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

Primary Purpose

Lumbar Radiculopathy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Low level laser therapy with proprioceptive stimulation
Low level laser therapy without proprioceptive stimulation
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring Discogenic Lumbar Radiculopathy, Gait Parameters, Low-Level Laser Therapy, Numeric pain rating scale

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Agile Rehabilitation ComplexRecruiting
  • Bahawal Victoria HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low level laser therapy with proprioceptive stimulation

Low level laser therapy without proprioceptive stimulation

Arm Description

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

Patients will be treated with low level laser therapy only.

Outcomes

Primary Outcome Measures

Nottingham Sensory Assessment
Multimodal sensory examination includes test of tactile sensation, kinesthesia and stereognosis.
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'.
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.
Stride Length
The distance covered in centimeters with two consecutive steps, one with each foot.
Walking Cadence
Number of steps taken by an individual in one minute

Secondary Outcome Measures

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.

Full Information

First Posted
June 26, 2023
Last Updated
July 12, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05953727
Brief Title
Low Level LASER Therapy With and Without Proprioceptive Stimulation Among Discogenic Lumbar Radiculopathy Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
Discogenic Lumbar Radiculopathy, Gait Parameters, Low-Level Laser Therapy, Numeric pain rating scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low level laser therapy with proprioceptive stimulation
Arm Type
Experimental
Arm Description
Patients will be treated with low level laser therapy and proprioceptive stimulation will also be given.
Arm Title
Low level laser therapy without proprioceptive stimulation
Arm Type
Active Comparator
Arm Description
Patients will be treated with low level laser therapy only.
Intervention Type
Other
Intervention Name(s)
Low level laser therapy with proprioceptive stimulation
Other Intervention Name(s)
Heating packs
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Low level laser therapy without proprioceptive stimulation
Other Intervention Name(s)
Heating packs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nottingham Sensory Assessment
Description
Multimodal sensory examination includes test of tactile sensation, kinesthesia and stereognosis.
Time Frame
6 weeks
Title
NPRS
Description
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'.
Time Frame
6 weeks
Title
Step length
Description
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.
Time Frame
6 weeks
Title
Stride Length
Description
The distance covered in centimeters with two consecutive steps, one with each foot.
Time Frame
6 weeks
Title
Walking Cadence
Description
Number of steps taken by an individual in one minute
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
6 Minute Walk Test (6MWT)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hira Jabeen
Phone
03234116506
Email
hira.jabeen@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hira Jabeen
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agile Rehabilitation Complex
City
Bahawalpur
State/Province
Punjab
ZIP/Postal Code
63100
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Hafeez
Phone
03212319576
Email
drhafeezarain@gmail.com
First Name & Middle Initial & Last Name & Degree
Arslan Saeed, DPT
Facility Name
Bahawal Victoria Hospital
City
Bahawalpur
State/Province
Punjab
ZIP/Postal Code
63100
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Irshad
Phone
03336352593
First Name & Middle Initial & Last Name & Degree
Arslan Saeed, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24239490
Citation
Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden JL, Bess S, Cho CH, DePalma MJ, Dougherty P 2nd, Fernand R, Ghiselli G, Hanna AS, Lamer T, Lisi AJ, Mazanec DJ, Meagher RJ, Nucci RC, Patel RD, Sembrano JN, Sharma AK, Summers JT, Taleghani CK, Tontz WL Jr, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014 Jan;14(1):180-91. doi: 10.1016/j.spinee.2013.08.003. Epub 2013 Nov 14.
Results Reference
background
PubMed Identifier
24768732
Citation
Fardon DF, Williams AL, Dohring EJ, Murtagh FR, Gabriel Rothman SL, Sze GK. Lumbar disc nomenclature: version 2.0: Recommendations of the combined task forces of the North American Spine Society, the American Society of Spine Radiology and the American Society of Neuroradiology. Spine J. 2014 Nov 1;14(11):2525-45. doi: 10.1016/j.spinee.2014.04.022. Epub 2014 Apr 24.
Results Reference
background
PubMed Identifier
20121353
Citation
Parker SL, Xu R, McGirt MJ, Witham TF, Long DM, Bydon A. Long-term back pain after a single-level discectomy for radiculopathy: incidence and health care cost analysis. J Neurosurg Spine. 2010 Feb;12(2):178-82. doi: 10.3171/2009.9.SPINE09410.
Results Reference
background
PubMed Identifier
19204216
Citation
Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
Results Reference
background
PubMed Identifier
35265302
Citation
Ahmed I, Bandpei MAM, Gilani SA, Ahmad A, Zaidi F. Effectiveness of Low-Level Laser Therapy in Patients with Discogenic Lumbar Radiculopathy: A Double-Blind Randomized Controlled Trial. J Healthc Eng. 2022 Feb 27;2022:6437523. doi: 10.1155/2022/6437523. eCollection 2022.
Results Reference
background
PubMed Identifier
28243143
Citation
Benditz A, Loher M, Boluki D, Grifka J, Vollner F, Renkawitz T, Maderbacher G, Gotz J. Positive medium-term influence of multimodal pain management on socioeconomic factors and health care utilization in patients with lumbar radiculopathy: a prospective study. J Pain Res. 2017 Feb 14;10:389-395. doi: 10.2147/JPR.S128090. eCollection 2017.
Results Reference
background
PubMed Identifier
27929617
Citation
National Guideline Centre (UK). Low Back Pain and Sciatica in Over 16s: Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK401577/
Results Reference
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Low Level LASER Therapy With and Without Proprioceptive Stimulation Among Discogenic Lumbar Radiculopathy Patients

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