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Neck PainNCT06549166

Virtual Reality in Chronic Neck Pain

A study testing Experimental: VR and exercise in people with Neck Pain, run by Koç University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Neck Pain
What is being tested?
Experimental: VR and exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteTurkey (Türkiye)
Study dates
Sep 2024to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Yasemin Gursoy Ozdemir, Prof contact

08502508250

ygursoy@ku.edu.tr

Turkey (Türkiye)1 site

  • Koc University School of Medicine

    Istanbul, 34010

    Yasemin Gursoy Ozdemir, Prof, +908502508250, ygursoy@ku.edu.tr

    Ecenur Atli, PhD(c)

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Conditions
Neck Pain
Being tested
Experimental: VR and exercise, Sham Comparator: exercise
Keywords
virtual reality, exercise, neck pain
Medical subject headings
Neck Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: VR and exerciseOther

    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: exerciseOther

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

Study groups in NCT06549166
Study groupRoleWhat they receive
VR and exerciseExperimentalvirtual reality and neck exercises
Receives: Other: Experimental: VR and exercise
exerciseSham comparatoronly neck exercise
Receives: Other: Sham Comparator: exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 8 weeks

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study startSep 2024 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06549166
Sponsor's protocol ID
2023.311.IRB1.107
Status last verified
Aug 2024
First submitted
8 Aug 2024
Last updated
15 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: VR and exercise in people with Neck Pain, run by Koç University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yasemin Gursoy Ozdemir, Prof (08502508250, ygursoy@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck disability index (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06549166, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.

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Virtual Reality in Chronic Neck Pain (NCT06549166) | AzTrials