Clinical trial NCT05253599: Radiographic and Inflammatory Biomarker Changes in Chronic Low Back Pain
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Isokinetic training
Virtual reality training
Cross sectional area
muscle thickness
inflammatory biomarkers
chronic low back pain
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a double-blinded randomized control study and the subjects were randomized and allocated equally according to the computer random table method in a 1:1:1 ratio in three groups.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Pain Intensity
timeFrame: At Baseline
measure: Pain Intensity
timeFrame: After 4 weeks
measure: Trunk flexor & extensor muscle strength
timeFrame: At Baseline
measure: Trunk flexor & extensor muscle strength
timeFrame: After 4 weeks
Secondary outcomes:
measure: Para spinal CSA
timeFrame: Baseline and after 4 weeks
measure: Muscle thickness
timeFrame: Baseline and after 4 weeks
measure: Inflammatory Biomarker
timeFrame: Baseline and after 4 weeks
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Dr. Gopal Nambi
state: Riyadh
Study officials:
References: