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

April 3, 2023 updated by: Marta Inglés de la Torre, University of Valencia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46022
        • Faculty of Physiotherapy, University of Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual therapy group
Patients in this group (n=20) will receive a manual therapy protocol.
Other: 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.
Placebo Comparator: Placebo group
Patients in this group (n=20) will receive a placebo treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life. 36-Item Short Form Survey (SF-36)
Time Frame: 5 minutes
From 0 to 100 points. Higher scores mean a better outcome.
5 minutes
Lumbar range of movement. Modified Schober Test
Time Frame: 5 minutes
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)
Time Frame: 5 minutes
From 0 to 21 points. Higher scores mean greater depression.
5 minutes
Anxiety. State Trait Anxiety Index (STAI)
Time Frame: 5 minutes
Scores range from 20 to 80, with higher scores correlating with greater anxiety.
5 minutes
Medication intake. Diary
Time Frame: 8 months
Name of the drug, dosage and frequency of intake.
8 months
Impression of change after treatment. Patient global Perception of Change Scale (PGICS)
Time Frame: 1 minute
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Marta Inglés, PhD, University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

June 9, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19866206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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