CClinicalTrials.gg
Not yet recruitingNCT06549166Updated Aug 15, 2024

Virtual Reality in Chronic Neck Pain

An interventional study of Experimental: VR and exercise and Sham Comparator: exercise in Neck Pain, sponsored by Koç University. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Koç University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Neck Pain

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Keywords

  • virtual reality
  • exercise
  • neck pain
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In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's planned enrollment of 46 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Koç University is the lead sponsor of 106 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    VR and exercise

    virtual reality and neck exercises

    Other: Experimental: VR and exercise

  • Sham comparator
    exercise

    only neck exercise

    Other: Sham Comparator: exercise

Interventions

  • OtherExperimental: 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.

  • OtherSham Comparator: exercise

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

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What researchers measure

Primary outcomes

  1. Neck disability index

    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".

    Time frame: 8 weeks

Secondary outcomes

  1. Visual analog scale

    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.

    Time frame: 8 weeks

  2. Joint position sense error

    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.

    Time frame: 8 weeks

  3. Pressure pain threshold

    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.

    Time frame: 8 weeks

  4. joint range of motion

    Neck flexion, extension, right and left rotation, and right and left lateral flexion will be measured using the Cervical Range of Motion Device.

    Time frame: 8 weeks

  5. Bournemouth Neck Questionnaire

    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.

    Time frame: 8 weeks

  6. Tampa Scale for Kinesiophobia

    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.

    Time frame: 8 weeks

  7. Pittsburgh Sleep Quality Index

    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.

    Time frame: 8 weeks

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Study locations

1 site
  • Koc University School of Medicine
    Istanbul, 34010, Turkey
    • Yasemin Gursoy Ozdemir, Prof · Contact · ygursoy@ku.edu.tr · +908502508250
    • Ecenur Atli, PhD(c) · Principal investigator
    • Arzu Razak Ozdincler, Prof · Sub investigator
    • Ozden Ozyemisci Taskiran, Prof · Sub investigator
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References and documents

Publications

  • Ghamkhar L, Kahlaee AH. Are Ultrasonographic Measures of Cervical Flexor Muscles Correlated With Flexion Endurance in Chronic Neck Pain and Asymptomatic Participants? Am J Phys Med Rehabil. 2017 Dec;96(12):874-880. doi: 10.1097/PHM.0000000000000778. PubMed 28644248 ↗
  • Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1. Erratum In: J Orthop Sports Phys Ther. 2009 Apr;39(4):297. PubMed 18758050 ↗
  • Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180. PubMed 20436238 ↗
  • Tousignant M, Smeesters C, Breton AM, Breton E, Corriveau H. Criterion validity study of the cervical range of motion (CROM) device for rotational range of motion on healthy adults. J Orthop Sports Phys Ther. 2006 Apr;36(4):242-8. doi: 10.2519/jospt.2006.36.4.242. PubMed 16676874 ↗
  • Reddy RS, Meziat-Filho N, Ferreira AS, Tedla JS, Kandakurti PK, Kakaraparthi VN. Comparison of neck extensor muscle endurance and cervical proprioception between asymptomatic individuals and patients with chronic neck pain. J Bodyw Mov Ther. 2021 Apr;26:180-186. doi: 10.1016/j.jbmt.2020.12.040. Epub 2020 Dec 31. PubMed 33992242 ↗
  • Wibault J, Vaillant J, Vuillerme N, Dedering A, Peolsson A. Using the cervical range of motion (CROM) device to assess head repositioning accuracy in individuals with cervical radiculopathy in comparison to neck- healthy individuals. Man Ther. 2013 Oct;18(5):403-9. doi: 10.1016/j.math.2013.02.004. Epub 2013 Mar 7. PubMed 23473752 ↗
  • Clark P, Lavielle P, Martinez H. Learning from pain scales: patient perspective. J Rheumatol. 2003 Jul;30(7):1584-8. PubMed 12858463 ↗
  • Bolton JE, Humphreys BK. The Bournemouth Questionnaire: a short-form comprehensive outcome measure. II. Psychometric properties in neck pain patients. J Manipulative Physiol Ther. 2002 Mar-Apr;25(3):141-8. doi: 10.1067/mmt.2002.123333. PubMed 11986574 ↗
  • Ylinen J, Takala EP, Kautiainen H, Nykanen M, Hakkinen A, Pohjolainen T, Karppi SL, Airaksinen O. Effect of long-term neck muscle training on pressure pain threshold: a randomized controlled trial. Eur J Pain. 2005 Dec;9(6):673-81. doi: 10.1016/j.ejpain.2005.01.001. PubMed 16246820 ↗
  • Tejera DM, Beltran-Alacreu H, Cano-de-la-Cuerda R, Leon Hernandez JV, Martin-Pintado-Zugasti A, Calvo-Lobo C, Gil-Martinez A, Fernandez-Carnero J. Effects of Virtual Reality versus Exercise on Pain, Functional, Somatosensory and Psychosocial Outcomes in Patients with Non-specific Chronic Neck Pain: A Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Aug 16;17(16):5950. doi: 10.3390/ijerph17165950. PubMed 32824394 ↗
  • Hanney WJ, Kolber MJ, George SZ, Young I, Patel CK, Cleland JA. Development of a preliminary clinical prediction rule to identify patients with neck pain that may benefit from a standardized program of stretching and muscle performance exercise: a prospective cohort study. Int J Sports Phys Ther. 2013 Dec;8(6):756-76. PubMed 24377062 ↗
  • Peolsson A, Landen Ludvigsson M, Tigerfors AM, Peterson G. Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study. Arch Phys Med Rehabil. 2016 Feb;97(2):189-95. doi: 10.1016/j.apmr.2015.10.087. Epub 2015 Oct 26. PubMed 26514296 ↗
  • Falla D, Lindstrom R, Rechter L, Boudreau S, Petzke F. Effectiveness of an 8-week exercise programme on pain and specificity of neck muscle activity in patients with chronic neck pain: a randomized controlled study. Eur J Pain. 2013 Nov;17(10):1517-28. doi: 10.1002/j.1532-2149.2013.00321.x. Epub 2013 May 6. PubMed 23649799 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06549166
Lead sponsor
Koç University
Collaborators
Biruni University
Responsible party
Sponsor
First posted
Aug 12, 2024
Start date
Sep 2024 (estimated)
Primary completion
Jul 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 15, 2024

Study contacts

Yasemin Gursoy Ozdemir, Prof
Contact
ygursoy@ku.edu.tr
08502508250

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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