- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06266650
Unilateral vs Bilateral Application of Muscle Energy Techniques in Pelvic Somatic Dysfunction (PMEOMT)
Novel Applications of the Pubic Muscle Energy Technique for Pelvic Somatic Dysfunctions Against Their Standard Treatment Modalities.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pelvic Muscle Energy - One sided
Receives pubic abduction/adduction somatic dysfunction combinations one sided
|
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.
|
Active Comparator: Pelvic Muscle Energy - two sided
Receives pubic abduction/adduction somatic dysfunction combinations two sided
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Through treatment completion, on average 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anterior anatomical landmarks assessment
Time Frame: 5 minutes
|
Anterior superior iliac spine symmetry or asymmetry
|
5 minutes
|
Posterior anatomical landmarks assessment
Time Frame: 5 minutes
|
Posterior superior iliac spine symmetry or asymmetry
|
5 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19485
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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