The Effect of Connective Tissue Massage in Women With Primary Dysmenorrhoea
Primary Purpose
Dysmenorrhea, Pelvic Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
lifestyle advice
connective tissue manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea focused on measuring Dysmenorrhea, Primary dysmenorrhea, physiotherapy, massage, connective tissue massage, connective tissue manipulation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Menstrual pain below 40 mm on the VAS
- Severe gastrointestinal, urogynecological or autoimmune disease
- other chronic pain syndromes
- psychiatric disorder
- childbirth
- positive pregnancy test
- 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
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
control
intervention
Arm Description
lifestyle advice
connective tissue manipulation
Outcomes
Primary Outcome Measures
menstrual pain intensity
Secondary Outcome Measures
Menstrual Attitude Score
Number of pain medication
Menstrual Symptom Score
Menstrual Pain Catastrophizing Score
Full Information
NCT ID
NCT02372123
First Posted
February 20, 2015
Last Updated
December 9, 2015
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT02372123
Brief Title
The Effect of Connective Tissue Massage in Women With Primary Dysmenorrhoea
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea, Pelvic Pain
Keywords
Dysmenorrhea, Primary dysmenorrhea, physiotherapy, massage, connective tissue massage, connective tissue manipulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Other
Arm Description
lifestyle advice
Arm Title
intervention
Arm Type
Active Comparator
Arm Description
connective tissue manipulation
Intervention Type
Other
Intervention Name(s)
lifestyle advice
Intervention Description
Investigators will give lifestyle advice to patients such as exercising regularly, limiting caffeine, sugar and alcohol intake, reduction or cessation of smoking
Intervention Type
Other
Intervention Name(s)
connective tissue manipulation
Intervention Description
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
Primary Outcome Measure Information:
Title
menstrual pain intensity
Time Frame
one month
Secondary Outcome Measure Information:
Title
Menstrual Attitude Score
Time Frame
one month
Title
Number of pain medication
Time Frame
one month
Title
Menstrual Symptom Score
Time Frame
one month
Title
Menstrual Pain Catastrophizing Score
Time Frame
one month
Other Pre-specified Outcome Measures:
Title
treatment satisfaction score
Time Frame
one month
Title
compliance with advices
Time Frame
one month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Menstrual pain below 40 mm on the VAS
Severe gastrointestinal, urogynecological or autoimmune disease
other chronic pain syndromes
psychiatric disorder
childbirth
positive pregnancy test
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
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
24773180
Citation
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.
Results Reference
result
PubMed Identifier
24666560
Citation
Molins-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 Reference
result
PubMed Identifier
20705214
Citation
Tu 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 Reference
result
PubMed Identifier
21875520
Citation
Holey 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 Reference
result
PubMed Identifier
24411158
Citation
Holey 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 Reference
result
PubMed Identifier
3399521
Citation
Reed 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 Reference
result
PubMed Identifier
24104772
Citation
As-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 Reference
result
PubMed Identifier
11530120
Citation
Granot 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.
Results Reference
result
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The Effect of Connective Tissue Massage in Women With Primary Dysmenorrhoea
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