The Relationship of the Joint Blockage and Muscle Spasm | NCT07264530

Studies
The Relationship of the Joint Blockage and Muscle Spasm

NCT07264530

Sponsor

Charles University, Czech Republic

Status

Completed

Last Update Posted

Dec 4, 2025Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

NO DECOMPENSATED ILLNESS
Muscle Cramps
Joint Dysfunction

Interventions

Mobilization technique for sacroiliac joint

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2025Actual

Primary Completion Date

Nov 10, 2025Actual

Completion Date

Nov 10, 2025Actual

First Submitted Date

Nov 20, 2025

First Submission Date that Met QC Criteria

Dec 2, 2025

First Posted Date

Dec 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2025

Last Update Posted Date

Dec 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Malá Jitka, PhDr. Jitka Malá, Ph.D., Charles University, Czech RepublicPrincipal Investigator

Lead Sponsor

Charles University, Czech RepublicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An interventional study aimed at verifying the effect of sacroiliac joint blockage on changes in piriformis muscle tension. The study was conducted on 40 subjects, both male and female. Physical therapy methods were used to diagnose muscle tension as a diagnostic tool, along with a visual analogue scale. The intervention was performed using manual mobilisation techniques commonly used in clinical practice. The effectiveness was verified using the same physical therapy diagnostic tool as at the beginning. The entire research process is time-consuming, taking up to 1 hour per examinee.

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%.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental investigated group	Experimental	Group to which the mobilization technique will be applied to the sacroiliac joint according to "Cluster of Lasslet"	Procedure: Mobilization technique for sacroiliac joint
Control non-investigated group	No Intervention	A control group that undergoes an initial examination but subsequently receives no therapy. After 30 minutes of quiet rest, it is examined again.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mobilization technique for sacroiliac joint	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changing of piriformis muscle irritability	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miroslav Petr, Doc.	Charles University, Faculty of physical education and sport	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vokovice		Prague			Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

not enough experience

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009120	Muscle Cramp
D007592	Joint Diseases
D013035	Spasm

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

A group of suitable subjects (n=40) is divided into an experimental group and a control group (n=20). All subjects meet the study's inclusion criteria. All subjects undergo the same initial examination, including palpation of the piriformis muscle, joint play of the sacroiliac joint, and a visual analogue scale. The experimental group is treated with mobilisation techniques and left to rest for 30 minutes. The control group receives no mobilisation intervention and is only left to rest for 30 minutes. Subsequently, an exit examination identical to the entrance examination is performed. The results are entered into Excel tables and further processed using statistical methods.