The Effect of Connective Tissue Massage in Women With Primary Dysmenorrhoea
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 20, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedDecember 11, 2015
December 1, 2015
6 months
February 20, 2015
December 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
menstrual pain intensity
one month
Secondary Outcomes (4)
Menstrual Attitude Score
one month
Number of pain medication
one month
Menstrual Symptom Score
one month
Menstrual Pain Catastrophizing Score
one month
Other Outcomes (2)
treatment satisfaction score
one month
compliance with advices
one month
Study Arms (2)
control
OTHERlifestyle advice
intervention
ACTIVE COMPARATORconnective tissue manipulation
Interventions
Investigators will give lifestyle advice to patients such as exercising regularly, limiting caffeine, sugar and alcohol intake, reduction or cessation of smoking
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, 06100, Turkey (Türkiye)
Related 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 2014 May 24.
PMID: 24773180RESULTMolins-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.
PMID: 24666560RESULTTu 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.
PMID: 20705214RESULTHoley 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.
PMID: 21875520RESULTHoley 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.
PMID: 24411158RESULTReed 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.
PMID: 3399521RESULTAs-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.
PMID: 24104772RESULTGranot 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.
PMID: 11530120RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- project manager
Study Record Dates
First Submitted
February 20, 2015
First Posted
February 26, 2015
Study Start
February 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
December 11, 2015
Record last verified: 2015-12