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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05953727
Collaborator
(none)
36
2
2
10.6
18
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Low level laser therapy with proprioceptive stimulation
  • Other: Low level laser therapy without proprioceptive stimulation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 11, 2022
Anticipated Primary Completion Date :
Aug 15, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low level laser therapy with proprioceptive stimulation

Patients will be treated with low level laser therapy and proprioceptive stimulation will also be given.

Other: Low level laser therapy with proprioceptive stimulation
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.
Other Names:
  • Heating packs
  • Active Comparator: Low level laser therapy without proprioceptive stimulation

    Patients will be treated with low level laser therapy only.

    Other: Low level laser therapy without proprioceptive stimulation
    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.
    Other Names:
  • Heating packs
  • Outcome Measures

    Primary Outcome Measures

    1. Nottingham Sensory Assessment [6 weeks]

      Multimodal sensory examination includes test of tactile sensation, kinesthesia and stereognosis.

    2. NPRS [6 weeks]

      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'.

    3. Step length [6 weeks]

      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.

    4. Stride Length [6 weeks]

      The distance covered in centimeters with two consecutive steps, one with each foot.

    5. Walking Cadence [6 weeks]

      Number of steps taken by an individual in one minute

    Secondary Outcome Measures

    1. 6 Minute Walk Test (6MWT) [6 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Agile Rehabilitation Complex Bahawalpur Punjab Pakistan 63100
    2 Bahawal Victoria Hospital Bahawalpur Punjab Pakistan 63100

    Sponsors and Collaborators

    • Riphah International University

    Investigators

    • Principal Investigator: Hira Jabeen, Riphah International University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT05953727
    Other Study ID Numbers:
    • REC/RCR & AHS/23/0220
    First Posted:
    Jul 20, 2023
    Last Update Posted:
    Jul 20, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riphah International University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2023