NCT05650346

Brief Summary

To investigate the efficacy of adding cervical \& thoracic spinal mobilization techniques to deep cervical training compared to deep cervical training alone on Pain, Neck functional ability, Craniovertebral angle.

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
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

November 23, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

November 23, 2022

Last Update Submit

January 9, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Craniovertebral Angle

    The CVA was formed at the intersection of the horizontal line, which passed through the back and the line, which joined the tragus of the ear and the back. The Patient Will Be In Standing Position and the image will be taken from the lateral view then the image will be inserted to IMAGEJ Software To Measure The Angle

    One Month

  • Deep Neck Core Strength

    The the patient in supine crook lying with the neck in a neutral position. The uninflated pressure sensor will be placed behind the neck so that it abutted the occiput and is inflated to a stable baseline pressure of 20 mm Hg.The movement will perform gently and slowly as a head nodding action (as if saying "yes"). The Cranio cervical flexion exercise the activation and endurance of the deep cervical flexors in progressive inner range positions as the patient attempted to sequentially target five, 2-mm Hg progressive pressure increases from the baseline of 20 mm Hg to a maximum of 30 mm Hg as well as to maintain a isometric contraction at the progressive pressures as an endurance task.

    One Month

Study Arms (3)

Control Group ( Deep Cervical Training )

ACTIVE COMPARATOR
Other: Deep Cervical Training

Experimental group I (Deep cervical training + Upper cervical mobilization group)

EXPERIMENTAL
Other: Deep Cervical TrainingOther: Deep cervical training + Upper cervical mobilization group

Experimental group II (Deep cervical training + Upper thoracic mobilization group)

EXPERIMENTAL
Other: Deep Cervical TrainingOther: Deep cervical training + Upper thoracic mobilization group

Interventions

The Cranio cervical flexion exercise will be performed with the patient in supine crook lying with the neck in a neutral position (no pillow) such that the line of the face is horizontal and a line bisecting the neck longitudinally is horizontal to the testing surface. The uninflated pressure sensor will be placed behind the neck so that it abutted the occiput and is inflated to a stable baseline pressure of 20 mm Hg, a standard pressure sufficient to fill the space between the testing surface and the neck but not push the neck into a lordosis. the patient attempted to sequentially target five, 2-mm Hg progressive pressure increases from the baseline of 20 mm Hg to a maximum of 30 mm Hg as well as to maintain a isometric contraction at the progressive pressures as an endurance task.

Control Group ( Deep Cervical Training )Experimental group I (Deep cervical training + Upper cervical mobilization group)Experimental group II (Deep cervical training + Upper thoracic mobilization group)

1. the patient in supine crook lying with the neck in a neutral position.The uninflated pressure sensor will be placed behind the neck so that it abutted the occiput and is inflated to a stable baseline pressure of 20 mm Hg, a standard pressure sufficient to fill the space between the testing surface and the neck but not push the neck into a lordosis. the patient attempted to sequentially target five, 2-mm Hg progressive pressure increases from the baseline of 20 mm Hg to a maximum of 30 mm Hg 2. The therapist will cover the rear of the cervical part of the participant with his right hand for stabilization, and will place his thumb and index fingers on the atlas of the participant. To conduct the atlanto-occipital mobilization, the therapist will place his left hand at the right side of the participant and at the same time will place his fifth finger under the occipital area and will pull the participant's head toward his trunk.

Experimental group I (Deep cervical training + Upper cervical mobilization group)

1. The Cranio cervical flexion exercise will be performed with the patient in supine crook lying with the neck in a neutral position (no pillow) such that the line of the face is horizontal and a line bisecting the neck longitudinally is horizontal to the testing surface. The uninflated pressure sensor will be placed behind the neck so that it abutted the occiput and is inflated to a stable baseline pressure of 20 mm Hg, a standard pressure sufficient to fill the space between the testing surface and the neck but not push the neck into a lordosis. the patient attempted to sequentially target five, 2-mm Hg progressive pressure increases from the baseline of 20 mm Hg to a maximum of 30 mm Hg as well as to maintain a isometric contraction at the progressive pressures as an endurance task. 2. The participants will be placed in the prone position and the therapist will stand facing the joint where the mobilization will be applied to improve the extension of the upper thoracic spine (T1-2).

Experimental group II (Deep cervical training + Upper thoracic mobilization group)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The craniovertebral angle is less than 50 degrees.
  • Age ranges from 18 to 25 years old.
  • Forward head is associated with neck pain.

You may not qualify if:

  • A history of any of the following conditions:
  • Previous surgery regarding the spine or shoulders.
  • Vertebral fractures regarding the cervical spine or the skull.
  • Positive neurological signs or evidence of spinal compression
  • headaches prior to the onset of neck pain and without cervical origin
  • Inner ear or vestibular Problems
  • Whiplash Injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Egyptian Chinese University

Cairo, 00202, Egypt

RECRUITING

Central Study Contacts

Ahmed Ma Hamed, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 14, 2022

Study Start

January 10, 2023

Primary Completion

February 20, 2023

Study Completion

February 20, 2023

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations