NCT05253599

Radiographic and Inflammatory Biomarker Changes in Chronic Low Back Pain

Effect of Different Exercise Training Methods on the Radiographic and Inflammatory Biomarkers (CRP, TNF-α, IL-2, IL-4, IL-6) in Chronic Low Back Pain: A Randomized Control Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Prince Sattam Bin Abdulaziz University · Academic / Other
• Sex: Male
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVE: To find and compare the effects of isokinetic training and virtual reality training on pain intensity, trunk muscle strength, radiographical (muscle cross-sectional area and muscle thickness), and biochemical effects in chronic low back pain (LBP) patients.

Detailed description

OBJECTIVE: To find and compare the effects of isokinetic training and virtual reality training on pain intensity, trunk muscle strength, radiographical (muscle cross-sectional area and muscle thickness), and biochemical effects in chronic low back pain (LBP) patients. METHODS: Randomized, double-blinded controlled study was conducted on 60 LBP patients and they were divided into isokinetic training (IKT; n=20), virtual reality training (VRT; n=20), and a control group (n=20). The VRT group received virtual training for core muscles of the trunk, the IKT group received training for trunk muscles through an Isokinetic dynamometer and the control group received conventional trunk balance exercises. Pain intensity (visual analog scale -VAS), trunk muscle strength, radiographical (muscle cross-sectional area through Magnetic resonance imaging - MRI \& muscle thickness through Ultrasound - US), and biochemical (CRP, TNF-α, IL-2, IL-4, IL-6) variables were measured at baseline and after 4 weeks (short term effect) of training.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DEVICE	Isokinetic training	The knees were flexed slightly at 15 degrees, and the fixation straps were tied around the popliteus, thigh, pelvis, chest and scapula to prevent the tricky movements.
DEVICE	Virtual reality training	Training was given in the sitting position which provides challenges to the balance activities of the participant. The game which was used in the current study was a shooting game, which consists of the subject sitting on the virtual platform and visualizing the game on the display screen. The game was executed and controlled by moving the trunk back and forth and left and right according to the signs. Participants can perform all the six movements of their spine within their pain limits. The level of difficulty of the exercises was increased by graded activity, in which the activities were gradually getting difficult and harder as participants required more muscle activity and movement.
OTHER	Exercises	They performed these exercises 10-15 reps/day for 5 days per week for 4 weeks. Stretching was focused on each muscle group for 3 repetitions for 10 seconds per muscle group (Hamstring, Hip flexors and Lumbar Extensors).7 A home-based exercise protocol was prescribed to all the subjects to perform at home. All the subjects in three groups were undergone hot pack therapy for 20 mins and ultrasound with a frequency of 1 Mhz and intensity of 1.5 W/cm2 in continuous form for five minutes.

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-06-30
• Completion: 2021-12-31
• First posted: 2022-02-24
• Last updated: 2022-02-24

Locations

1 site across 1 country: Saudi Arabia