IRCT | The effects of exercise therapy with VR on sensory, psychosocial symptoms, and electromyographic activity of trunk muscles during functional tasks in chronic low back pain patients with high central sensitization.

Protocol summary

Study aim: This study focuses on central sensitization in back pain and evaluates virtual reality (VR) as a potential therapeutic approach.
Design: In this single-blind randomized clinical trial, patients are enrolled in the study based on the central sensitivity questionnaire and are first evaluated in two groups. Then, the group of patients with high central sensitivity undergoes intervention with virtual reality exercises for four weeks.
Settings and conduct: The study will be conducted as a randomized clinical trial, and eligible patients will be enrolled after screening and randomly assigned to intervention and control. The interventions will then be implemented during specific sessions, and variables such as pain intensity, disability, central sensitivity indices, and motor function will be assessed before and after the intervention.
Participants/Inclusion and exclusion criteria: Include: age 18–60, chronic low back pain, moderate pain, high central sensitization, normal cognition, and sensation. Exclude: disc/nerve pathology, systemic disease, pregnancy, high BMI, sensory or balance disorders, noncompliance, or inability to exercise.
Intervention groups: Subjects perform 30–45 minutes of Xbox 360 Kinect game-exercise with no prior Kinect use or professional intense exercise history. Each session includes 10 minutes of warm-up and 5 minutes of cool-down stretching. Exercise is done 3 m from the Kinect and a 48-inch monitor, with chair rest allowed if needed. Intensity is kept at 64–76% HRmax via fingertip monitoring. Games are selected from Kinect Adventures, and difficulty is adjusted by time or repetitions based on pilot results
Main outcome variables: Pain severity, psychosocial symptoms, degree of functional disability, central sensitization, motorfunction

General information

Reason for update
Acronym: CS (Central ensitization)
IRCT registration information: IRCT registration number: IRCT20090203001637N14

Registration date: 2026-02-11, 1404/11/22

Registration timing: prospective

Last update: 2026-02-11, 1404/11/22

Update count: 0
Registration date: 2026-02-11, 1404/11/22

Registrant information: Name

Sedighe Kahrizi

Name of organization / entity

Tarbiat Modares University

Country

Iran (Islamic Republic of)

Phone

+98 21 8288 4511

Email address

kahrizis@modares.ac.ir

Recruitment status: recruiting
Funding source

Expected recruitment start date: 2026-04-11, 1405/01/22
Expected recruitment end date: 2027-09-06, 1406/06/15
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effects of exercise therapy with VR on sensory, psychosocial symptoms, and electromyographic activity of trunk muscles during functional tasks in chronic low back pain patients with high central sensitization.

Public title: The effect of virtual reality exercise therapy in the treatment of chronic low back pain patients with high central sensitization.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

History of low back pain for at least 3 months as defined by the US National Institutes of Health as non-specific low back pain. Having an average pain intensity between 3 and 7 at the time of study entry Having a score of 40 or higher on the Central Sensitivity Questionnaire No pain medication for 48 hours prior to assessment and intervention. No abnormalities in skin sensation. Scoring above 23 on the Mini-Mental State Examination (MMSE).

Exclusion criteria:

Having intervertebral disc problems and nerve involvement (such as disc herniation, spondylosis, spondylolisthesis, and radiculopathy) and a history of any related surgery History of cardiovascular, respiratory, rheumatic, neurological, malignancy, and infection diseases Pain intensity higher than 7 and lower than 3 based on VAS on the day of the test Pregnancy Body mass index (BMI) higher than 25 kilograms per square meter Vision and hearing impairment Having a confirmed disorder of the vestibular and balance system Unwillingness to continue cooperation Inability to learn and correctly execute an exercise program Missing the inclusion criteria for the treatment period
Age: From 18 years old to 60 years old
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor

Sample size

Target sample size: 22

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization will be performed using sealed, numbered envelopes, each containing the group allocation. Participants will receive an envelope upon enrollment, ensuring allocation concealment and minimizing selection bias.

Blinding (investigator's opinion)

Single blinded

Blinding description

To prevent assessment bias, evaluators will be blinded to the patients' group allocation (intervention or control).

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Tarbiat modares University

Street address

Tehran, Jalal Al-Ahmad, Nasr Crossing, Tarbiat Modares University

City

Tehran

Province

Tehran

Postal code

1411713116
Approval date: 2025-11-01, 1404/08/10
Ethics committee reference number: IR.MODARES.REC.1404.136

Health conditions studied

1

Description of health condition studied: non-specific low back pain (LBP) with high levels of central sensitization
ICD-10 code: central se
ICD-10 code description: central sensitization

Primary outcomes

1

Description: Central Sensitization Questionnaire
Timepoint: One day before the start of the intervention and one day after the end of the intervention for four weeks (12 sessions)
Method of measurement: Central Sensitivity Questionnaire, Persianized version

2

Description: Pain Pressure Threshold
Timepoint: One day before the start of the intervention and one day after the end of the intervention for four weeks (12 sessions)
Method of measurement: Algometer

3

Description: pain
Timepoint: One day before the start of the intervention and one day after the end of the intervention for four weeks (12 sessions)
Method of measurement: VAS

4

Description: Pain Catastrophizing
Timepoint: One day before the start of the intervention and one day after the end of the intervention for four weeks (12 sessions)
Method of measurement: Persian version of the Pain Catastrophizing Questionnaire

5

Description: TSK Questionnaire
Timepoint: One day before the start of the intervention and one day after the end of the intervention for four weeks (12 sessions)
Method of measurement: Persian version of the TSK Questionnaire

6

Description: Oswestry Disability
Timepoint: One day before the start of the intervention and one day after the end of the intervention for four weeks (12 sessions)
Method of measurement: Persian version of the Oswestry Disability Questionnaire

7

Description: electromyographic activity of trunk muscles
Timepoint: One day before the start of the intervention and one day after the end of the intervention for four weeks (12 sessions)
Method of measurement: Surface Electromyography device

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group:Individuals in this group will play games and exercise with the Xbox 360 Kinect for 30–45 minutes and should not have a history of using the Kinect or engaging in strenuous professional exercise. Each session will include a 10-minute warm-up and 5-minute cool-down. Exercise will be performed at a distance of 3 meters from the device and a 48-inch screen, and rest will be allowed if fatigue occurs. Exercise intensity will be maintained at 64–76% HRmax by monitoring heart rate. Games will be selected from Kinect Adventures and intensity will be adjusted by changing time or repetitions as needed. If pain or disability increases, exercise will be stopped or the individual will be withdrawn from the study.
Category: Treatment - Devices

Recruitment centers

1

Recruitment center: Name of recruitment center

Tarbiat Modares University

Full name of responsible person

Dr Sedighe Kahrizi

Street address

Tehran Jalal Al Ahmad Nasr Underpass

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 82880

Fax

+98 21 8800 6544

Email

prtmu@modares.ac.ir

1

Sponsor: Name of organization / entity

Research Deputy of Tarbiat Modares University

Full name of responsible person

DR. Mohammad Javan

Street address

Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 82880

Fax

+98 21 8800 6544

Email

prtmu@modares.ac.ir

Web page address
Grant name: Research Deputy of Tarbiat Modares University
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Research Deputy of Tarbiat Modares University
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Behdokht Dehqan

Position

Student of PHD in Physical Therapy

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University, Jalale al e ahmad Ave, Kouye Nas

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8609 3437

Email

behdokht.dehqan@odares.acir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Sedighe Kahrizi

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University,Jalale al e ahmad Ave, Kouye Nasr

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8828 4511

Email

Kahrizis@modares.ac.ir

Web page address

https://www.modares.ac.ir/~kahrizis

Person responsible for updating data

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Sedighe Kahrizi

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University,Jalale al e ahmad Ave, Kouye Nasr

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8828 4511

Email

kahrizis@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Not applicable
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: File of intervention program protocol and statistical analysis plan through publication of thesis and writingan article
When the data will become available and for how long: Starting 6 months after publication of results
To whom data/document is available: The research team of this study and other clinical academic researchers who are studying in favor of these patients.
Under which criteria data/document could be used: Researchers who intend to write a meta-analysis or systematic review articles are allowed to access document.
From where data/document is obtainable: Sedighe Kahrizi ; Behdokht Dehqan
What processes are involved for a request to access data/document: The request will be responded after getting the approval of university or the academic institution
Comments

The effects of exercise therapy with VR on sensory, psychosocial symptoms, and electromyographic activity of trunk muscles during functional tasks in chronic low back pain patients with high central sensitization.