Virtual Reality in Chronic Neck Pain

NCT06549166 | Not Yet Recruiting

• 1 other identifier: 2023.311.IRB1.107
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain

Keywords

virtual reality; exercise; neck pain

Outcome Measures

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".

  8 weeks

Secondary Outcomes (7)

• Visual analog scale

  8 weeks

• Joint position sense error

  8 weeks

• Pressure pain threshold

  8 weeks

• joint range of motion

  8 weeks

• Bournemouth Neck Questionnaire

  8 weeks

Study Arms (2)

VR and exercise

EXPERIMENTAL

virtual reality and neck exercises

Other: Experimental: VR and exercise

exercise

SHAM COMPARATOR

only neck exercise

Other: Sham Comparator: exercise

Interventions

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.

VR and exercise

Sham Comparator: exercise OTHER

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

exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead
• Biruni University: collaborator

Study Sites (1)

Koc University School of Medicine

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  PMID: 28644248 BACKGROUND

• 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.

  PMID: 18758050 BACKGROUND

• 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.

  PMID: 20436238 BACKGROUND

• 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.

  PMID: 16676874 BACKGROUND

• 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.

  PMID: 33992242 BACKGROUND

• 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.

  PMID: 23473752 BACKGROUND

• Clark P, Lavielle P, Martinez H. Learning from pain scales: patient perspective. J Rheumatol. 2003 Jul;30(7):1584-8.

  PMID: 12858463 BACKGROUND

• 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.

  PMID: 11986574 BACKGROUND

• 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.

  PMID: 16246820 BACKGROUND

• 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.

  PMID: 32824394 BACKGROUND

• 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.

  PMID: 24377062 BACKGROUND

• 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.

  PMID: 26514296 BACKGROUND

• 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.

  PMID: 23649799 BACKGROUND

MeSH Terms

Conditions

Neck Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yasemin Gursoy Ozdemir, Prof

CONTACT

08502508250; ygursoy@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)