NCT06235515

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

January 8, 2024

Last Update Submit

September 16, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Tampa Kinesiophobia Scale

    Before treatment and three weeks

  • Insomnia Severity Index

    Before treatment and three weeks

  • Hospital Anxiety Depression Scale

    Before treatment and three weeks

  • Pressure Pain Threshold

    Before treatment and three weeks

Study Arms (2)

group I

EXPERIMENTAL

conventional treatment As conventional treatment, patients will receive 20 minutes of hotpack and 20 minutes of TENS, 5 sessions a week for a total of 15 sessions for 3 weeks. Additionally, patients will be given cervical isometric exercises as a home exercise program.

Other: rehabilitation program

group II

EXPERIMENTAL

conventional treatment and virtual reality As conventional treatment, patients will receive 20 minutes of hotpack and 20 minutes of TENS, 5 sessions a week for a total of 15 sessions for 3 weeks. Additionally, patients will be given cervical isometric exercises as a home exercise program. In addition to conventional treatment, virtual reality treatment will allow patients to play games in which they can perform neck movements in all directions for 30 minutes a day, 5 sessions a week for 3 weeks..

Other: rehabilitation programOther: virtual reality

Interventions

conventional treatment (hotpack and TENS and exercise)

group Igroup II

virtual reality treatment

group II

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 20357682BACKGROUND
  • 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.

    PMID: 16096044BACKGROUND
  • 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.

    PMID: 32196892BACKGROUND
  • 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.

    PMID: 19713617BACKGROUND
  • Burdea GC. Virtual rehabilitation--benefits and challenges. Methods Inf Med. 2003;42(5):519-23.

    PMID: 14654886BACKGROUND
  • 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.

    PMID: 15971970BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

January 8, 2024

First Posted

February 1, 2024

Study Start

March 15, 2024

Primary Completion

September 16, 2024

Study Completion

September 16, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations