NCT05927051

Brief Summary

Lumbar disc herniation, which causes 5% of all low back pain, is the rupture of the annulus fibrosis in the intervertebral disc in the lumbar region and the protrusion of the nucleus pulposus at various degrees, and as a result, the spinal cord or the nerves arising from it are compressed.Aerobic exercise is one of the most important elements in low back pain rehabilitation.Many studies have shown that individuals with low back pain have low muscle strength of the back extensors and flexors when compared to individuals who do not show symptoms, and that these muscles are strong and their aerobic fitness is high, minimizing trauma-related musculoskeletal damage.The aim of this study is to examine the effect of core stabilization exercises on functionality and core muscles in patients with LDH.

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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

June 23, 2023

Last Update Submit

June 23, 2023

Conditions

Keywords

Lumbar Disc HerniationMcKnezie exercisesstabilization exercises

Outcome Measures

Primary Outcomes (1)

  • Core muscle thickness

    Ultrasonographic images of the transversus abdominis (TrA), lumbar multifidus (MF) and Gluteus maximus (G max) muscles will be acquired using B mode (TOSHIBA Aplio 300, Japan).

    2 minutes

Secondary Outcomes (2)

  • Visual Analog Scale

    1 minute

  • Modified Oswerty Inquiry

    2 minutes

Study Arms (3)

Stabilization exercises

EXPERIMENTAL

Core stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Other: Stabilization exercises

McKenzie exercises

EXPERIMENTAL

McKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Other: McKenzie exercises

Home exercises

EXPERIMENTAL

Home exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Other: Home exercises

Interventions

Core stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Stabilization exercises

McKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

McKenzie exercises

Home exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks

Home exercises

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 18 to 65
  • Patients who have diagnosed with LDH

You may not qualify if:

  • Patients who were pregnant
  • diagnosed with malignancy
  • had changes of medical treatment in the last 3 months
  • had dysfunction that limited physical activity such as severe neurological impairment,
  • immobility or cooperation deficits
  • had regular exercise habit (minimally three days in a week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songül Bağlan Yentür

Elâzığ, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Songül Bağlan Yentür

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Firat University

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

July 20, 2023

Primary Completion

September 20, 2023

Study Completion

October 20, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations