Functional Relationships Between the Temporomandibular Joint and the Pelvis in Women With Gynecological Diseases of Genital Prolapse and Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.
研究概览
简要总结
1 Recruitment. 2. Collection of written consents for the study. 3. Random assignment to groups with and without intervention. 4. Completion of questionnaires by study participants, postural pattern assessment, temporomandibular joint assessment, and platform assessment.
5. Performance of visceral therapy in the group with intervention, in the group without intervention placebo. Duration 5 weeks, treatment 1x per week at the same time of day and given day e.g. Mondays only.
6. Reassessment as in step 4. 7. Data collection, statistical analyses. 8. Interpretation of results for female participants. 9. Preparation of results for scientific publications.
详细描述
Methods
After taking a detailed history, patients will be asked to:
- Completing: the SF-36 quality of life assessment questionnaire and Female Sexual Function Index assessment, and marking on a numerical scale their pain sensations for the temporomandibular joint and for the pelvis, World Health Organization Quality of Life BREF (WHOQOL-BREF).
The SF-36 questionnaire, FSFI scale, World Health Organization Quality of Life BREF (WHOQOL-BREF) and numerical scale (assessing pain sensations for the temporomandibular joint and pelvic joint), will also be subjected to completion/checking after the completion of manual visceral treatments in groups with physiotherapy intervention for both conditions. 2. Type of postural pattern according to Hall-Wernham-Littlejohn: type I - normal, type II - anterior pelvic tilt, type III - posterior pelvic tilt.
3 Pelvic type assessment: normal, high, low; pelvic type will be assessed in each patient and in groups with physiotherapeutic intervention for both conditions before and after manual visceral treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Women will be randomly assigned to a test and control group according to their disease. The person performing the visceral tests and techniques will not know which group the woman belongs to. The evaluator of the results will not know whether they are the group with or without visceral techniques.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written consent to participate in the study.
- •Female patients after surgical treatment with prolapse of reproductive organs and diagnosed endometriosis.
排除标准
- •No written consent to participate in the study.
- •Injury to the temporomandibular joint and pelvis.
- •Fibromyalgia.
- •Rheumatic diseases.
- •At each stage of the experiment if the patient decides that she does not want to participate she is excluded.
结局指标
主要结局
Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.
时间窗: Time point one: before starting visceral therapy and placebo,1 st week
Each patient will complete a questionnaire.
platforms
时间窗: Time point one: before starting visceral therapy and placebo,1 st week
Each patient will have a postural stability assessment prior to testing.No platform manufacturer provides standards. The platform is equipped with sensors - it collects the force of the feet and gives how the center of gravity is located, that is, the front-back, side-to-side tilts are given.
postural pattern by Halla-Wernhama-Littlejohna
时间窗: Time point one: before starting visceral therapy and placeb1 st weeko,
Before the test, each patient will have a postural pattern assessment. Evaluating the pattern of type 1 anterior tilt of the body, type 2 normal, type 3 posterior tilt.
NRS
时间窗: Time point one: before starting visceral therapy and placebo, 1 st week
Each patient will mark on the NRS scale the sensation of pain before the tests. Scale of 1-10, the higher the value the greater the pain experience.
CromWell (measurement of oral dilation)
时间窗: Time point one: before starting visceral therapy and placebo,1 st week
Before the test, each patient will have their mouth opening measured with an electronic caliper.There are no standards given, it is a measurement of the dilation of the mouth.
According to the Polish version of the questionnaire, the highest point value, i.e. 171, indicates the lowest rank in the quality of life assessment, while the lowest point value indicates the highest level of quality of life.
时间窗: Time point one: before starting visceral therapy and placebo,1 st week
Each patient will complete a questionnaire on the evaluation of quality of life.Assessment: physical functioning, limitations due to physical health, pain perception, general sense of health, vitality, social functioning, emotional functioning and mental health.
pelvic type assessment
时间窗: Time point one: before starting visceral therapy and placebo,1 st week
Before the test, each patient will have a pelvic type assessment. High-assimilated type: hip plates above the L5 segment: overloaded type: hip plates below the L4 segment; normal type: hip plates at the level of the L4-L5 segment.
standarised questonarie by Kulesa-Morawiecka et al.
时间窗: Time point one: before starting visceral therapy and placebo,1 st week
Each patient will complete a questionnaire on the evaluation of the temporomandibular joint. Scale of 0-10 points, 0 - means no strength of head and neck muscles, 10 - means strong tension of head and neck muscles.
visceral techniques and placebo
时间窗: 1 st week, 2nd week, 3rd week,4th week, 5 week
The intervention group will have visceral therapy performed. The group without intervention will only have their hands held on the pelvis.
次要结局
- NRS(Time point two: after visceral therapy and placebo, 5th week)
- platforms(Time point two: after visceral therapy and placebo, 5th week)
- postural pattern by Halla-Wernhama-Littlejohna(Time point two: after visceral therapy and placebo, 5th week)
- pelvic type assessment(Time point two: after visceral therapy and placebo,5 th week)
- CromWell (measurement of oral dilation)(Time point two: after visceral therapy and placebo, 5th week)
- standarised questonarie by Kulesa-Morawiecka et al.(Time point two: after visceral therapy and placebo, 5th week)
- According to the Polish version of the questionnaire, the highest point value, i.e. 171, indicates the lowest rank in the quality of life assessment, while the lowest point value indicates the highest level of quality of life.(Time point two: after visceral therapy and placebo, 5th week)
- Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.(Time point two: after visceral therapy and placebo, 5th week)
- World Health Organization Quality of Life BREF (WHOQOL-BREF)(Time point two: after visceral therapy and placebo, 5th week)
研究者
Małgorzata Wójcik
PhD PT, principal investigator, research manager
Poznan University of Physical Education