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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-03-30

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.

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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.

Conditions

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Endometriosis Pelvic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Manual therapy group

Patients in this group (n=20) will receive a manual therapy protocol.

Group Type EXPERIMENTAL

Manual therapy

Intervention Type OTHER

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.

Placebo group

Patients in this group (n=20) will receive a placebo treatment.

Group Type PLACEBO_COMPARATOR

Placebo treatment

Intervention Type OTHER

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.

Interventions

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Manual therapy

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.

Intervention Type OTHER

Placebo treatment

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.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No