Effectiveness of a Manual Therapy Protocol on Women With Pelvic Pain Due to Endometriosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of a Manual Therapy Protocol on Women With Pelvic Pain Due to Endometriosis: a Randomised Clinical Trial

Conditions
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Endometriosis, Pelvic Pain

Intervention / Treatment
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* Other: Manual therapy
* Other: Placebo treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual therapy group<br>Patients in this group (n=20) will receive a manual therapy protocol. | Other: Manual therapy<br>* Participants will received a manual therapy protocol consisting of the following techniques: manipulation of the occipito-atlanto-axial joint (C0-C1-C2), suboccipital inhibition technique, manipulation of the thoracolumbar hinge (T12-L1), global manipulation of the bilateral pelvis, global abdominal hemodynamic technique, functional technique of the pelvic diaphragm and stretching of the lumbopelvic musculature.<br>|
| Placebo Comparator: Placebo group<br>Patients in this group (n=20) will receive a placebo treatment. | Other: Placebo treatment<br>* Participants will receive light contact on the same points and for the same amount of time as the experimental group, with no intention to treat.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometriosis symptoms. The endometriosis health profile questionnaire (EHP-30Q) | 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. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life. 36-Item Short Form Survey (SF-36) | From 0 to 100 points. Higher scores mean a better outcome. | 5 minutes | 
| Lumbar range of movement. Modified Schober Test | Higher scores mean a better outcome.< 2cm indicates severe restriction in lumbar flexion, 2-4 cm indicates moderate restriction and >4 cm indicates without restriction. | 5 minutes | 
| Depression. Beck Depression Index (BDI-II) | From 0 to 21 points. Higher scores mean greater depression. | 5 minutes | 
| Anxiety. State Trait Anxiety Index (STAI) | Scores range from 20 to 80, with higher scores correlating with greater anxiety. | 5 minutes | 
| Medication intake. Diary | Name of the drug, dosage and frequency of intake. | 8 months | 
| Impression of change after treatment. Patient global Perception of Change Scale (PGICS) | From 1 to 7. Scale where 7=very much improved, 6= much improved, 5=minimally improved, 4=no change, 3=minimally worse, 2=much worse, 1=very much worse. | 1 minute |