keywords
- Dysmenorrhea, Primary dysmenorrhea, physiotherapy, massage, connective tissue massage, connective tissue manipulation
- Medical subject headings
- Dysmenorrhea, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle adviceOther
Investigators will give lifestyle advice to patients such as exercising regularly, limiting caffeine, sugar and alcohol intake, reduction or cessation of smoking
connective tissue manipulationOther
Investigators will apply connective tissue manipulation on lumbosacral, lower thoracic, and anterior pelvic regions starting from the estimated time of ovulation until the next period begins
| Study group | Role | What they receive |
|---|---|---|
| control | Other | lifestyle advice Receives: Other: lifestyle advice |
| intervention | Active comparator | connective tissue manipulation Receives: Other: lifestyle advice; Other: connective tissue manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
menstrual pain intensity
Measured: one month
Secondary outcomes (4)
Menstrual Attitude Score
Measured: one month
Number of pain medication
Measured: one month
Menstrual Symptom Score
Measured: one month
Menstrual Pain Catastrophizing Score
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP KAYA, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372123
- Sponsor's protocol ID
- GO15/98
- Status last verified
- Dec 2015
- First submitted
- 20 Feb 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Arendt-Nielsen L, Madsen H, Jarrell J, Gregersen H, Drewes AM. Pain evoked by distension of the uterine cervix in women with dysmenorrhea: evidence for central sensitization. Acta Obstet Gynecol Scand. 2014 Aug;93(8):741-8. doi: 10.1111/aogs.12403. Epub 2014 May 24.
PubMed 24773180Molins-Cubero S, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, Heredia-Rizo AM, Bosca-Gandia JJ, Ricard F. Changes in pain perception after pelvis manipulation in women with primary dysmenorrhea: a randomized controlled trial. Pain Med. 2014 Sep;15(9):1455-63. doi: 10.1111/pme.12404. Epub 2014 Mar 25.
PubMed 24666560Tu CH, Niddam DM, Chao HT, Chen LF, Chen YS, Wu YT, Yeh TC, Lirng JF, Hsieh JC. Brain morphological changes associated with cyclic menstrual pain. Pain. 2010 Sep;150(3):462-468. doi: 10.1016/j.pain.2010.05.026.
PubMed 20705214Holey LA, Dixon J, Selfe J. An exploratory thermographic investigation of the effects of connective tissue massage on autonomic function. J Manipulative Physiol Ther. 2011 Sep;34(7):457-62. doi: 10.1016/j.jmpt.2011.05.012. Epub 2011 Jul 23.
PubMed 21875520Holey 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 24411158Reed BV, Held JM. Effects of sequential connective tissue massage on autonomic nervous system of middle-aged and elderly adults. Phys Ther. 1988 Aug;68(8):1231-4.
PubMed 3399521As-Sanie S, Harris RE, Harte SE, Tu FF, Neshewat G, Clauw DJ. Increased pressure pain sensitivity in women with chronic pelvic pain. Obstet Gynecol. 2013 Nov;122(5):1047-1055. doi: 10.1097/AOG.0b013e3182a7e1f5.
PubMed 24104772Granot M, Yarnitsky D, Itskovitz-Eldor J, Granovsky Y, Peer E, Zimmer EZ. Pain perception in women with dysmenorrhea. Obstet Gynecol. 2001 Sep;98(3):407-11. doi: 10.1016/s0029-7844(01)01465-x.
PubMed 11530120
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Connective Tissue Massage in Women With Primary Dysmenorrhoea
- ClinicalTrials.gov ID
- NCT02372123
- Acronym / sponsor ID
- GO15/98
- Conditions
- Dysmenorrhea, Pelvic Pain
- Keywords
- Dysmenorrhea, Primary dysmenorrhea, physiotherapy, massage, connective tissue massage, connective tissue manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 26 Feb 2015 (estimated)
- 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 aim of this study is to investigate the effect of connective tissue manipulation on pain threshold in women with primary dysmenorrhoea. According to literature, there are studies that measure the pain threshold. But there is no randomized controlled trial which explore the short and long-term effects of connective tissue manipulation on primary dysmenorrhoea. Hypothesis of this study is that connective tissue manipulation increases pain threshold and decreases severity of pain in women suffer with primary dysmenorrhoea.
Detailed description
Dysmenorrhoea has been defined painful menstruation. It is divided primary and secondary dysmenorrhoea according to the pathophysiology. Primary dysmenorrhoea is severe menstrual pain, occurs a short time after menarche and without pelvic pathology. Secondary dysmenorrhoea is severe menstrual pain that occurs related to pelvic pathology. In primary dysmenorrhoea, pain usually begins with menstruation and ends in 48-72 hours. Pain is usually felt in the lower abdomen and lumbosacral region. Fatigue, headache, vomiting, diarrhea and constipation may be accompanied by primary dysmenorrhoea.
It is difficult to determine the incidence and etiology of dysmenorrhoea because of the variety of the criteria used in the diagnosis of the dysmenorrhoea and subjective symptoms. But current studies show that primary dysmenorrhoea is common gynecological problem that affects majority of women. Tu et al. indicated that prevalence of primary dysmenorrhoea was between 20-90% percent and 15% of cases had severe symptoms.
Although the etiology of primary dysmenorrhoea is not fully understood, excessive prostaglandin production is believed to cause abnormal uterine activity. Hyperalgesia is present especially in the deep tissue during the menstrual cycle.
Various approaches have been proposed until now for the treatment of patients with dysmenorrhoea. These are medical treatments (for example paracetamol, NSAID, oral contraceptives), alternative treatments (for example herbal products and nutritional supplements, dietary changes), surgical treatments and physiotherapy and rehabilitation approaches. Connective tissue manipulation (CTM), physiotherapy and rehabilitation approach, has been found by German physiotherapist Elizabeth Dicke in 1929. CTM is a manual reflex therapy, which produces autonomic responses via cutaneous-visceral reflexes. This safe and effective technique consists short and long tractions, which performed on the patients' skin by the skilled and experienced physiotherapist. Although the effect mechanism of CTM has not been fully understood yet, it is known that the treatment method stimulates autonomic nervous system to rebalance the parasympathetic and sympathetic functions. CTM produces autonomic stimulus when the stroke is performed on the skin and blood vessels are stimulated by autonomic nerve endings located in the tissue interfaces. It has also found that stimulation of autonomic nerve endings may results in reduction of sympathetic vasoconstrictor tone leads to vasodilatation. Stimulation of skin with strokes affects segmental reflexes. It is known that stimulation of segmental reflexes can be used in treatment of organ dysfunctions. CTM applied to affected dermatome generates reflex effects in the associated organs, provides healing by increasing circulation and decreasing pain. Skin alterations and subcutaneous tissue tension are observed in the dermatomes and myotomes, which are innervated by same spinal cord level with malfunctioning organ. In addition to these effects, powerful stimulation of cutaneous mechanoreceptor induces gate control mechanism, increases pain threshold and decreases stress hormones and muscle tension.
The aim of this study is to investigate the effect of connective tissue manipulation on pain threshold in women with primary dysmenorrhoea. According to literature, there are studies that measure the pain threshold. But there is no randomized controlled trial which explore the short and long-term effects of connective tissue manipulation on primary dysmenorrhoea. Hypothesis of this study is that connective tissue manipulation increases pain threshold and decreases severity of pain in women suffer with primary dysmenorrhoea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Other | Other: lifestyle advicelifestyle advice |
| intervention | Active comparator | Other: lifestyle advice, Other: connective tissue manipulationconnective tissue manipulation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nulliparous women: aged over 18 years, diagnosis of primary dysmenorrhea according to Primary Dysmenorrhea Consensus Guideline, having regular menstrual cycles, a history of menstrual pain starting in the first few years after menarche and menstrual pain rated higher than 40 mm on a visual analog scale considering the last six months
Key exclusion criteria (11 listed)
- Menstrual pain below 40 mm on the VAS
- Severe gastrointestinal, urogynecological or autoimmune disease
- other chronic pain syndromes
- psychiatric disorder
- childbirth
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 |
|---|---|---|
| lifestyle adviceInvestigators will give lifestyle advice to patients such as exercising regularly, limiting caffeine, sugar and alcohol intake, reduction or cessation of smoking | Other | control, intervention |
| connective tissue manipulationInvestigators will apply connective tissue manipulation on lumbosacral, lower thoracic, and anterior pelvic regions starting from the estimated time of ovulation until the next period begins | Other | intervention |
Primary outcome
menstrual pain intensity
Time frame: one month
4 secondary outcomes
Menstrual Attitude Score
Time frame: one month
Number of pain medication
Time frame: one month
Menstrual Symptom Score
Time frame: one month
Menstrual Pain Catastrophizing Score
Time frame: one month
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 11 Dec 2015.
- Results publication: PubMed 24773180Arendt-Nielsen L, Madsen H, Jarrell J, Gregersen H, Drewes AM. Pain evoked by distension of the uterine cervix in women with dysmenorrhea: evidence for central sensitization. Acta Obstet Gynecol Scand. 2014 Aug;93(8):741-8. doi: 10.1111/aogs.12403. Epub 2014 May 24.
- Results publication: PubMed 24666560Molins-Cubero S, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, Heredia-Rizo AM, Bosca-Gandia JJ, Ricard F. Changes in pain perception after pelvis manipulation in women with primary dysmenorrhea: a randomized controlled trial. Pain Med. 2014 Sep;15(9):1455-63. doi: 10.1111/pme.12404. Epub 2014 Mar 25.
- Results publication: PubMed 20705214Tu CH, Niddam DM, Chao HT, Chen LF, Chen YS, Wu YT, Yeh TC, Lirng JF, Hsieh JC. Brain morphological changes associated with cyclic menstrual pain. Pain. 2010 Sep;150(3):462-468. doi: 10.1016/j.pain.2010.05.026.
- Results publication: PubMed 21875520Holey LA, Dixon J, Selfe J. An exploratory thermographic investigation of the effects of connective tissue massage on autonomic function. J Manipulative Physiol Ther. 2011 Sep;34(7):457-62. doi: 10.1016/j.jmpt.2011.05.012. Epub 2011 Jul 23.
- 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 3399521Reed BV, Held JM. Effects of sequential connective tissue massage on autonomic nervous system of middle-aged and elderly adults. Phys Ther. 1988 Aug;68(8):1231-4.
- Results publication: PubMed 24104772As-Sanie S, Harris RE, Harte SE, Tu FF, Neshewat G, Clauw DJ. Increased pressure pain sensitivity in women with chronic pelvic pain. Obstet Gynecol. 2013 Nov;122(5):1047-1055. doi: 10.1097/AOG.0b013e3182a7e1f5.
- Results publication: PubMed 11530120Granot M, Yarnitsky D, Itskovitz-Eldor J, Granovsky Y, Peer E, Zimmer EZ. Pain perception in women with dysmenorrhea. Obstet Gynecol. 2001 Sep;98(3):407-11. doi: 10.1016/s0029-7844(01)01465-x.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle advice and connective tissue manipulation in people with Dysmenorrhea and Pelvic Pain, 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 1 inclusion and 11 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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
menstrual pain intensity (time frame: one month). 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 NCT02372123, which also lists 8 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 11 Dec 2015.