NCT07565688

Brief Summary

This study aims to investigate the effects of forward head posture correction on neck pain, brain activity, and cognitive-motor performance. Forward head posture is a common postural problem, especially among young adults who spend long hours using smartphones and computers. It is frequently associated with neck pain, reduced mobility, and functional limitations. Emerging evidence also suggests that this postural deviation may influence brain function and increase the mental effort required during tasks that involve both thinking and movement. Participants with forward head posture and neck pain will be recruited and randomly assigned to one of three groups: an intervention group using a cervical traction device (Denneroll), a sham group using a towel roll, or a control group receiving no intervention. The intervention will be performed at home over a six-week period, with sessions conducted five times per week. The duration of each session will gradually increase based on participant tolerance to ensure safety and comfort. All participants will undergo assessments at baseline and after the intervention period. Pain intensity will be measured using a standardized pain scale. Brain activity will be assessed using a non-invasive technique called functional near-infrared spectroscopy (fNIRS), which measures changes in oxygen levels in the brain. Participants will also perform balance tasks under single-task and dual-task conditions, where they will be asked to maintain balance while performing simple cognitive tasks. In addition, cognitive function will be evaluated using standardized tests of attention, memory, and overall cognitive performance. This study will help determine whether correcting forward head posture can reduce pain and improve brain and cognitive function. The findings may provide valuable insights into the relationship between posture, pain, and brain activity, and may contribute to the development of more effective and comprehensive rehabilitation approaches for individuals with forward head posture.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started May 2027

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2027

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Forward Head PostureNeck Pain Musculoskeletal

Outcome Measures

Primary Outcomes (1)

  • The visual analog scale (VAS)

    Pain score: visual analog scale (VAS)

    Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).

Secondary Outcomes (5)

  • functional near-infrared spectroscopy (fNIRS)

    Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).

  • Symbol Digit Modalities Test (The SDMT)

    Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).

  • Brief Visuospatial Memory Test-Revised (BVMT-R)

    Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).

  • Montreal Cognitive Assessment (MoCA)

    Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).

  • Technobody Balance System (Balance performance)

    Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).

Study Arms (3)

Denneroll group (DG)

ACTIVE COMPARATOR

The intervention group will receive Denneroll cervical traction

Other: Forward Head Posture Correction

Towel group (TG)

SHAM COMPARATOR

The placebo group will receive a towel roll as an intervention

Other: Forward Head Posture Correction

control group (CG)

NO INTERVENTION

Interventions

Duration: 6 weeks Frequency: 5 sessions per week (total 30 sessions) Setting: Home-based Position: Supine Session duration: Starts at \~3 minutes, progressively increased to 15-20 minutes (as tolerated) \- Intervention: DG: The denneroll will be given under the cervical spine (based on deviation level) TG: A towel roll will be given as an intervention CG: No intervention This protocol simultaneously examines cerebral oxygenation using functional near-infrared spectroscopy (fNIRS)(HbO and HbR) , during single- and dual-task balance conditions(cognitive load-motor balance), and pain intensity using the VAS, postural alignment (craniovertebral angle),and cognitive function (MoCA, SDMT, BVMT-R) before and after intervention.

Denneroll group (DG)Towel group (TG)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \) young adults of both genders aged between 18 and 35 years 2) a craniovertebral angle (CVA) of less than 50 degrees 3) able to understand and follow simple English instructions (consistency) 4) no history of neurological disorders (MoCA\>18)

You may not qualify if:

  • \) Individuals with a history of cervical spine surgery or severe cervical trauma 2) currently receiving physiotherapy treatment for cervical spine conditions, 3) Individuals on medications (diagnosed neurological disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sharjah

Sharjah city, 27272, United Arab Emirates

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alham Alsharman, Associate Prof.

    University of Sharjah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reime Jamal Shehadeh Shalash, PhD-Teaching assistant

CONTACT

Alham Al-Sharman, PhD-Associate Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study will follow a single-blinded design in which participants will not be informed of their group allocation. Due to the nature of the intervention, blinding of the investigator delivering the intervention will not be feasible. However, standardized procedures will be implemented to minimize assessment bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will use a parallel-group interventional model in which participants are randomly assigned to one of three groups: an intervention group receiving forward head posture correction using Denneroll cervical traction, a sham group receiving a non-therapeutic towel roll intervention, and a control group receiving no intervention. Each group will be followed over a six-week period, with outcomes assessed at baseline and post-intervention. The parallel design allows for comparison of the intervention effect against both a placebo-controlled condition and a no-intervention control, thereby improving the internal validity of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD -Teaching Assistant

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start (Estimated)

May 1, 2027

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations