NCT06233006

Brief Summary

Non-specific neck pain is defined as pain in the posterior and lateral part of the neck between the superior nuchael line and the spinous process of the 1st thoracic vertebra, without neurological findings and obvious structural pathology. It is more common in women than in men. Neck pain is thought to affect upper extremity functions. Although the exact cause is unknown, it has been reported that mechanical loading, minor peripheral nerve damage and deconditioning negatively affect upper extremity functions in individuals with neck pain and reduce the quality of life. Although it is stated in the literature that patients with neck pain often experience upper extremity problems, there are a limited number of studies evaluating the relationship between the neck and upper extremity. This study was planned to determine upper extremity functions and their impact on health-related quality of life in female patients with NSHP. Female patients with NSHP over the age of 18 who apply to Tarsus State Hospital Physical Therapy and Rehabilitation Clinic, meet the inclusion criteria, and agree to participate in the study will be included in the study. With our research, patients' upper extremity functions (hand skills, hand and finger grip strength, reaction time, position sense, upper extremity strength and endurance) and health-related quality of life will be evaluated and interpreted.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

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

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

January 22, 2024

Last Update Submit

January 22, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • hand skills

    Assessed with Nine Hole Peg Test

    4 minutes

  • hand grip strength

    Assessed with Baseline Hand Dynamometer

    1 minute

  • pinch grip strength

    Assessed with Baseline Pinchmeter

    1 minute

  • reaction time

    Assessed with Nelson Hand Reaction Test

    1 minute

  • position sense

    Assessed with Baseline Digital Inclinometer

    5 minutes

  • Upper extremity strength and endurance

    Assessed with Single Arm Military Press Test

    1 minutes

  • upper extremity disability

    Assessed with DASH questionnarie

    5 minutes

Secondary Outcomes (2)

  • Health Related Quality of Life

    5 minutes

  • Neck disability

    5 minutes

Study Arms (2)

Non Spesific Neck Pain

Patients with Non Spesific Neck Pain

Other: Assessment

Healthy Control

Individuals with similar age

Other: Assessment

Interventions

upper extremity functions (hand skills, hand and finger grip strength, reaction time, position sense, upper extremity strength and endurance) and health-related quality of life

Healthy ControlNon Spesific Neck Pain

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients with Non Spesific Neck Pain

You may qualify if:

  • Having neck pain lasting more than 30 days and being diagnosed with non-specific neck pain
  • Having a score of 14/50 or above on the Neck Disability Index
  • Expressing neck pain as at least 3/10 points or above on the visual analog scale
  • Being 18 years or older
  • Female patients

You may not qualify if:

  • Previously diagnosed orthopedic diseases related to the spine
  • Undergoing surgical upper extremity surgery that may affect upper extremity functions
  • Being pregnant and having just given birth
  • Serious pathologies (such as cancer, spondylolisthesis, rheumatoid arthritis, kyphoscoliosis, scoliosis, etc., thoracic deformity or ankylosing spondylitis)
  • Symptoms of cervical spinal stenosis (such as incoordination of hands, arms and legs, bowel and bladder incontinence)
  • Radix compression (such as sensory changes, muscle weakness, or decreased reflexes)
  • History of whiplash or cervical surgery
  • Kyphoscoliosis, scoliosis etc. thorax deformity
  • Having a body mass index over 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus State Hospital

Mersin, Tarsus, 33400, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Sevgi OZALEVLİ, PhD

    Dokuz Eylul University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start

December 1, 2023

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations