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Radiographic and Inflammatory Biomarker Changes in Chronic Low Back Pain

P

Prince Sattam Bin Abdulaziz University

Status

Completed

Conditions

Low Back Pain

Treatments

Device: Isokinetic training
Other: Exercises
Device: Virtual reality training

Study type

Interventional

Funder types

Other

Identifiers

NCT05253599
RHPT/019/036

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Male

Ages

18 to 25 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

Isokinetic training
Experimental group
Description:
In the IKT group before isokinetic training, the subjects were asked to perform five minutes' warm-up followed by slow stretching of back extensors and flexors. The subject was asked to be in an isokinetic dynamometer (Biodex Corporation, New York, USA) in a vertical standing position.
Treatment:
Device: Isokinetic training
Virtual reality training
Experimental group
Description:
The VRT group received virtual reality training with (Pro-Kin system PK 252 N Techno body, Pelvic Module balance trunk MF, Italy) focusing on the balance of core stability muscles.
Treatment:
Device: Virtual reality training
Control group
Active Comparator group
Description:
The Control group focused on conventional balance training for core muscles. The training includes active isotonic and isometric exercise for abdominal muscles (Internal oblique, external oblique, transverse abdominus and Rectus abdominus) deep abdominal muscles (Psoas major, Psoas minor, Illiacus and Quadratus Lumborum) and back muscles (Erector spinae, Transverses spinalis, inter spinalis and Inter transverse).
Treatment:
Other: Exercises

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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