NCT06802601

Brief Summary

The aim of the study was to improve pain, function, balance and reaction times in people with chronic neck pain by stimulating and improving the components that provide input to the central nervous system (proprioceptive, visual, vestibular) through manual therapy and exercise and to reveal the results of vizio-vestibular training applied in addition to manual therapy and exercise. Therefore, the hypotheses of this study were; H1: Manual therapy and exercise have a positive effect on pain, function, balance and reaction time in people with chronic neck pain. H2: Vizio-vestibular exercises given in addition to manual therapy and exercise have a positive effect on pain, function, balance and reaction time in people with chronic neck pain. H3: There is no difference between the effects of manual therapy and exercise and viziovestibular exercises in addition to manual therapy and exercise on pain, function, balance and reaction time in people with chronic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

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

October 28, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

January 16, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Manual TherapyNeck Pain

Outcome Measures

Primary Outcomes (3)

  • Pain

    Pain intensity will be questioned with the Visual Analog Scale. The Visual Analog Scale pain assessment scale was first used by Hayes and Patterson in 1921. It measures the severity of pain based on the patient's statement. A straight thin 10 cm line is used. 0 is defined as "no pain" and 10 as "unbearable pain". The patient is asked to mark the point on the line describing the pain. The length of the distance indicates the severity of the patient's pain.

    From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  • Cervical Range of Motion

    Goniometric measurement is used in the clinic as an objective measurement tool for the assessment of active range of motion. Goniometer is a durable, simple, easy-to-carry device that can be easily used in almost all joints. Neck flexion, extension, lateral flexion and rotation movements will be evaluated with goniometer.

    From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  • Function

    The Neck and Neck Disability Index will be used to assess the level of function in people with neck pain. The questionnaire, whose Turkish validity and reliability study was conducted by Aslan et al. consists of 10 items. Each item is scored from 0 (no disability) to 5 (complete disability). The total score is between 0 (no disability) and 50 (total disability). Disability increases with increasing score and decreases with decreasing score.

    From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

Secondary Outcomes (6)

  • Pressure Pain Threshold

    From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  • Balance

    From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  • Reaction Time

    From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  • The Cervical Flexor Endurance Test

    From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  • Cervical Extensor Endurance Test

    From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  • +1 more secondary outcomes

Study Arms (2)

Manuel Therapy and Stabilization Exercises

ACTIVE COMPARATOR
Other: Manual Therapy and Exercise

Manuel Therapy and Stabilization Exercises plus Visio-Vestibular Exercises

EXPERIMENTAL
Other: Manual Therapy, Exercise and Visio-Vestibular Exercise

Interventions

Manual Therapy and Exercise

Manuel Therapy and Stabilization Exercises

Manual Therapy, Exercise and Visio-Vestibular Exercise

Manuel Therapy and Stabilization Exercises plus Visio-Vestibular Exercises

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Be between the ages of 18 and 55
  • Complaining of neck pain for at least 3 months or experiencing neck pain at least 2 times in 3 months
  • Volunteering for the study
  • To be able to read and understand Turkish

You may not qualify if:

  • Previous history of neck and head trauma or surgery
  • Vertigo or dizziness caused by known or suspected vestibular pathology, ear or brain disorders, sensory nerve pathways (e.g. BPPV) or vascular disorders (e.g. migraine, hypertension)
  • Any musculoskeletal or neurological condition that may affect balance
  • Inflammatory joint disease
  • Cognitive impairment
  • Taking four or more medicines
  • Received physiotherapy treatment for neck pain in the last 12 months
  • People with strabismus, lazy eye and severe refractive errors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi Univeristy

Izmir, Cigli, Turkey (Türkiye)

Location

Related Publications (2)

  • Guitton D, Kearney RE, Wereley N, Peterson BW. Visual, vestibular and voluntary contributions to human head stabilization. Exp Brain Res. 1986;64(1):59-69. doi: 10.1007/BF00238201.

    PMID: 3490396BACKGROUND
  • Kristjansson E, Treleaven J. Sensorimotor function and dizziness in neck pain: implications for assessment and management. J Orthop Sports Phys Ther. 2009 May;39(5):364-77. doi: 10.2519/jospt.2009.2834.

    PMID: 19411769BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal ManipulationsExercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pt, MSc

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 31, 2025

Study Start

October 28, 2024

Primary Completion

May 21, 2025

Study Completion

June 1, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations