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Clinical Trials/NCT05253599
NCT05253599
Completed
Not Applicable

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.

Prince Sattam Bin Abdulaziz University1 site in 1 country60 target enrollmentNovember 1, 2019
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Prince Sattam Bin Abdulaziz University
Enrollment
60
Locations
1
Primary Endpoint
Pain Intensity
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gopal Nambi

Associate Professor

Prince Sattam Bin Abdulaziz University

Eligibility Criteria

Inclusion Criteria

  • University male football players
  • Age group of 18 - 25 years
  • chronic (≥3 months) LBP,
  • 4 to 8 pain intensity in visual analog scale (VAS).

Exclusion Criteria

  • Participants with severe musculoskeletal, neural, somatic, and psychiatric conditions,
  • Waiting for spine surgery,
  • Having alcohol or drug abuse,
  • Involved in other weight and balance training programs.
  • Participants with other soft tissue injuries, fractures in the lower limbs and pelvic bone, deformities.

Outcomes

Primary Outcomes

Pain Intensity

Time Frame: After 4 weeks

The pain intensity was measured by visual analog scale (VAS) which consist of a 10 cm horizontal line representing one end with "no pain at all" and the other end with "as bad as possible it could be." Each subject was asked to enter in the line as per his pain perception at rest and the score was measured by the distance on the line. The reliability and validity of VAS in application of musculoskeletal conditions was good.

Trunk flexor & extensor muscle strength

Time Frame: After 4 weeks

The trunk flexor and extensor muscles' peak torque was measured by using isokinetic dynamometer. The participant was positioned in standing position and wrapped the lower extremities with Velcro straps to prevent trick movements. Three measurements were taken at 900 per second for trunk flexors and extensors and the average value was considered for data analysis. The reliability and validity of this method of application in low back pain condition was good.

Secondary Outcomes

  • Para spinal CSA(Baseline and after 4 weeks)
  • Muscle thickness(Baseline and after 4 weeks)
  • Inflammatory Biomarker(Baseline and after 4 weeks)

Study Sites (1)

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