Low Level LASER Therapy With and Without Proprioceptive Stimulation Among Discogenic Lumbar Radiculopathy Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effects of low level laser therapy with and without proprioceptive stimulation on somatosensation, pain and gait parameters in patients with discogenic lumbar radiculopathy. The randomized central trial will recruit patients according to convenience sampling into two intervention groups randomly. One group will receive low level laser therapy and proprioceptive stimulation and other group will receive low level laser therapy alone. Heating packs will be given to both groups.

Detailed Description
-----------------
Lumbar disc prolapse occurs when disc material, that is, nucleus pulposus or annulus fibrosis comes out of the intervertebral disc space. The ruptured nucleus interacts with the nearby surrounding nerves, resulting in their compression that in turn causes severe radicular pain. Lumbar disc prolapse is considered as a hallmark of low back pain (LBP). Typically, the pain is distributed bilaterally at the posterior beltline with a sharp, shooting pain running down to the low back, buttocks, and down the thigh along with numbness or tingling sensations. One of the major risk factors for low back pain is lumbar disc prolapse. The prevalence of disc prolapse in lumbar region is 90% (L4-L5 or L5-S1). Low back pain due to disc prolapse is generally self-limiting and of shorter duration A double blind randomized controlled trial was conducted in 2022 by Ishaq et al. on 110 patients to determine the effectiveness of Low-Level Laser Therapy in Patients with Discogenic Lumbar Radiculopathy and correlation among pain intensity, functional disability, and lumbar range of motion (LROM). The outcomes of the treatment were measured on the first day and then after 18 sessions from each patient's pain intensity, functional disability, L-ROM, and straight leg raise by using visual analogue scale, Oswestry disability index, dual inclinometer, and straight leg raise tests. Experimental group of 55 patients was treated with LLLT and conventional physical therapy while the control group of 55 patients was treated with conventional physical therapy alone. They concluded that LLLT is an efficient adjunct therapy to conventional physical therapy in patients of discogenic lumbar radiculopathy In the reviewed literature, there seems to be a lack in establishing the effects of low-level laser therapy when combined with proprioceptive stimulation. Discogenic lumbar radiculopathy is very common due to an increased workload, increased number of road traffic accidents, poor postures and socioeconomic status, deficient medical or rehab services, and so on. Thus, there is need to conduct a research to determine the effects of low level laser therapy when combined with proprioceptive stimulation in improving patient's functional status, pain and gait issues.

Official Title
-----------------
Effects of Low Level Laser Therapy With and Without Proprioceptive Stimulation on Somatosensation, Pain And Gait Parameters in Patients With Discogenic Lumbar Radiculopathy

Conditions
-----------------
Lumbar Radiculopathy

Intervention / Treatment
-----------------
* Other: Low level laser therapy with proprioceptive stimulation
* Other: Low level laser therapy without proprioceptive stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 45-70years(27) Both male and female patients Patients with acute Low Back Pain and unilateral Discogenic Lumbar Radiculopathy with disc bulge confirmed on MRI Pain intensity score is 4 or more on the numeric pain rating scale (NPRS) Radiating leg pain symptoms for less than 4 weeks Numbness and paresthesia in the affected area Patients with moderate to severe score (21%-60%) in ODI Exclusion Criteria: Non willing patients Patients with severely cognitive disorders History of low back pain for more than 4 weeks History of any systemic disease such as Stroke, Multiple Sclerosis, Myopathies, Heart Failure etc Botulinum toxin injections to any lower extremity muscle in the last 3 months Malignancy

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low level laser therapy with proprioceptive stimulation<br>Patients will be treated with low level laser therapy and proprioceptive stimulation will also be given. | Other: Low level laser therapy with proprioceptive stimulation<br>* 10 minutes of low level laser therapy and 10-15 minutes of proprioceptive stimulation and 10 minutes of heating pack. Assessment and data collection will be done at baseline (initial), after 4 weeks of treatment protocol and patients will be followed up for the further 2 weeks to notice and report any change in condition and health status.<br>* Other names: Heating packs;|
| Active Comparator: Low level laser therapy without proprioceptive stimulation<br>Patients will be treated with low level laser therapy only. | Other: Low level laser therapy without proprioceptive stimulation<br>* 10 minutes of low level laser therapy and 10 minutes of heating pack. Assessment and data collection will be done at baseline (initial), after 4 weeks of treatment protocol and patients will be followed up for the further 2 weeks to notice and report any change in condition and health status.<br>* Other names: Heating packs;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nottingham Sensory Assessment | Multimodal sensory examination includes test of tactile sensation, kinesthesia and stereognosis. | 6 weeks | 
| NPRS | It is a common pain screening tool use to assess the severity of pain at moment time. It is '0-10' scale where '0' means 'no pain' and '10' means 'worst pain imaginable'. | 6 weeks | 
| Step length | The distance measured in centimeters between the point of initial contact of one foot and the point of initial contact of the opposite foot is referred to as the step length. | 6 weeks | 
| Stride Length | The distance covered in centimeters with two consecutive steps, one with each foot. | 6 weeks | 
| Walking Cadence | Number of steps taken by an individual in one minute | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walk Test (6MWT) | This is a sub-maximal exercise test used to assess aerobic capacity and endurance. Distance covered over a time of 6 minutes is used to compare changes in performance capacity. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Discogenic Lumbar Radiculopathy, Gait Parameters, Low-Level Laser Therapy, Numeric pain rating scale