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

NCT05418751 | Completed

• 1 other identifier: 19866206
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Health related quality of life. 36-Item Short Form Survey (SF-36)

  5 minutes

• Lumbar range of movement. Modified Schober Test

  5 minutes

• Depression. Beck Depression Index (BDI-II)

  5 minutes

• Anxiety. State Trait Anxiety Index (STAI)

  5 minutes

• Medication intake. Diary

  8 months

Study Arms (2)

Manual therapy group

EXPERIMENTAL

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

Other: Manual therapy

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo treatment

Interventions

Manual therapy 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.

Manual therapy group

Placebo treatment 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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal woman aged between 18 and 50 years.
• Diagnosis of endometriosis and associated pelvic pain.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy, University of Valencia

Valencia, 46022, Spain

Location

Related 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.

  PMID: 28049214 BACKGROUND

• 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.

  PMID: 32100027 BACKGROUND

• 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.

  PMID: 29318334 BACKGROUND

• 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.

  PMID: 27681520 BACKGROUND

• 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.

  PMID: 28874260 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Marta Inglés, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: November 1, 2021
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

ES (1)