NCT05149183

Brief Summary

to investigate the effect of cervical stability training on somatosensory evoked potential and cervical spine in forward head posture

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 not_applicable

Timeline
Completed

Started Dec 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 25, 2021

Last Update Submit

November 25, 2021

Conditions

Keywords

cervical stabilitysomatosensory evoked potentialforward head posture

Outcome Measures

Primary Outcomes (2)

  • somatosensory evoked potential

    somatosensory evoked potential will be measured by electromyograph device

    up to eight weeks

  • craniovertebral angle

    craniovertebral angle will be measured photographically by surgimap program

    up to eight weeks

Secondary Outcomes (5)

  • pain intensity level

    up to eight weeks

  • functional disability

    up to eight weeks

  • cervical range of motion

    up to eight weeks

  • endurance test

    up to eight weeks

  • cervical curvature

    up to eight weeks

Study Arms (2)

cervical stability training

EXPERIMENTAL

cervical stability training will be received three times a week for eight weeks

Other: cervical stability trainingOther: traditional treatment

traditional treatment

ACTIVE COMPARATOR

traditional treatment will be received three times a week for eight weeks

Other: traditional treatment

Interventions

cervical stability training will be contain three phases, each phase has six positions ( supine, forearms, sidelying, four point kneeling, sitting and standing position)

cervical stability training

TENS, hot packs, stretching exercise of superficial neck muscles, and postural advice.

cervical stability trainingtraditional treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult participant (18-to-40years old) with forward head posture, BMI 20-to-25 kg/m², The area of mechanical neck pain will defined to the cervical region, possibly with referred pain into the occipit, nuchal muscles, and shoulders, All patients will have chronic neck pain for more than 3 months, Craniovertebral angle of ˂ 49.

You may not qualify if:

  • Signs of serious pathology (e.g., rheumatoid diseases, ankylosing spondylitis), History of cervical spine surgery, History of trauma or fractures in cervical spine, Signs of cervical radiculopathy or myelopathy, Vascular syndrome such as vertebrobasilar insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salah Eid Ahmed Ali

Giza, 11251, Egypt

Location

Central Study Contacts

salah E Ahmed, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: this trial has two groups, one experimental and one control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 8, 2021

Study Start

December 15, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

December 8, 2021

Record last verified: 2021-11

Locations