Pelvic Somatic DysfunctionPMEOMTNCT06266650
Unilateral vs Bilateral Application of Muscle Energy Techniques in Pelvic Somatic Dysfunction
A study testing Osteopathic Treatment Technique- Muscle Energy Treatment in people with Pelvic Somatic Dysfunction, run by The Touro College and University System at 1 site in United States.
Trial 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)?… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pelvic Somatic Dysfunction
- What is being tested?
- Osteopathic Treatment Technique- Muscle Energy Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current osteopathic medical students first-and second year.
Who cannot join
- Acute severe pelvic pain,
- Pregnancy,
- History of pelvic trauma or surgery,
- Receiving osteopathic treatment for pelvic dysfunction outside this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Touro College of Osteopathic Medicine
Harlem, New York, 10027
About this study
Official title: 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)?
Read more
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.
Read the 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.
- Conditions
- Pelvic Somatic Dysfunction
- Being tested
- Osteopathic Treatment Technique- Muscle Energy Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Treatment Technique- Muscle Energy TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Muscle Energy - One sided | Experimental | Receives pubic abduction/adduction somatic dysfunction combinations one sided Receives: Other: Osteopathic Treatment Technique- Muscle Energy Treatment |
| Pelvic Muscle Energy - two sided | Active comparator | Receives pubic abduction/adduction somatic dysfunction combinations two sided Receives: Other: Osteopathic Treatment Technique- Muscle Energy Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through treatment completion, on average 30 minutes
Secondary outcomes (2)
Anterior anatomical landmarks assessment
Anterior superior iliac spine symmetry or asymmetry
Measured: 5 minutes
Posterior anatomical landmarks assessment
Posterior superior iliac spine symmetry or asymmetry
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start30 Oct 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Somatic DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Touro College and University System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhail Volokitin, MD, DO., The Touro College and University System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266650
- Sponsor's protocol ID
- 19485
- Acronym
- PMEOMT
- Status last verified
- Nov 2024
- First submitted
- 20 Dec 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Applications of the Pubic Muscle Energy Technique for Pelvic Somatic Dysfunctions Against Their Standard Treatment Modalities.
- ClinicalTrials.gov ID
- NCT06266650
- Acronym / sponsor ID
- PMEOMT / 19485
- Conditions
- Pelvic Somatic Dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Touro College and University SystemUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pelvic Muscle Energy - One sided | Experimental | Other: Osteopathic Treatment Technique- Muscle Energy TreatmentReceives pubic abduction/adduction somatic dysfunction combinations one sided |
| Pelvic Muscle Energy - two sided | Active comparator | Other: Osteopathic Treatment Technique- Muscle Energy TreatmentReceives pubic abduction/adduction somatic dysfunction combinations two sided |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Current osteopathic medical students first-and second year.
Key exclusion criteria (4 listed)
- Acute severe pelvic pain,
- Pregnancy,
- History of pelvic trauma or surgery,
- Receiving osteopathic treatment for pelvic dysfunction outside this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Treatment Technique- Muscle Energy TreatmentMuscle 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. | Other | Pelvic Muscle Energy - One sided, Pelvic Muscle Energy - two sided |
Primary outcome
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.
2 secondary outcomes
Anterior anatomical landmarks assessment
Time frame: 5 minutes
Posterior anatomical landmarks assessment
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Pelvic Somatic Dysfunction
Recruiting
Strain-Counterstrain Treatment of Piriformis Pain
Low Back Pain, Mechanical, Piriformis Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Treatment Technique- Muscle Energy Treatment in people with Pelvic Somatic Dysfunction, run by The Touro College and University System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of pelvic somatic dysfunction (time frame: Through treatment completion, on average 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.