- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07264530
The Relationship of the Joint Blockage and Muscle Spasm
The Relationship Between the Blockage of the Sacroiliac Joint (SI) and the Spasm of the Piriformis Muscle.
Study Overview
Status
Intervention / Treatment
Detailed Description
Objectives: The main aim of this study is to summarise current knowledge about the relationship between functional joint blockage and chained muscle spasm. To verify the relationship between sacroiliac joint blockage and piriformis muscle using combined therapy as a diagnostic tool, where the main parameter monitored will be the intensity of piriformis muscle irritability before and after sacroiliac joint mobilisation.
Methods: Measurements will be taken on a group of 40 subjects. The research sample consists of people aged 18-60, randomly divided into an experimental and a control group. All subjects underwent an initial palpation examination of the piriformis muscle, during which the level of pain was determined on a numerical pain scale. All subjects then underwent measurement of the piriformis muscle's irritability threshold using the "Beauty-line device 4000 Topline" device. The experimental group then underwent therapeutic intervention in the form of sacroiliac joint mobilisation using the "Cluster of Lasslet" technique. This was followed by 30 minutes of relaxation. The control group received no therapeutic intervention and only 30 minutes of relaxation between the initial and final examinations. Both groups then underwent the same final examination as at the beginning.
The investigators expect a change in piriformis muscle hypertonicity after sacroiliac joint mobilisation, including a reduction in pain in this muscle, at a statistical significance level of 5%.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Prague, Czechia
- Vokovice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- palpation sensitivity of the piriformis muscle in the piriformis line,
- limited joint play of the sacroiliac joint,
- pain in the lower back, groin, perineum, buttocks, or hips, tenderness in the sacrum,
- pain or weakness during resisted abduction at 90° flexion in the hip joint,
- positive piriformis sign, positive Freiberg's test, positive Trendelenburg's test, or positive Pace's abduction test.
- At least 50% of the accompanying signs of sacroiliac joint blockage must be present in each subject.
Exclusion Criteria:
- acute (primarily infectious) diseases,
- persons in acute condition after an accident,
- persons recovering from an accident/illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental investigated group
Group to which the mobilization technique will be applied to the sacroiliac joint according to "Cluster of Lasslet"
|
The subject lies on their stomach, mobilization maneuvers are performed, a total of 4 maneuvers according to the recommended "Cluster of Lasslet" procedure for the sacroiliac joint.
|
|
No Intervention: Control non-investigated group
A control group that undergoes an initial examination but subsequently receives no therapy.
After 30 minutes of quiet rest, it is examined again.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changing of piriformis muscle irritability
Time Frame: one hour at all
|
After removing the sacroiliac joint blockage, the irritability threshold of the piriformis muscle increases and its painfulness decreases.
The reduction in pain will be evident based on instrumental measurements using the Beauty-line device and palpation examination.
|
one hour at all
|
Collaborators and Investigators
Investigators
- Study Chair: Miroslav Petr, Doc., Charles University, Faculty of physical education and sport
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Svobodova, Piriformis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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