Virtual Reality Program for Managing Chronic Neck Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHacettepe University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years

Diagnosis of chronic neck pain (≥ 6 months duration)

Ability to participate in rehabilitation sessions

Willingness to provide written informed consent

Disqualifiers

Previous adverse experience with virtual reality

Photophobia (UPSIS-12 score > 12)

Migraine (≥ 2 positive responses on ID-Migraine questionnaire)

Presence of any neurological deficit

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality Rehabilitation

    Other intervention

    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.

  • Conventional Rehabilitation

    Other intervention

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Virtual Reality Treatment GroupExperimental treatment 1 intervention
Group B: Conventional Therapy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline and at the end of the study.
2

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).

Time frame
Baseline and at the end of the study.
3

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.

Time frame
Baseline and at the end of the study.
4

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.

Time frame
Baseline and at the end of the study.

Secondary outcomes

1

Life Quality

Quality of life status will be measured using the Short Form-36 Health Survey (SF-36). Scores range from 0 (worst possible health status) to 100 (best possible health status). Higher scores indicate better health-related quality of life.

Time frame
Baseline and at the end of the study.
2

Kinesiophobia

Fear of movement will be assessed using the Tampa Scale of Kinesiophobia (TSK), a 17-item self-report questionnaire. Each item is scored from 1 to 4, yielding a total score range of 17 (no kinesiophobia) to 68 (maximum kinesiophobia). Higher scores indicate more severe kinesiophobia (worse outcome).

Time frame
Baseline and at the end of the study.
3

Treatment Adherence

Attendance at scheduled sessions will be recorded to determine adherence to the VR or conventional therapy program. Higher percentages reflect better adherence.

Time frame
At the end of the study.
4

Participant Satisfication

Perceived overall change will be evaluated using the Global Perceived Effect (GPE) Scale, a 7-point Likert-type scale assessing the participant's impression of improvement following the treatment program. Scores range from 1 (much worse) to 7 (much better), with 4 indicating no change. Higher scores indicate greater perceived improvement (better outcome).

Time frame
At the end of the study.

Other outcomes

Sponsors and contacts

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