Virtual Reality in Chronic Neck Pain

August 13, 2024 updated by: Koç University

Effectiveness of Exercise Training and Virtual Reality on Disability, Pain and Joint Position Sense in Individuals With Chronic Neck Pain: A Randomized Controlled Study

The purpose of this study is to compare the effects of virtual reality, which encourages active neck movements, in individuals with chronic neck pain, with the control group receiving only neck exercises. Participants will be randomly divided into two groups; Half of them will be given only a neck exercises program, and the other half will be given neck exercises and virtual reality.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Individuals with chronic neck pain tend to have low levels of endurance in deep neck flexor muscles. Conservative treatments for neck pain, including posture education, strengthening, range of motion, motor control, flexibility, and proprioceptive training, are recommended in clinical guidelines. Virtual reality has been shown to be beneficial in the treatment of various issues related to pain in previous systematic reviews. Distracting attention is one of the mechanisms explaining the impact of virtual reality on pain. It is believed that virtual reality reduces pain perception by influencing pain pathways.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yasemin Gursoy Ozdemir, Prof
  • Phone Number: 08502508250
  • Email: ygursoy@ku.edu.tr

Study Locations

  • Turkey
      • Istanbul, Turkey, 34010
        • Koç University School of Medicine
        • Sub-Investigator:
          • Ozden Ozyemisci Taskiran, Prof
        • Contact:
        • Principal Investigator:
          • Ecenur Atli, PhD(c)
        • Sub-Investigator:
          • Arzu Razak Ozdincler, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages 18 to 45
  • Having a history of non-traumatic neck pain persisting for more than three months
  • Having a Neck Disability Index score greater than 5 points
  • Not having participated in a physiotherapy program for at least 3 months
  • Being able to read and write in Turkish to understand, interpret, and respond to the questionnaires

Exclusion Criteria:

  • Having a surgical history in the neck region
  • Having cervical spine flexion, extension, and rotation range of motion <10 degrees
  • Having a history of rheumatologic, vestibular, neurological, or cardiopulmonary diseases
  • Vertigo associated with neck pain
  • Osteoporosis, vertebral fractures,spinal tumors
  • Presence of radiculopathy or myelopathy
  • Traumatic spinal cord injury
  • Neck pain associated with progressive neurological deficits or loss of strength

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR and exercise
virtual reality and neck exercises
Other: Experimental: VR and exercise
Participants will perform a 20-minute exercise program consisting of neck joint mobility exercises, neck and scapulothoracic muscle strengthening exercises, and stretching exercises. Then, for the next 20 minutes, they will engage in active neck movements using the Oculus Quest2 headset with the Ocean Rift game.
Sham Comparator: exercise
only neck exercise
Other: Sham Comparator: exercise
The control group will perform a 40-minute same neck exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck disability index
Time Frame: 8 weeks
Neck disability index was used to determine the pain experience and functional disability of the participants. It consists of 10 questions concern of the pain severity, ability for personal care, lifting weight, job capability headache intensity, concentration, quality of sleeping and driving and recreation activities. Total score ranges between 0 to 50 points. Zero to four points mean "no disability", 5 to 14 points mean "light disability", 15 to 24 points mean "moderate disability", 25 to 34 points mean "severe disability", and 35 to 50 points mean "complete disability".
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint position sense error
Time Frame: 8 weeks
The sense of joint position error will be measured using the Cervical Range of Motion Device. The individual's head will be passively brought to 50% of the joint's range of motion, and the individual will be asked to wait for three seconds to feel the position. Then, the individual will be asked to bring their head to that position with their eyes closed. This process will be repeated three times for all directions.
8 weeks
Pressure pain threshold
Time Frame: 8 weeks
A pressure algometer with a round tip measuring 1 cm² surface area will be used to assess pressure pain threshold. The sternum will be used as a reference point, and the trapezius and levator scapula muscles will be evaluated. The tip of the algometer probe will be applied to the skin perpendicular to it at a rate of 1 kg/cm² per second. The patient will be asked to indicate when the pressure sensation turns into pain. There will be a 30-second rest period between measurements, and bilateral evaluation will be performed, starting with the right side followed by the left side.
8 weeks
joint range of motion
Time Frame: 8 weeks
Neck flexion, extension, right and left rotation, and right and left lateral flexion will be measured using the Cervical Range of Motion Device.
8 weeks
Bournemouth Neck Questionnaire
Time Frame: 8 weeks
The Bournemouth Neck Questionnaire, individuals rank the following 7 dimensions of pain and function on a scale of 0 to 10: pain severity, physical disability, social disability, anxiety, depression, employment, and ability to control their pain.
8 weeks
Tampa Scale for Kinesiophobia
Time Frame: 8 weeks
The Tampa Scale of Kinesiophobia was used to measure the kinesiophobia related to the pain. It is a scale with 17 items, and the scores range from 17 to 68. The higher the score is, the greater the kinesiophobia.
8 weeks
Pittsburgh Sleep Quality Index
Time Frame: 8 weeks
The Pittsburgh Sleep Quality Index is a self-report assessment tool that evaluates sleep quality over a one-month period. A global score and seven component scores can be derived from the scale. The component scores are the following: Subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. Each component is scored on a scale from 0-3, with the total score ranging from 0-21; where a higher score describes poorer sleep quality.
8 weeks
Visual analog scale
Time Frame: 8 weeks
Visual analog scale is a self-reported scale consisting of a horizontal line (10 cm long) with anchor points of zero for "no pain" and ten for "worst possible pain." The patient was asked to put a mark on the line that best described the severity of his or her pain between zero and ten.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Collaborators

Biruni University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.311.IRB1.107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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