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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05418751
• Other study ID #: 19866206
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

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 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.

Locations

Country	Name	City	State
Spain	Faculty of Physiotherapy, University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Depression. Beck Depression Index (BDI-II)	From 0 to 21 points. Higher scores mean greater depression.	5 minutes
Secondary	Anxiety. State Trait Anxiety Index (STAI)	Scores range from 20 to 80, with higher scores correlating with greater anxiety.	5 minutes
Secondary	Medication intake. Diary	Name of the drug, dosage and frequency of intake.	8 months
Secondary	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