NCT06745960

Brief Summary

The study aims are:

  1. 1.To investigate the effect of electrical stimulation (interferential current) on forward head posture and protracted shoulder in adolescents.
  2. 2.To investigate the effect of electrical stimulation on cervical pain, cervical ROM, neck muscle strength, and quality of life in adolescents with forward head posture and protracted shoulder.

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 Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

December 9, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 9, 2024

Last Update Submit

December 18, 2024

Conditions

Keywords

electrical stimulationinterferential currentadolescence

Outcome Measures

Primary Outcomes (4)

  • shoulder angle (SA)

    To measure Shoulder Angle (SA) of rounded shoulder, a line from anterolateral aspect of acromion to C7 will be taken and a horizontal line from anterolateral aspect of acromion , it will be considered as forward shoulder when the angle is 52 degree or less.

    From enrollment to the end of treatment at 8 weeks

  • craniovertebral angle (CVA)

    To measure Craniovertebral Angle (CVA) of forward head posture, a line from C7 to tragus of the ear will be taken and a horizontal line from C7 (the normal CVA more than 50 degree).

    From enrollment to the end of treatment at 8 weeks

  • head tilt angle (HTA)

    To measure head tilt angle (HTA) or cranial angle (CA) the angle of the line between the canthus of the eye and horizontal line from the tragus, the head tilt angles is 17.74 ± 4.9 degrees in people with normal head posture.

    From enrollment to the end of treatment at 8 weeks

  • head position angle (HPA)

    To measure head position angle (HPA) angle between the tragus manubrium line and the line extending from the center point of chin to the tragus, the angle is 38.1 ± 4.9 degrees in people with normal head posture.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (3)

  • Pain sensation

    From enrollment to the end of treatment at 8 weeks

  • cervical range of motion

    From enrollment to the end of treatment at 8 weeks

  • neck muscles strength

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

intervention group

ACTIVE COMPARATOR

study group (interferential current )

Device: electrical muscle stimulation device (EMS gymna)Other: physical therapy program

physical therapy exercises group

PLACEBO COMPARATOR

control group (exercise group)

Other: physical therapy program

Interventions

muscle stimulant device

intervention group

neck exercises

intervention groupphysical therapy exercises group

Eligibility Criteria

Age15 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Girls aged between (15-18) years old.
  • Normal weight with BMI ranging from (16-25).
  • Adolescents with mild and moderate forward head posture(FHP).
  • Adolescents with mild and moderate neck pain.
  • Adolescents with protracted shoulder.

You may not qualify if:

  • Cervical disc.
  • Previous Shoulder trauma within last 6months.
  • Shoulder surgery.
  • Cervical fracture.
  • Congenital posture deformity.
  • Inflammatory disease, spinal tumor, spinal compression, spinal cord infection.
  • Taking any medication for pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Dokki, Giza Governorate, Egypt

Location

Related Publications (2)

  • Elgendy MH, Ghaffar MAA, Sabbahi SAE, Abutaleb EES, Elsayed SEB. Efficacy of head postural correction program on craniovertebral angle, scapular position, and dominant hand grip strength in forward head posture subjects: A randomized controlled trial. Physiother Res Int. 2024 Jul;29(3):e2093. doi: 10.1002/pri.2093.

    PMID: 38780139BACKGROUND
  • Titcomb DA, Melton BF, Miyashita T, Bland HW. Evidence-Based Corrective Exercise Intervention for Forward Head Posture in Adolescents and Young Adults Without Musculoskeletal Pathology: A Critically Appraised Topic. J Sport Rehabil. 2022 Feb 16;31(5):640-644. doi: 10.1123/jsr.2021-0381. Print 2022 Jul 1.

    PMID: 35172275BACKGROUND

Related Links

Study Officials

  • asmaa O SAYED

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 24, 2024

Study Start

January 1, 2025

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations