Additional Benefits of Virtual Reality Therapy for Individuals With Neck Pain

Neck Pain Clinical Trial

Official title:

Does Adding Virtual Reality Therapy to Conventional Physical Therapy Improve Clinical Outcomes in Individuals With Chronic Neck Pain?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06235515
• Other study ID #: AEÜ-NK-SG
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: January 2024
• Source: Kirsehir Ahi Evran Universitesi
• Contact: Nazife KAPAN, Asst. Prof.
• Phone: 03862803924
• Email: nazifekapan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to investigate the effect of adding virtual reality therapy to conventional treatment in patients with chronic neck pain on pain, neck disability index, kinesiophobia, insomnia severity questionnaire, hospital anxiety depression scale, cervical range of motion and pressure pain threshold.

Description:

Neck pain is a disease that affects individuals and society worldwide. Between 50% and 85% of the general population experiences neck pain at some point in their lives, and every person who experiences neck pain is likely to experience pain again after 1-5 years. Neck pain is considered chronic if it lasts more than 3 months. Passive and active physical therapy approaches play a very important role in the treatment of neck pain. With the rapid development of technology, new developments such as virtual reality have begun to be used in the treatment of chronic neck pain. Virtual reality (VR) is a term describing innovative, real-time, computer-based technologies that play an increasing role for many patient groups in the field of physical medicine and rehabilitation. Virtual reality has been shown to be effective in reducing pain and discomfort in patients with different types of chronic pain. Motivation and interaction are the main practical benefits of virtual reality training, especially in video game-based therapy approaches, unlike traditional rehabilitation. Patients play the therapeutic game over and over again to achieve a better score without getting bored. Feedback, an important component of motor learning, is a prominent feature in virtual environments.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-65 who signed the informed consent form
• Those with existing neck pain
• Those whose neck pain continues for at least 12 weeks

Exclusion Criteria:

• Previous cervical surgery
• Having received FTR from the cervical region in the last 6 months
• Having had a spinal fracture
• History of malignancy
• Those with pacemakers
• Those with rheumatological, vestibular and neurological diseases
• Pregnant women

Related Conditions & MeSH terms

• Neck Pain
• Rehabilitation
• Virtual Reality

Intervention

Other:
• rehabilitation program
conventional treatment (hotpack and TENS and exercise)
• virtual reality
virtual reality treatment

Locations

Country	Name	City	State
Turkey	Kirsehir Ahi Evran University	Kirsehir

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Adamovich SV, Fluet GG, Tunik E, Merians AS. Sensorimotor training in virtual reality: a review. NeuroRehabilitation. 2009;25(1):29-44. doi: 10.3233/NRE-2009-0497. — View Citation

Ahern MM, Dean LV, Stoddard CC, Agrawal A, Kim K, Cook CE, Narciso Garcia A. The Effectiveness of Virtual Reality in Patients With Spinal Pain: A Systematic Review and Meta-Analysis. Pain Pract. 2020 Jul;20(6):656-675. doi: 10.1111/papr.12885. Epub 2020 May 21. — View Citation

Burdea GC. Virtual rehabilitation--benefits and challenges. Methods Inf Med. 2003;42(5):519-23. — View Citation

Haldeman S, Carroll L, Cassidy JD. Findings from the bone and joint decade 2000 to 2010 task force on neck pain and its associated disorders. J Occup Environ Med. 2010 Apr;52(4):424-7. doi: 10.1097/JOM.0b013e3181d44f3b. — View Citation

Holden MK. Virtual environments for motor rehabilitation: review. Cyberpsychol Behav. 2005 Jun;8(3):187-211; discussion 212-9. doi: 10.1089/cpb.2005.8.187. — View Citation

Vernon HT, Humphreys BK, Hagino CA. A systematic review of conservative treatments for acute neck pain not due to whiplash. J Manipulative Physiol Ther. 2005 Jul-Aug;28(6):443-8. doi: 10.1016/j.jmpt.2005.06.011. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Anolog Scale	It is a pain rating scale with numbers 0 and 10. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale. Patients' night, rest and activity pain will be evaluated separately.	Before treatment and three weeks
Primary	Neck Disability Index	It is the most widely used scale for cervical dysfunction and pain. It is also a unidimensional measurement used to determine the patient's perceived level of disability due to neck pain. It is a personal questionnaire consisting of 10 items regarding daily living activities. Each section is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no injury) to 50 (total injury).	Before treatment and three weeks
Primary	Range of Motion	Cervical range of motion, flexion, extension, right-left lateral flexion and right-left rotations will be measured and recorded using a goniometer. Normal joint ranges of motion; Flexion was determined as 50 degrees, extension as 70 degrees, lateral flexion as 45 degrees and rotation as 80 degrees.	Before treatment and three weeks
Secondary	Tampa Kinesiophobia Scale	It consists of 17 questions designed to measure fear of movement. A 4-point Likert scoring (1: strongly disagree, 2: disagree, 3: agree, 4: completely agree) is used. Total score varies between 17-68. It is concluded that the higher the person scores on the scale, the higher the fear of movement.	Before treatment and three weeks
Secondary	Insomnia Severity Index	This scale, developed to determine the degree of insomnia symptoms, can be used in normal population screening and clinical evaluation of insomnia. It is a five-point Likert type scale consisting of seven items. 0-7 points indicate insignificant insomnia, 8-14 indicates clinically subthreshold insomnia, 15-21 indicates moderate insomnia, and 22-28 indicates severe insomnia.	Before treatment and three weeks
Secondary	Hospital Anxiety Depression Scale	This scale was used to determine anxiety and depression symptomatology. The scale consists of a total of 14 items, 7 items assessing depression and 7 items assessing anxiety. By summing the subscale scores, 0-21 points can be obtained from each of the depression and anxiety scales. 0-7 points; no depression or anxiety disorder, 8-10 points; mild depression or anxiety disorder, 11-14 points; moderate, 15-21 points; indicates severe disorder.	Before treatment and three weeks
Secondary	Pressure Pain Threshold	A pressure algometer (Baseline dolorimeter-66 pound sensitivity- with circular probe) will be used to evaluate the pressure pain threshold. Pain pressure thresholds will be measured from both the right and left upper trapezius and the right-left C1/2 and C5/6 articular pilar level. Before measurements are taken at these points, the pressure pain threshold measurement will be displayed on the patient's hand in order to familiarize the patient with the procedure. Participants will be told to say 'stop' when the feeling changes from pressure to pain. Three measurements will be made at each point with a 1 cm diameter probe and a maximum pressure of up to 60 N will be applied at a speed of approximately 3 N/s. A 30-second rest period will be left between each measurement and the average of the measurements will be recorded.	Before treatment and three weeks