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Radiographic and Inflammatory Biomarker Changes in Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Isokinetic training
Virtual reality training
Exercises
Sponsored by
Prince Sattam Bin Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Low Back Pain focused on measuring Isokinetic training, Virtual reality training, Cross sectional area, muscle thickness, inflammatory biomarkers, chronic low back pain

Eligibility Criteria

18 Years - 25 Years (Adult)MaleDoes not accept 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.

Sites / Locations

  • Dr. Gopal Nambi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Isokinetic training

Virtual reality training

Control group

Arm 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.

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.

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).

Outcomes

Primary Outcome Measures

Pain Intensity
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.
Pain Intensity
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
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.
Trunk flexor & extensor muscle strength
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 Outcome Measures

Para spinal CSA
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.
Muscle thickness
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.
Inflammatory Biomarker
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.

Full Information

First Posted
January 31, 2022
Last Updated
February 12, 2022
Sponsor
Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT05253599
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Isokinetic training, Virtual reality training, Cross sectional area, muscle thickness, inflammatory biomarkers, chronic low back pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Due to the design and settings of the study, it was not possible to blind the treating therapist involved in the study. The subject and the therapist who was assessing the outcomes at baseline and after 4 weeks were blinded. Hence, the treating and assessing therapists were different persons and the assessing therapist remains blinded to the subject's treatment group. Subjects were instructed not to disclose their study procedures and treatment protocol with fellow-subjects and the assessing therapist.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isokinetic training
Arm Type
Experimental
Arm 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.
Arm Title
Virtual reality training
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
Isokinetic training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual reality training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
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 Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
At Baseline
Title
Pain Intensity
Description
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.
Time Frame
After 4 weeks
Title
Trunk flexor & extensor muscle strength
Description
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.
Time Frame
At Baseline
Title
Trunk flexor & extensor muscle strength
Description
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.
Time Frame
After 4 weeks
Secondary Outcome Measure Information:
Title
Para spinal CSA
Description
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.
Time Frame
Baseline and after 4 weeks
Title
Muscle thickness
Description
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.
Time Frame
Baseline and after 4 weeks
Title
Inflammatory Biomarker
Description
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.
Time Frame
Baseline and after 4 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
University male football players in the age group of 18 - 25 years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Dr. Gopal Nambi
City
Al Kharj
State/Province
Riyadh
ZIP/Postal Code
11942
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be obtained by contacting the principal investigator
IPD Sharing Time Frame
4 weeks

Learn more about this trial

Radiographic and Inflammatory Biomarker Changes in Chronic Low Back Pain

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