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NCT Number: NCT06549166

Virtual Reality in Chronic Neck Pain

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koc University School of Medicine

Istanbul, 34010, Turkey (Türkiye)

Location contact

Arzu Razak Ozdincler, Prof

SUB_INVESTIGATOR

Ecenur Atli, PhD(c)

PRINCIPAL_INVESTIGATOR

Ozden Ozyemisci Taskiran, Prof

SUB_INVESTIGATOR

Yasemin Gursoy Ozdemir, Prof

CONTACT

[email protected]

+908502508250

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: VR and exercise

Other

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

Other

The control group will perform a 40-minute same neck exercises.

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yasemin Gursoy Ozdemir, Prof

CONTACT

[email protected]

08502508250

Sponsors and collaborators

Lead sponsor

Koç University

Other

Collaborators

  • Biruni University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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