Radiographic and Inflammatory Biomarker Changes in Chronic Low Back Pain
NCT ID: NCT05253599
Last Updated: 2022-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2019-11-01
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Inspiratory Muscle Trainers on Patients With Obesity and LowBack Pain
NCT07320469
Evaluation of Effectiveness of Proprietary Rehabilitation Program in Patients After COVID-19 Infection
NCT05449379
Imaging Biomarkers of the Effects of a Mixed Exercise Program
NCT03834558
The Effect of Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients
NCT05303623
The Effects of Blood Flow Restriction-based Abdominal draw-in Maneuver on Activation of Abdominal Core Muscles in Patients With Non-specific Low Back Pain
NCT05996341
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Isokinetic training
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.
Isokinetic training
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
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.
Virtual reality training
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.
Control group
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).
Exercises
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Isokinetic training
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
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
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age group of 18 - 25 years
* chronic (≥3 months) LBP,
* 4 to 8 pain intensity in visual analog scale (VAS).
Exclusion Criteria
* 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.
18 Years
25 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prince Sattam Bin Abdulaziz University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gopal Nambi
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dr. Gopal Nambi
Al Kharj, Riyadh Region, Saudi Arabia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RHPT/019/036
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.