NCT06397157

Brief Summary

Non-specific neck pain is the most common musculoskeletal symptom which can cause limited cervical mobility, impaired functional status and stress at work. Virtual reality and motor imagery are unique technologies which have beneficial effects on the treatment of non-specific neck pain. Virtual reality is a simulated 3D environment that enables users to explore and interact with a virtual surrounding while motor imagery (MI) is a dynamic mental process of an action, without its actual motor execution. This study aims to investigate the combined effects of Virtual Reality (VR) and Motor Imagery Techniques (MI) with Routine Physical Therapy (RPT) in patients with Non-specific neck pain. This randomized clinical trial will be carried at Railway General Hospital, Rawalpindi on 93 participants meeting the inclusion criteria included in the study through probability convenience sampling technique. 3 groups of participants assigned ramdomly will receive interventions for three days a week for 6 weeks. Group A will receive virtual reality (VR) and motor imagery (MI) along with routine physical therapy for . Group B participants will receive VR along with routine physical therapy while Group C will receive MI along with routine physical therapy. Total treatment time will be 40 minutes. Outcome measure tools will be Numeric pain rating scale to measure pain, the Tampa scale of Kinesiophobia (TSK) for the measurement of kinesiophobia and Neck disability index for disability and functional status.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

December 10, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

April 29, 2024

Last Update Submit

June 11, 2024

Conditions

Keywords

Cervical painKinesiophobiaPainMotor ImageryVirtual Reality

Outcome Measures

Primary Outcomes (3)

  • Numerical Pain Rating Scale (NPRS)

    In a Numerical Pain Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents no pain at all whereas the upper limit represents 'the worst pain ever possible'. Numerical Pain Rating Scales have shown high correlations with other pain-assessment tools in several studies.

    6 weeks

  • The Tampa Scale for Kinesiophobia (TSK)

    The Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that quantifies fear of movement. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible Kinesiophobia, and the higher scores indicate an increasing degree of Kinesiophobia.

    6 weeks

  • Neck Disability Index (NDI)

    A modification of the Oswestry Low Back Pain Index was conducted producing a 10-item scaled questionnaire entitled the Neck Disability Index (NDI) for the measurement of disability and functional status. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst.

    6 weeks

Study Arms (3)

Virtual Reality+Motor Imagery+Routine physical therapy

EXPERIMENTAL

Participants in Group A will receive Virtual Reality (VR) and Motor Imagery (MI) training with Routine physical therapy for every alternate day (3 days per week) for 6 weeks. Total number of sessions will be 18.

Other: Virtual RealityOther: Motor ImageryOther: Routine Physical therapy

Virtual Reality+Routine physical therapy

ACTIVE COMPARATOR

Participants in Group A will receive Virtual Reality (VR) training with Routine physical therapy for every alternate day (3 days per week) for 6 weeks. Total number of sessions will be 18.

Other: Virtual RealityOther: Routine Physical therapy

Motor Imagery+ Routine physical therapy

ACTIVE COMPARATOR

Participants in Group A will receive Motor Imagery(MR) training with Routine physical therapy for every alternate day (3 days per week) for 6 weeks. Total number of sessions will be 18.

Other: Motor ImageryOther: Routine Physical therapy

Interventions

Participants will recieve treatment(Virtual reality) for every alternate day (3 days per week) for 6 weeks. Total number of sessions will be 18.

Virtual Reality+Motor Imagery+Routine physical therapyVirtual Reality+Routine physical therapy

Participants will recieve treatment(Motor Imagery) for every alternate day (3 days per week) for 6 weeks. Total number of sessions will be 18.

Motor Imagery+ Routine physical therapyVirtual Reality+Motor Imagery+Routine physical therapy

Participants will recieve treatment(Routine physical therapy) for every alternate day (3 days per week) for 6 weeks. Total number of sessions will be 18.

Motor Imagery+ Routine physical therapyVirtual Reality+Motor Imagery+Routine physical therapyVirtual Reality+Routine physical therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age of the patients should be 18-50 years
  • Both females and males are included
  • Patient should have a consistent pain for 3 months or more.
  • Patient having non-specific neck pain.

You may not qualify if:

  • Specific neck pain caused by metastasis, neoplasia, infectious or inflammatory disorders, bone fractures or traumatic precedents with neck injuries (2)
  • Positive neurological signs or evidence of spinal compression (abnormal diffuse sensitivity, hyperreflexia, or diffuse weakness)
  • Cervical osteoarthritis
  • Spondylarthritis
  • Neck pain associated with vertigo (vestibular involvement)
  • Neck pain associated with whiplash injuries
  • Previous cervical surgeries (2)
  • Headaches before the onset of neck pain and without cervical origin
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital ,Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (5)

  • Kragting M, Voogt L, Coppieters MW, Pool-Goudzwaard AL. Visual feedback manipulation in virtual reality to influence pain-free range of motion. Are people with non-specific neck pain who are fearful of movement more susceptible? PLoS One. 2023 Jul 5;18(7):e0287907. doi: 10.1371/journal.pone.0287907. eCollection 2023.

    PMID: 37406021BACKGROUND
  • 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: 32824394BACKGROUND
  • Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

    PMID: 1834753BACKGROUND
  • Kortlever JTP, Tripathi S, Ring D, McDonald J, Smoot B, Laverty D. Tampa Scale for Kinesiophobia Short Form and Lower Extremity Specific Limitations. Arch Bone Jt Surg. 2020 Sep;8(5):581-588. doi: 10.22038/abjs.2020.40004.2073.

    PMID: 33088859BACKGROUND
  • Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

    PMID: 16320034BACKGROUND

MeSH Terms

Conditions

Neck PainKinesiophobiaPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Sabiha Arshad, M phil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

December 10, 2023

Primary Completion

June 10, 2024

Study Completion

July 10, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations