NCT04859127

Brief Summary

INTRODUCTION Non-specific chronic neck pain is one of the most common musculoskeletal disorders today. Factors related to neck pain are diverse and can affect the person in different ways. In order to determine the appropriate physical therapy and rehabilitation program for patients, the functional status of the patients should be evaluated carefully and the factors affecting this situation and the relationships between them should be taken into account. Parameters such as pain, balance, disability, muscular performance are associated with neck pain. The aim of our study is to examine the relationship between pain and kinesophobia and muscle performance, balance and dual task in individuals with nonspecific chronic neck pain and to compare them with asymptomatic individuals. Materials and Methods: The study included 44 individuals aged 18-65 who applied to Kırıkkale University Faculty of Medicine Physical Medicine and Rehabilitation Clinic and were diagnosed with non-specific chronic neck pain by a specialist, and 44 asymptomatic individuals between the ages of 18-65 who did not experience neck pain for the last 1 year for the control group. will be. A total of 88 individuals will be included. We will evaluate kinesiophobia, pain density, muscles performance, dual task etc. FINDINGS AND DISCUSSION: Data acquired at the end of this study will be compared by using appropriate statistical methods and then it will be discussed in comparison with national and international literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

April 13, 2021

Last Update Submit

January 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Investigation Of The Relationship Between Pain And Fear Of Motion And Muscle Performance, Balance And Dual Task In Individuals With Non-Specific Chronic Neck Pain And Comparing With Asymptomatic Individuals

    Pain Intensity Assessment VAS out of 10 points ROM Evaluation Electrogoniometer the measured angle Muscle Strength Assessment will be measured the neck flexor and extensor muscles, Stabilizer and Hand-Held Dynamometer and recorded in newtons and mm / hg Muscular Endurance Assessment the extensor and flexor muscles of the neck will be recorded (s) Muscle Shortness Assessment pectoral, adductor and internal rotator muscles (short-normal-long) Kinesiophobia Assessment Tampa Kinesophobia Scale (score) Neck Disability Assessment Neck Disability Index (score) Dynamic Balance Assessment Star Balance Test (cm) SBT score = (Reaching distance / Leg length) \* 100 Static Balance Assessment One-Standing Standing Test (s) Physical PerformanceTUG Test (s) Walking Speed Assessment 10 m walking test (s) Dual Task Assessment motor-motor and motor-cognitive during walking (s) Dual Task Effect = (Single Task - Dual Task ) / Single Task x 100 (s=seconds)

    16 weeks

Study Arms (2)

Patient Group

The criteria for inclusion in the study were determined as voluntary patients between the ages of 18-65 with neck pain lasting more than 3 months who were clinically diagnosed with chronic neck pain by a specialist physician. Within the scope of the evaluation for the assessment of pain by visual analog scale (VAS), standard evaluation posture Postural Analysis, range of motion for the evaluation of Elektrogonyometer, Nov stabilizer and force evaluation for a hand-held Dynamometer, Nov for brevity, brevity reviews left internal rotator muscles of the pectoral muscles with standard, fear of movement kinezyofobi Tampa scale for the assessment of the neck in apology etc.

Other: effects of neck pain

Control Group

Asymptomatic individuals between the ages of 18-65 who have not experienced neck pain during the last 1 year will be included in the control group. Within the scope of the evaluation for the assessment of pain by visual analog scale (VAS), standard evaluation posture Postural Analysis, range of motion for the evaluation of Elektrogonyometer, Nov stabilizer and force evaluation for a hand-held Dynamometer, Nov for brevity, brevity reviews left internal rotator muscles of the pectoral muscles with standard, fear of movement kinezyofobi Tampa scale for the assessment of the neck in apology etc.

Other: effects of neck pain

Interventions

Within the scope of the evaluation for the assessment of pain by visual analog scale (VAS), standard evaluation posture Postural Analysis, range of motion for the evaluation of Elektrogonyometer, Nov stabilizer and force evaluation for a hand-held Dynamometer, Nov for brevity, brevity reviews left internal rotator muscles of the pectoral muscles with standard, fear of movement kinezyofobi Tampa scale for the assessment of the neck in apology, questioning of the status of the inquiry Neck Disability Survey, stars in the evaluation of balance dynamic balance test, stand on one leg Test in the evaluation of static balance, dynamic balance and physical performance Term rise and walk test, gait speed for the assessment of the 10-meter walk test and dual-task for the evaluation of the motor-the motor and motor-Cognitive dual-task will be used for the evaluation.

Control GroupPatient Group

Eligibility Criteria

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

Between the ages of 18-65 men and women.

You may qualify if:

  • Between the ages of 18-65,
  • Have neck pain that lasts longer than 3 months,
  • Volunteer patients diagnosed with chronic neck pain by a specialist,
  • Has not experienced neck pain for the last 1 year,
  • Asymptomatic individuals between the ages of 18-65,

You may not qualify if:

  • Having had cervical spine and shoulder surgery,
  • Neck pain caused by different pathologies (tumor, rheumatoid arthritis, ankylosing spondylitis, fracture, dislocation),
  • With cord compression and findings (L'hermitte sign is positive),
  • Having severe radiculopathy (Upper limb tension tests are positive),
  • Have osteoporosis,
  • It has been identified as having shoulder pain and any shoulder pathology (Rotator Cuff tear, shoulder impingement syndrome, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale Üniversitesi

Kırıkkale, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student (Graduate Student and Researcher)

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 26, 2021

Study Start

September 15, 2021

Primary Completion

March 30, 2022

Study Completion

April 30, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

We dont decide yet

Locations