Radiographic and Inflammatory Biomarker Changes in Chronic Low Back Pain

NCT05253599 | Completed DMC

• 1 other identifier: RHPT/019/036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Isokinetic training; Virtual reality training; Cross sectional area; muscle thickness; inflammatory biomarkers; chronic low back pain

Outcome Measures

Primary Outcomes (4)

• 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.

  At Baseline

• 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.

  After 4 weeks

• 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.

  At Baseline

• 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.

  After 4 weeks

Secondary Outcomes (3)

• Para spinal CSA

  Baseline and after 4 weeks

• Muscle thickness

  Baseline and after 4 weeks

• Inflammatory Biomarker

  Baseline and after 4 weeks

Study Arms (3)

Isokinetic training

EXPERIMENTAL

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.

Device: Isokinetic training

Virtual reality training

EXPERIMENTAL

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.

Device: Virtual reality training

Control group

ACTIVE COMPARATOR

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).

Other: Exercises

Interventions

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.

Isokinetic training

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.

Virtual reality training

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.

Control group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: University male football players in the age group of 18 - 25 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Dr. Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 24, 2022
• Study Start: November 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 4 weeks

Locations

SA (1)