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Treatment with manual therapy technique for pain relief in patients with Endometriosis

Effect and mechanism of the manual Microphysiotherapy technique action associated with the Biological Laws methodology in the treatment of Endometriosis: a controlled and randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7z4qkcj
Enrollment
Unknown
Registered
2024-12-23
Start date
2022-08-08
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Interventions

Women diagnosed with endometriosis will be invited to participate in the research and those who meet the inclusion criteria, sign the Informed Consent Form and accept to participate in the research wi
b) Study power 80%
c) Percentage of unexposed positives 30%
d) Ratio of unexposed to exposed in the sample 1.0
e) Odds ratio of 3.0. Thus, the total sample size will be 150 patients. Participants will be randomly allocated into three groups: placebo group (GP, n= 50), Microphysiotherapy group (GM, n= 50) and M
E02.779

Sponsors

Universidade do Sul de Santa Catarina
Lead Sponsor
Universidade do Sul de Santa Catarina
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women; who have a medical diagnosis of endometriosis; in the age group from 18 years to 45 years; without distinction of color/race or ethnicity; who live in the cities of Pato Branco-PR or Palhoça-SC and/or nearby cities; who agree to participate in all stages of the research, signing the Informed Consent Form (ICO)

Exclusion criteria

Exclusion criteria: Women who have other acute or chronic inflammatory pathologies; who are continuously using anti-inflammatories or analgesics; women who have previously undergone laparoscopic surgery or other surgeries for endometriosis

Design outcomes

Primary

MeasureTime frame
It is expected to find a 50% reduction in pain related to Endometriosis, based on the observation of the pre- and post-intervention variation, in the participants of the Microphysiotherapy technique group associated with the Biological Laws methodology, verified through the pain questionnaire. McGill and the Visual Analogue Pain Scale.

Secondary

MeasureTime frame
It is expected to find improvements in the quality of life of research participants treated in the group with the Microphysiotherapy technique and in the group with the Microphysiotherapy technique associated with the Biological Laws methodology, compared to the placebo group, in the results of the post-service questionnaire , with a variation of more than 5% in positive results.;It is expected to find a reduction in the indexes of oxidative stress markers, comparing before and after intervention, with p<0.05, in research participants treated in the group with the Microphysiotherapy technique and in the group with the Microphysiotherapy technique associated with the methodology of Biological Laws.;It is expected to find a reduction in the indexes of oxidative stress markers, comparing before and after intervention, with p<0.05, in research participants treated in the group with the Microphysiotherapy technique and in the group with the Microphysiotherapy technique associated with the methodology of Biological Laws.;It is expected to find improvements in the perception of change in health status and satisfaction, through the results of the Patient Global Impression of Change Scale, in research participants treated in the group with the Microphysiotherapy technique and in the group with the associated Microphysiotherapy technique. the Biological Laws methodology, in the comparison after the first intervention and after the last intervention, with p<0.05, compared to the Placebo Group.

Countries

Brazil

Contacts

Public ContactIvan Bonaldo

Universidade do Sul de Santa Catarina

ivanbonaldo@yahoo.com.br+55(46)999812112

Outcome results

None listed

Source: REBEC (via WHO ICTRP)