The Effect of Connective Tissue Massage in Women With Primary Dysmenorrhoea

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT02372123

Collaborator

(none)

Enrollment

Location

Arms

5.9

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea Pelvic Pain	Other: lifestyle advice Other: connective tissue manipulation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: control lifestyle advice	Other: lifestyle advice Investigators will give lifestyle advice to patients such as exercising regularly, limiting caffeine, sugar and alcohol intake, reduction or cessation of smoking
Active Comparator: intervention connective tissue manipulation	Other: lifestyle advice Investigators will give lifestyle advice to patients such as exercising regularly, limiting caffeine, sugar and alcohol intake, reduction or cessation of smoking Other: connective tissue manipulation 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

Arm

Intervention/Treatment

Other: control

lifestyle advice

Other: lifestyle advice

Investigators will give lifestyle advice to patients such as exercising regularly, limiting caffeine, sugar and alcohol intake, reduction or cessation of smoking

Active Comparator: intervention

connective tissue manipulation

Other: lifestyle advice

Investigators will give lifestyle advice to patients such as exercising regularly, limiting caffeine, sugar and alcohol intake, reduction or cessation of smoking

Other: connective tissue manipulation

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

Outcome Measures

Primary Outcome Measures

menstrual pain intensity [one month]

Secondary Outcome Measures

Menstrual Attitude Score [one month]
Number of pain medication [one month]
Menstrual Symptom Score [one month]
Menstrual Pain Catastrophizing Score [one month]

Other Outcome Measures

treatment satisfaction score [one month]
compliance with advices [one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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