NCT06160245

Brief Summary

Based on the reviewed literature, Core Stabilization Exercises (CSEs) have been shown to have positive effects on patients with low back pain. To our knowledge, very few studies have examined the impact of CSEs on neck pain, particularly in patients with forward head posture (FHP), despite that several authors suggested that FHP may be caused by lumbopelvic malalignment. Therefore, the purpose of the study is to assess how CSEs may affect the cervical sagittal balance parameters (CSB) in patient with FHP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 29, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

November 29, 2023

Last Update Submit

August 19, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • cervical sagittal vertical alignment

    calculated by measuring the horizontal distance between the posterosuperior corner of the C7 vertebral body and a plumb line drawn from the centroid of C2

    baseline, week 6

  • T1 slope angle

    he angle formed by drawing a line along the superior endplate of T1 and horizontal reference line at the median sagittal cervical vertebra from the CT radiographs

    baseline, week 6

  • craniovertebral angle

    the intersection of a horizontal line passing through the C7 spinous process and a line joining the midpoint of the tragus of the ear to the skin overlying the C7 spinous process.

    baseline, week 6

Secondary Outcomes (2)

  • numerical pain rating scale

    baseline, week 6

  • neck disability index

    baseline, week 6

Study Arms (2)

core stability exercise

EXPERIMENTAL

This group will receive core stabilization exercises ( MCGILL 2008), in addition to postural correction exercises described by (HARMAN 2005)

Other: exercise therapy

traditional exercise

ACTIVE COMPARATOR

This group will receive only postural correction exercises described by (HARMAN 2005)

Other: exercise therapy

Interventions

core stabilization exercises

core stability exercisetraditional exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • CVA less than 50 degrees/ neck pain for about 4 weeks

You may not qualify if:

  • Vertebrobasilar insufficiency/ cervical surgery/ cervical or TMJ fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Cairo University & AXA One-Health clinics Korba branch

Giza, Egypt

Location

Related Publications (2)

  • Shabana AMM, Ashour RS, Yamany AS, Hanafy AF. Radiographic and clinical effects of core stabilization on cervical pain and sagittal balance in forward head posture: a randomized controlled trial. Asian Spine J. 2026 Jan 6. doi: 10.31616/asj.2025.0297. Online ahead of print.

  • Shabana AMM, Hanafy AF, Yamany AS, Ashour RS. Effect of core stabilization exercises on cervical sagittal balance parameters in patients with forward head posture: a randomized controlled trial in Egypt. Asian Spine J. 2025 Feb;19(1):85-93. doi: 10.31616/asj.2024.0328. Epub 2025 Jan 20.

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

December 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations