The Effect of Connective Tissue Massage in Women With Primary Dysmenorrhoea

Pelvic Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372123
• Other study ID #: GO15/98
• Status: Completed
• Phase: N/A
• First received: February 20, 2015
• Last updated: December 9, 2015
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Pelvic Pain

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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 2 — View 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):1047-55. doi: 10.1097/AOG.0b013e3182a7e1f5. — View 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. — View 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. — View 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. Review. — View Citation

Molins-Cubero S, Rodríguez-Blanco C, Oliva-Pascual-Vaca A, Heredia-Rizo AM, Boscá-Gandía 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 — View 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. — View 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):462-8. doi: 10.1016/j.pain.2010.05.026. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	treatment satisfaction score		one month	No
Other	compliance with advices		one month	No
Primary	menstrual pain intensity		one month	No
Secondary	Menstrual Attitude Score		one month	No
Secondary	Number of pain medication		one month	No
Secondary	Menstrual Symptom Score		one month	No
Secondary	Menstrual Pain Catastrophizing Score		one month	No