NCT07189052

Brief Summary

The goal of this clinical trial is to find out if a virtual reality-based rehabilitation program developed by our team can help people with chronic neck pain. The main questions it aims to answer are:

  • Does the VR program reduce neck pain?
  • Does it improve daily function and quality of life? Participants will:
  • Take part in a supervised virtual reality exercise program for 8 weeks, attending 3 sessions per week (24 sessions in total).
  • Each session will last about 45 minutes.
  • Complete tests and questionnaires about their pain, disability, and overall well-being before and after the program.

Trial Health

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Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Oct 2025

Typical duration for not_applicable

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

Study Progress27%
Oct 2025Oct 2027

First Submitted

Initial submission to the registry

September 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 25, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2027

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2027

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 16, 2025

Last Update Submit

September 24, 2025

Conditions

Keywords

virtual realityserious gamingchronicneckpainrehabilitationconventionaltechnologic

Outcome Measures

Primary Outcomes (4)

  • Pain Intensity

    Pain severity will be measured using the Visual Analog Scale (VAS), a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain), where participants indicate their average neck pain intensity over the past week. Higher scores represent greater pain (worse outcome).

    Baseline and at the end of the study.

  • Neck Disability

    Functional disability will be evaluated using the Neck Disability Index (NDI), a 10-item self-report questionnaire assessing daily activities affected by neck pain. Each item is scored from 0 to 5, yielding a total score range of 0 (no disability) to 50 (maximum disability). Higher scores indicate greater disability (worse outcome).

    Baseline and at the end of the study.

  • Cervical Range of Motion

    Cervical range of motion (flexion, extension, right/left lateral flexion, and right/left rotation) will be measured using the CROM device. Higher values indicate greater mobility.

    Baseline and at the end of the study.

  • Proprioception

    Proprioceptive accuracy will be assessed by measuring joint position sense error in degrees using the CROM device. Higher error values indicate poorer position sense.

    Baseline and at the end of the study.

Secondary Outcomes (4)

  • Life Quality

    Baseline and at the end of the study.

  • Kinesiophobia

    Baseline and at the end of the study.

  • Treatment Adherence

    At the end of the study.

  • Participant Satisfication

    At the end of the study.

Study Arms (2)

Virtual Reality Treatment Group

EXPERIMENTAL

Participants in this group will receive a virtual reality-based rehabilitation program developed by the investigators for individuals with chronic neck pain. The program includes four structured components: (1) diaphragmatic breathing with guided head movements in a seaside setting; (2) stretching performed through avatar-controlled jet-ski tasks to collect targets; (3) cervical range-of-motion exercises covering flexion, extension, lateral flexion, and rotation; and (4) posture-strengthening tasks to promote scapular and postural control. All exercises correspond to conventional therapy content but are delivered as immersive, game-adapted tasks. The program will be delivered for 8 weeks, 2 sessions per week (16 sessions total), each lasting about 20 minutes.

Other: Virtual Reality Rehabilitation

Conventional Therapy Group

ACTIVE COMPARATOR

Participants in this group will receive a therapist-guided physiotherapy program for chronic neck pain. The program includes: (1) diaphragmatic breathing, 10 repetitions; (2) trapezius stretching (right and left), 10 repetitions of 15 seconds each; (3) cervical range-of-motion exercises (flexion, extension, lateral flexion, rotation), 10 repetitions of 5 seconds each; and (4) posture-strengthening with proprioceptive neuromuscular facilitation for scapular retraction, 3 sets of 10 repetitions. The program will be delivered for 8 weeks, 2 sessions per week (16 sessions total), each lasting about 20 minutes.

Other: Conventional Rehabilitation

Interventions

A virtual reality-based rehabilitation program including breathing, stretching, cervical range-of-motion, and posture-strengthening tasks delivered in a gamified seaside environment using a head-mounted VR display. Sessions will last 20 minutes, performed twice per week for 8 weeks (16 sessions total) under supervision.

Virtual Reality Treatment Group

Standard physiotherapy including diaphragmatic breathing, trapezius stretching, cervical range-of-motion, and posture-strengthening with proprioceptive neuromuscular facilitation. Sessions will last 20 minutes, performed twice per week for 8 weeks (16 sessions total) under supervision.

Conventional Therapy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • Diagnosis of chronic neck pain (≥ 6 months duration)
  • Ability to participate in rehabilitation sessions
  • Willingness to provide written informed consent

You may not qualify if:

  • Previous adverse experience with virtual reality
  • Photophobia (UPSIS-12 score \> 12)
  • Migraine (≥ 2 positive responses on ID-Migraine questionnaire)
  • Presence of any neurological deficit
  • History of spinal surgery
  • Medical conditions interfering with participation, including orthopedic, inflammatory, cardiovascular, rheumatologic, or vestibular disorders
  • Pregnancy
  • Epilepsy or other neurological conditions causing photosensitivity
  • Congenital spinal cord malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Department of neurosurgery

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (1)

  • Ruf M, Welk T, Muller M, Merk HR, Harms J. Ventral cancellous bone augmentation of the dens and temporary instrumentation C1/C2 as a function-preserving option in the treatment of dens pseudarthrosis. J Spinal Disord Tech. 2010 Jun;23(4):285-92. doi: 10.1097/BSD.0b013e3181aac6ff.

    PMID: 20110831BACKGROUND

MeSH Terms

Conditions

Bronchiolitis Obliterans SyndromePain

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two groups: (1) virtual reality-based rehabilitation or (2) conventional therapy. Both groups will complete the same categories of therapeutic exercises (breathing, stretching, cervical range-of-motion, and posture-strengthening), but the VR group performs a gamified version in an immersive virtual environment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hatice Çeitn, Asst.Prof.

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 23, 2025

Study Start

October 25, 2025

Primary Completion (Estimated)

October 25, 2027

Study Completion (Estimated)

October 28, 2027

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

There are no plans to share individual participant data (IPD) because of privacy and confidentiality concerns.

Locations