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

U

University of Valencia

Status

Completed

Conditions

Pelvic Pain
Endometriosis

Treatments

Other: Manual therapy
Other: Placebo treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05418751
19866206

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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