NCT07071792

Brief Summary

The aim and objective of this study is to check the prevalence of helmet associated neck pain among TCS riders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

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

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

July 6, 2025

Last Update Submit

July 15, 2025

Conditions

Neck Pain

Keywords

Helmet useneck painmotorcycleshead protective devicesdisability

Outcome Measures

Primary Outcomes (2)

  • Neck Disability Index

    to measure helmet associated neck disability, ranging from 0 (no disability) to 50 (complete disability)

    12 weeks

  • Numeric Pain Rating Scale

    to measure helmet associated neck pain, high score indicates worse patient condition

    12 weeks

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales were selected for this study because, in Pakistan, the occupation of TCS rider is predominantly held by men. Therefore, to ensure relevance and accuracy, the study population was limited to male participants
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

TCS riders who use helmets for at least 6 hours per day

You may qualify if:

  • year age
  • male TCS riders
  • All TCS riders who are using helmet for past six months or above
  • Minimum duration of helmet use
  • who will be willing to participate

You may not qualify if:

  • Subjects had any known disorder that causes pain in neck or upper limb
  • Any traumatic injury to cervical spine (fractures)
  • cervical spine pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TCS centers

Gujranwala, Punjab Province, 52250, Pakistan

Location

Related Publications (2)

  • Makkiyah FA, Natashia K, Kristanti M, Purwaningastuti DA. Associated Factors with Neck Pain among Productive Adult Motorcyclists in Metropolitan University Settings : A Cross-Sectional Study. J Korean Neurosurg Soc. 2025 Jul;68(4):425-435. doi: 10.3340/jkns.2024.0114. Epub 2024 Nov 26.

    PMID: 39591956BACKGROUND

  • Harrison MF, Forde KA, Albert WJ, Croll JC, Neary JP. Posture and Helmet Load Influences on Neck Muscle Activation. Aerosp Med Hum Perform. 2016 Jan;87(1):48-53. doi: 10.3357/AMHP.4301.2016.

    PMID: 26735233BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syeda Mahnoor Hassan, MSPT

    Elite College of ManagementSciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2025

First Posted

July 17, 2025

Study Start

April 1, 2025

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations

PA(1)