Clinical trial NCT05418751: Effectiveness of a Manual Therapy Protocol on Women With Pelvic Pain Due to Endometriosis
Official title: Effectiveness of a Manual Therapy Protocol on Women With Pelvic Pain Due to Endometriosis: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Pelvic Pain
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Endometriosis symptoms. The endometriosis health profile questionnaire (EHP-30Q)
timeFrame: 5 minutes
Secondary outcomes:
measure: Health related quality of life. 36-Item Short Form Survey (SF-36)
timeFrame: 5 minutes
measure: Lumbar range of movement. Modified Schober Test
timeFrame: 5 minutes
measure: Depression. Beck Depression Index (BDI-II)
timeFrame: 5 minutes
measure: Anxiety. State Trait Anxiety Index (STAI)
timeFrame: 5 minutes
measure: Medication intake. Diary
timeFrame: 8 months
measure: Impression of change after treatment. Patient global Perception of Change Scale (PGICS)
timeFrame: 1 minute
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy, University of Valencia
Study officials:
affiliation: University of Valencia
name: Marta Inglés, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aredo JV, Heyrana KJ, Karp BI, Shah JP, Stratton P. Relating Chronic Pelvic Pain and Endometriosis to Signs of Sensitization and Myofascial Pain and Dysfunction. Semin Reprod Med. 2017 Jan;35(1):88-97. doi: 10.1055/s-0036-1597123. Epub 2017 Jan 3.
citation: Arribas-Romano A, Fernandez-Carnero J, Molina-Rueda F, Angulo-Diaz-Parreno S, Navarro-Santana MJ. Efficacy of Physical Therapy on Nociceptive Pain Processing Alterations in Patients with Chronic Musculoskeletal Pain: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2502-2517. doi: 10.1093/pm/pnz366.
citation: Berghmans B. Physiotherapy for pelvic pain and female sexual dysfunction: an untapped resource. Int Urogynecol J. 2018 May;29(5):631-638. doi: 10.1007/s00192-017-3536-8. Epub 2018 Jan 9.
citation: Sillem M, Juhasz-Boss I, Klausmeier I, Mechsner S, Siedentopf F, Solomayer E. Osteopathy for Endometriosis and Chronic Pelvic Pain - a Pilot Study. Geburtshilfe Frauenheilkd. 2016 Sep;76(9):960-963. doi: 10.1055/s-0042-111010.
citation: Zullo F, Spagnolo E, Saccone G, Acunzo M, Xodo S, Ceccaroni M, Berghella V. Endometriosis and obstetrics complications: a systematic review and meta-analysis. Fertil Steril. 2017 Oct;108(4):667-672.e5. doi: 10.1016/j.fertnstert.2017.07.019. Epub 2017 Sep 2.