Effectiveness of a Manual Therapy Protocol on Women With Pelvic Pain Due to Endometriosis: a Randomised Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- University of Valencia
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Endometriosis symptoms. The endometriosis health profile questionnaire (EHP-30Q)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Endometriosis is a debilitating disease with features of chronic inflammation that affects 10-15% of women of reproductive age. Pelvic pain is one of the most common symptoms in women with endometriosis, and many of them report that it affects their quality of life. In addition, women with endometriosis, especially those with pelvic pain, also have an increased vulnerability to various psychiatric disorders, such as depression and anxiety.
In this context, physical therapy can contribute to the multidisciplinary assessment and treatment of pelvic pain. In addition, manual therapy could improve certain variables related to central sensitization, such as inhibitory pain regulation and neuronal excitability in the dorsal horn of the medulla, in patients with chronic pain. Some prospective studies have applied manual therapy in patients with pelvic pain due to endometriosis, and have shown a trend towards improvement of pain and quality of life. Moreover, it is considered a well-tolerated and accepted treatment by patients.
However, to date, it has not been investigated whether the application of a manual therapy protocol improves pelvic pain and other endometriosis-associated symptoms, lumbar mobility, medication intake, depression and anxiety levels, and quality of life in women with endometriosis-associated pelvic pain compared to a placebo treatment.
Detailed Description
Endometriosis is a debilitating disease with features of chronic inflammation that affects 10-15% of women of reproductive age. Pelvic pain is one of the most common symptoms in women with endometriosis, and many of them report that it affects their quality of life. In addition, women with endometriosis, especially those with pelvic pain, also have an increased vulnerability to various psychiatric disorders, such as depression and anxiety. In this context, physical therapy can contribute to the multidisciplinary assessment and treatment of pelvic pain. In addition, manual therapy could improve certain variables related to central sensitization, such as inhibitory pain regulation and neuronal excitability in the dorsal horn of the medulla, in patients with chronic pain. Some prospective studies have applied manual therapy in patients with pelvic pain due to endometriosis, and have shown a trend towards improvement of pain and quality of life. Moreover, it is considered a well-tolerated and accepted treatment by patients. However, to date, it has not been investigated whether the application of a manual therapy protocol improves pelvic pain and other endometriosis-associated symptoms, lumbar mobility, medication intake, depression and anxiety levels, and quality of life in women with endometriosis-associated pelvic pain compared to a placebo treatment. Therefore, this is a randomized clinical trial in which two groups of twenty people in each group will participate, with different interventions: * Experimental group: manual therapy protocol. * Placebo group: placebo treatment. Participants will be evaluated in four moments, at baseline, post-intervention, 1-month follow-up and 6-month follow-up. Data analysis will be performed with SPSS statistic program (v24). Normality and homoscedasticity will be analyzed by Shapiro-Wilk t-test and Levene test, respectively. Multifactorial ANOVA will be performed with two groups (experimental and placebo group) and four-time assessments. For comparation between groups Bonferroni will be used. When p\<0.05 statistically significant differences will be assumed.
Investigators
Marta Inglés de la Torre
Professor
University of Valencia
Eligibility Criteria
Inclusion Criteria
- •Pre-menopausal woman aged between 18 and 50 years.
- •Diagnosis of endometriosis and associated pelvic pain.
Exclusion Criteria
- •Being pregnant.
- •Having rheumatic or degenerative neurological diseases, as well as any other injury or disease that causes pelvic pain.
- •Any pelvic surgery of less than one year of evolution (for example, cesarean sections).
- •Having received physical therapy treatment within the last three months.
Outcomes
Primary Outcomes
Endometriosis symptoms. The endometriosis health profile questionnaire (EHP-30Q)
Time Frame: 5 minutes
5-point Likert scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=always. Raw scores for the questions within a scale are summed and transformed to a 0-100 scale, with higher scores indicating worse health-related quality of life.
Secondary Outcomes
- Impression of change after treatment. Patient global Perception of Change Scale (PGICS)(1 minute)
- Medication intake. Diary(8 months)
- Lumbar range of movement. Modified Schober Test(5 minutes)
- Depression. Beck Depression Index (BDI-II)(5 minutes)
- Health related quality of life. 36-Item Short Form Survey (SF-36)(5 minutes)
- Anxiety. State Trait Anxiety Index (STAI)(5 minutes)