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Completed

NCT Number: NCT05253599

Radiographic and Inflammatory Biomarker Changes in Chronic Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isokinetic training

Device

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.

Virtual reality training

Device

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.

Exercises

Other

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.

Primary outcomes

  1. Pain Intensity

    Time frame: At Baseline

    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.

  2. 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.

  3. Trunk flexor & extensor muscle strength

    Time frame: At Baseline

    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.

  4. 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

  1. Para spinal CSA

    Time frame: Baseline and after 4 weeks

    Cross sectional area (CSA) is an area exposed by cut through at right angles to an axis. T2 weighted images of para spinal muscles (PM: Psoas Major, QL: Quadratus Lumborum, Mf: Multifidus and ES: Erector Spinae) CSA were taken using a 3-T MRI-scanner (Closed MRI system, Siemens, Hamburg, Germany) with a slice thickness of 5 mm. The subjects were placed in a supine position with a pillow kept under the knees to maintain the normal lordosis of the lumbar spine. The CSA at the level of L3-L4 was selected because of their maximal size at this level.

  2. Muscle thickness

    Time frame: Baseline and after 4 weeks

    Muscle size is considered as the thickness of muscle and the thickness of Multifidus muscle was measured by the diagnostic ultrasound device (Hitachi Ultrasound, Tokyo, Japan) which is the most reliable and valid method of measurement. The thickness of multifidus was taken from the left and right side of the L4 and L5 level. The subject lies in a prone position with a pillow under the abdomen to maintain lordosis. The thickness of the muscle was measured by measuring the distance between the most superficial portion of the facet joint and the plane between the muscle and the skin.

  3. Inflammatory Biomarker

    Time frame: Baseline and after 4 weeks

    Subject's blood samples of 10 ml were taken in sterile tubes between 08:00 - 10:00 am. Serum was separated and centrifuged, which was frozen at -700 C and stored. Serum levels of CRP, TNF-α, IL-2, IL-4, IL-6 were measured by enzyme-linked immunosorbent assay (ELISA) technique. The kit was used according to the guidelines of the manufacturer. The lower and upper limits of detection were computed for each assay, and the average percentages of samples were reported for statistical analysis.

Sponsors and collaborators

Lead sponsor

Prince Sattam Bin Abdulaziz University

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2022
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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