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

NCT06266650 | Active Not Recruiting DMC

• 1 other identifier: 19485
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Somatic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Resolution of pelvic somatic dysfunction

  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.

  Through treatment completion, on average 30 minutes

Secondary Outcomes (2)

• Anterior anatomical landmarks assessment

  5 minutes

• Posterior anatomical landmarks assessment

  5 minutes

Study Arms (2)

Pelvic Muscle Energy - One sided

EXPERIMENTAL

Receives pubic abduction/adduction somatic dysfunction combinations one sided

Other: Osteopathic Treatment Technique- Muscle Energy Treatment

Pelvic Muscle Energy - two sided

ACTIVE COMPARATOR

Receives pubic abduction/adduction somatic dysfunction combinations two sided

Other: Osteopathic Treatment Technique- Muscle Energy Treatment

Interventions

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.

Pelvic Muscle Energy - One sided; Pelvic Muscle Energy - two sided

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Current osteopathic medical students first-and second year.

You may not qualify if:

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

Sponsors & Collaborators

• The Touro College and University System: lead

Study Sites (1)

Touro College of Osteopathic Medicine

Harlem, New York, 10027, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects diagnosed with pelvic SD will be divided into two groups. One 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.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: February 20, 2024
• Study Start: October 30, 2024
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

US (1)