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

July 12, 2023 updated by: Riphah International University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Bahawalpur, Punjab, Pakistan, 63100
        • Recruiting
        • Bahawal Victoria Hospital
        • Contact:
          • Muhammad Irshad
          • Phone Number: 03336352593
        • Principal Investigator:
          • Arslan Saeed, DPT
      • Bahawalpur, Punjab, Pakistan, 63100
        • Recruiting
        • Agile Rehabilitation Complex
        • Contact:
        • Principal Investigator:
          • Arslan Saeed, DPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nottingham Sensory Assessment
Time Frame: 6 weeks
Multimodal sensory examination includes test of tactile sensation, kinesthesia and stereognosis.
6 weeks
NPRS
Time Frame: 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'.
6 weeks
Step length
Time Frame: 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.
6 weeks
Stride Length
Time Frame: 6 weeks
The distance covered in centimeters with two consecutive steps, one with each foot.
6 weeks
Walking Cadence
Time Frame: 6 weeks
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)
Time Frame: 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Hira Jabeen, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2022

Primary Completion (Estimated)

August 15, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Radiculopathy

Clinical Trials on Low level laser therapy with proprioceptive stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe