Clinical trial NCT06397157: Combined Effects of Virtual Reality and Motor Imagery in Patients With Non-specific Neck Pain
Official title: Combined Effects of Virtual Reality and Motor Imagery With Routine Physical Therapy in Patients With Non-specific Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Pain
Kinesiophobia
Pain
Keywords: Cervical pain
Kinesiophobia
Pain
Motor Imagery
Virtual Reality
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Non-specific neck pain is the most common musculoskeletal symptom which can cause limited cervical mobility, impaired functional status and stress at work. Despite of the duration, neck pain can impair functional capacity, quality of life and can cause worry, anxiety and depression. 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 ,Rawalpinidi .93 participants meeting the inclusion criteria will be included in this study through a non-probability convenience sampling technique.

Participants will be randomly assigned into 3 groups using computer generated method. All the groups 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. The data will be collected at baseline before the treatment of the patient, Follow-up on the 3rd week and post treatment measure on the 6th week to measure the outcome measures. Data will be analysed by SPSS version 26. Statistical significance will be set at p=0.05. The normality of data will be checked by using Kolmogorov- Smirnov test. For the between group analysis of parametric data, one way ANOVA will be used, while Kruskal-Wallis test will be applied for non-parametric data. For within group comparison repeated measure ANOVA will be applied for parametric data, for non-parametric data Friedman ANOVA will be applied.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 6 weeks
measure: The Tampa Scale for Kinesiophobia (TSK)
timeFrame: 6 weeks
measure: Neck Disability Index (NDI)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital ,Rawalpindi
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad, M phil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
citation: 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.
citation: 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.