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NCT Number: NCT06266650

Unilateral vs Bilateral Application of Muscle Energy Techniques in Pelvic Somatic Dysfunction

The goal of this clinical trial is to compare the efficacy of pelvic muscle energy technique online against the traditional full length osteopathic pelvic treatment protocol. The main question it aims to answer are

• Can one single pelvic muscle energy technique can correct all pelvic somatic dysfunctions (SD)?

Participants will

* be positioned by the physician into the area of treatment into a position of resistance, which is the restrictive barrier. * be instructed to use the targeted muscles for 3-5 seconds in the direction of ease while the physician provides a counterforce. * be instructed to stop contracting their muscles and evaluate the area for decreased tension, then repositions the patient into their new restrictive barrier. * These steps are repeated three to five times and then the dysfunction is reevaluated.

Subjects diagnosed with pelvic SD will be divided into two groups. One group will be treated with traditional one and be compared with the pelvic muscle energy group.

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Touro College of Osteopathic Medicine

Harlem, New York, 10027, United States

About this study

Osteopathic muscle energy technique (MET) is a well-known modality widely used by osteopathic practitioners. MET can be applied to different regions and segments of the body, is well tolerated and effective in reducing muscle hypertonicity and pain sensation. MET involves a patient actively using their muscles on request from a precisely controlled position, in a specific direction, against a distinctly executed counter force. The group of pelvic MET consists of specific variations directed to particular somatic dysfunction (SD) of innominate and pubic bones, such as pelvic shears, pelvic outflares and pelvic inflares. All techniques are well known and widely used. Based on empirical clinical observations, not confirmed by any research, it was suggested that pubic abduction/adduction SD MET combination should be able to correct all pelvic SD including innominate SD.

The investigators intend to assess if application of abduction/adduction SD combination MET may resolve any one-sided diagnosed pelvic SD.

MET involves a patient actively using their muscles on request from a precisely controlled position, in a specific direction, against a distinctly executed counter force. During MET, the physician positions the area of treatment into a position of resistance, which is the restrictive barrier. The physician then instructs the patient to use the targeted muscles for 3-5 seconds in the direction of ease while the physician provides a counterforce. The physician then tells the patient to stop contracting their muscles and evaluate the area for decreased tension, then repositions the patient into their new restrictive barrier. These steps are repeated three to five times and then the dysfunction is reevaluated.

Subjects diagnosed with pelvic SD will be divided into two groups. The control group will be treated with traditional one-sided MET, the second group will be treated with combination MET. Results of post-treatment exams will be collected and statistically analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Current osteopathic medical students first-and second year.

Exclusion criteria

  • Acute severe pelvic pain,
  • Pregnancy,
  • History of pelvic trauma or surgery,
  • Receiving osteopathic treatment for pelvic dysfunction outside this study.

Treatment and study plan

Osteopathic Treatment Technique- Muscle Energy Treatment

Other

Muscle Energy Treatment involves a patient actively using their muscles on request from a precisely controlled position, in a specific direction, against a distinctly executed counter force. During Muscle Energy Treatment, the physician positions the area of treatment into a position of resistance, which is the restrictive barrier. The physician then instructs the patient to use the targeted muscles for 3-5 seconds in the direction of ease while the physician provides a counterforce. The physician then tells the patient to stop contracting their muscles and evaluate the area for decreased tension, then repositions the patient into their new restrictive barrier. These steps are repeated three to five times and then the dysfunction is reevaluated.

Primary outcomes

  1. Resolution of pelvic somatic dysfunction

    Time frame: Through treatment completion, on average 30 minutes

    Restoration of anatomical landmarks symmetry

    Tested using forward flexion test - Standing upright subject bends forward and motion in sacroiliac joint is evaluated. The side where the investigator's thumb moves farthest is the restricted side. This side will be treated with muscle energry.

    Resolution will show symmetry between the sacroiliac joints.

Secondary outcomes

  1. Anterior anatomical landmarks assessment

    Time frame: 5 minutes

    Anterior superior iliac spine symmetry or asymmetry

  2. Posterior anatomical landmarks assessment

    Time frame: 5 minutes

    Posterior superior iliac spine symmetry or asymmetry

Sponsors and collaborators

Lead sponsor

The Touro College and University System

Other

Registry information

Official study title

Novel Applications of the Pubic Muscle Energy Technique for Pelvic Somatic Dysfunctions Against Their Standard Treatment Modalities.

Acronym: PMEOMT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.