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IRCT20090203001637N14 IRCT 2026-02-11 Research Deputy of Tarbiat Modares University The effect of virtual reality exercise therapy in the treatment of chronic low back pain patients with high central sensitization. CS (Central ensitization) 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. 2026-04-11 anticipated 22 Recruiting https://irct.ir/trial/81041 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: To prevent assessment bias, evaluators will be blinded to the patients' group allocation (intervention or control). N/A non-specific low back pain (LBP) with high levels of central sensitization. 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 If pain or disability increases, exercise will be stopped or the individual will be withdrawn from the study.. Yes - There is a plan to make this available What will be shared: File of intervention program protocol and statistical analysis plan through publication of thesis and writingan article When: Starting 6 months after publication of results To whom: The research team of this study and other clinical academic researchers who are studying in favor of these patients. Conditions: Researchers who intend to write a meta-analysis or systematic review articles are allowed to access document. Where to obtain: Sedighe Kahrizi ; Behdokht Dehqan How to obtain: The request will be responded after getting the approval of university or the academic institution Comments:
public Behdokht Dehqan
Tarbiat Modares University, Jalale al e ahmad Ave, Kouye Nas
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8609 3437 behdokht.dehqan@odares.acir Tarbiat Modares University scientific Sedighe Kahrizi
Tarbiat Modares University,Jalale al e ahmad Ave, Kouye Nasr
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8828 4511 Kahrizis@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) 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). 18 years 60 years Both 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 central se central sensitization Treatment - Devices 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. 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. 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. 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. 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. 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. 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. 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. Research Deputy of Tarbiat Modares University Approved 2025-11-01 Ethics committee of Tarbiat modares University Tehran, Jalal Al-Ahmad, Nasr Crossing, Tarbiat Modares University Tehran Tehran Iran (Islamic Republic of)