Radiculopathy Lumbar Clinical Trial
Official title:
The Effect of High-power Laser Therapy on Pain, Functional Disability, Range of Motion and Pressure Pain Threshold in Subjects With Radicular Low Back Pain Due to Intervertebral Disc Herniation: A Double-blind Randomised Controlled Trial
Verified date | November 2023 |
Source | Iran University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Low back pain is the predominant cause of disability on a global scale. In the year 2015, the worldwide point prevalence of activity-limiting low back pain stood at 7·3%, suggesting that at any given moment, 540 million individuals were afflicted. In that same year, low back pain emerged as the primary cause of involuntary labor leave and premature retirement within Europe. In the United States, 44% of patients have utilized their health insurance for low back pain at least once, and 1 to 2% (approximately 3 million individuals) exhibit symptoms of sciatica as a result of a lumbar intervertebral disc herniation. Given the prevalence of disorders attributable to L4-L5 and L5-S1 intervertebral disc herniation, it is imperative to consider the potential risks associated with both surgical and non-surgical medical interventions, such as corticosteroid injections. Laser therapy emerges as a viable modality within the realm of physical therapy, particularly in the mitigation of inflammation. The modulating effects of laser therapy on inflammation have been documented, with no significant side effects reported thus far. Should the efficacy of laser therapy be substantiated, it could be incorporated into the suite of treatments endorsed by authoritative guidelines pertaining to back pain. Patients afflicted with radicular back pain have been the beneficiaries of assistance from physiotherapists possessing specialized knowledge in effective dosimetry. The objectives of this assistance include the amelioration of pain symptoms, the enhancement of functional indicators, the augmentation of the range of motion, and the modulation of the pressure pain threshold, all without the concern of side effects. Furthermore, adherence to the correct treatment protocol is of paramount importance. The main objective of this study is to evaluate the effect of active high-power laser compared to sham laser on pain, disability, range of motion, and pressure pain threshold in patients with radicular low back pain due to lumbar intervertebral disc herniation.
Status | Enrolling by invitation |
Enrollment | 36 |
Est. completion date | April 25, 2024 |
Est. primary completion date | April 25, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 60 Years |
Eligibility | Inclusion Criteria: - The diagnosis of radicular low back pain, originating from an intervertebral disc herniation between the fourth lumbar and first sacral vertebrae, is confirmed by a neurosurgeon - A minimum of 12 weeks have elapsed since the onset of symptoms. The patient experiences persistent pain or paraesthesia (numbness and/or tingling) in the lower back or both limbs, attributable to the herniation of the lumbar intervertebral disc impinging on the nerve root dermatome - Magnetic Resonance Imaging (MRI) scans of the patients reveal either protrusion or extrusion disc herniation. Exclusion Criteria: - Local or systemic infection, rheumatic disease, diabetes - Vertebral and sacroiliac joint dysfunction (Gillette test positive) - Pregnancy - History of previous surgery in the area - Patients with MRI of spinal canal stenosis or spondylolisthesis - Patients with vascular disorders, cancer and tumors and synovial cysts - History of physiotherapy for at least the last 12 weeks - sciatic nerve Contusion - psychiatric illnesses - Active trigger point of gluteus minimus muscle (diffuse sciatica-like pain) |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | School of Rehabilitation Sciences, Iran University of Medical Sciences | Tehran |
Lead Sponsor | Collaborator |
---|---|
Iran University of Medical Sciences |
Iran, Islamic Republic of,
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* Note: There are 72 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) | The Visual Analog Scale, rated from zero (indicating no pain) to 10 (representing the most severe pain conceivable), will be utilized to assess lumbar and affected extremity pain | This scale will be measured by the assessor prior to the intervention, four weeks after start of treatment, and one month post-treatment. The average pain experienced over the preceding seven days will be recorded as the VAS score | |
Secondary | Functional Disability | The functional disability will be evaluated using the validated and reliable Oswestry questionnaire, validated by Mousavi et al. in 2006. | This assessment will be conducted by the assessor before the start of treatment, four weeks after start of tratment , and one month post-treatment. | |
Secondary | Pressure Pain Threshold | An algometer will be employed to measure the pressure pain threshold. The algometer will record each point thrice, and the average value per point will be documented. The measurements will be taken at specific points on the body, including 2 and 5 cm lateral to the first and third lumbar vertebrae, 2 cm lateral to the fifth lumbar vertebra, on the common peroneal nerve, tibial nerve, and the sciatic nerve. | These assessments will be conducted before the start of treatment, four weeks after treatment, and one month post-treatment. | |
Secondary | Range of Motion | The active range of motion of the lumbar region (measured using the modified-modified Schubert test) and the Straight Leg Raise (SLR) range of motion of the affected lower limb (measured using a goniometer) will be assessed. | These assessments will be conducted before the start of treatment, four weeks after treatment, and one month post-treatment. |
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Completed |
NCT04276519 -
Position-Induced Opening of the Intervertebral Foramen is Efficient to Treat an Acute Lumbosacral Radiculopathy Caused by Disc Herniation
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N/A |