NCT03426852

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

February 2, 2018

Last Update Submit

February 7, 2018

Conditions

Biomechanical; Lesion

Keywords

Biomechanical PhenomenonGaitLumbar Disc Degeneration

Outcome Measures

Primary Outcomes (1)

  • Step Length Variability

    Covariance of variability for right and left step lenghts.

    First minute

Study Arms (2)

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

No interventionOTHER

No intervention

Control GroupStudy group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 8, 2018

Study Start

January 2, 2018

Primary Completion

March 30, 2018

Study Completion

April 30, 2018

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

TU(1)