INVESTIGATING THE EFFECTS SACROILIAC JOINT DYSFUNCTION ON... | NCT03426852

Studies
INVESTIGATING THE EFFECTS SACROILIAC JOINT DYSFUNCTION ON GAIT IN INDIVIDUALS WITH BACK PAIN

NCT03426852

Sponsor

Hacettepe University

Status

Unknown status

Last Update Posted

Feb 8, 2018Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Biomechanical; Lesion

Interventions

No intervention

Countries

Turkey (Türkiye)

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2018Actual

Primary Completion Date

Mar 30, 2018Estimated

Completion Date

Apr 30, 2018Estimated

First Submitted Date

Feb 2, 2018

First Submission Date that Met QC Criteria

Feb 7, 2018

First Posted Date

Feb 8, 2018Actual

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

Feb 7, 2018

Last Update Posted Date

Feb 8, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Sacroiliac joint dysfunction (SJD) is a common problem in individuals with lumbar herniation nucleus pulposus (LHNP) plus back pain. It is important to determine the effects of SJD on the gait characteristics in individuals with LHNP.Twelve individuals with LHNP (control group) and six individuals with LHNP plus SJD (study group) will be the participants of the study. Gait characteristics of participants will be evaluate with treadmill. Participants will walk at their self-selected speed for six minutes and data from 2nd minutes to 4th minutes were selected for statistical analyses. Gait speed, cadance, step lengths, time on each foot and step length variabilities will be recorded.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Individuals with lumbar back pain plus sacroiliac disc herniation	Other: No intervention
Control Group		Individuals with lumbar back pain	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Control Group Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Step Length Variability	Covariance of variability for right and left step lenghts.	First minute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have current back pain Have Lumbar Disc Herniation diagnosis Have sacroiliac dysfunction

Exclusion Criteria:

Do not want to participate Have another systemic, neurologic or orthopedic problem

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Individuals with lumbar disc herniation with or without sacroiliac dysfunction, age between 18-50 years.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University		Ankara			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055959	Intervertebral Disc Degeneration

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided