To determine the effectiveness of conventional physical therapy with and without Low Level Laser Therapy on pain, functional disability, ROM and Straight Leg Raise in patients with discogenic lumbar radiculopathy.
Design
Double Blind Randomized Controlled Trial with a parallel group design of 140 patients will have random allocation by Sealed Envelope Method.
Settings and conduct
Patients from the Physical Therapy Departments of Polyclinic, NIRM and Rawal hospitals, Islamabad Pakistan. The patients and outcome assessor will be kept blind during the whole trial regarding the treatment groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Age group between 25- 50 years
Both male and female patients
Newly diagnosed cases of discogenic lumbar radiculopathy
Patients with at least moderate score (21% - 40%) in Oswestry Disability Index
Patients with positive SLR or Lasègue's test
Exclusion Criteria
Patients receiving treatment by other methods for the last 3 months
Lumbar spine surgery within the past year
Spondylolisthesis
Ankylosing spondylitis
Cauda equina syndrome
Any co-morbid diseases
Intervention groups
Patients will be randomly assigned to a treatment group by Sealed Envelope Method, either an Experimental Group (Low level Laser Therapy and Conventional Physical Therapy) or a Control Group (Conventional Physical Therapy alone). The treatment procedures for both groups will be repeated for 3 sessions per week for 6 weeks (18 sessions) and a follow up consultation over a maximum period of Four weeks. The readings will be taken for two times (Pre-Treatment and Post-Treatment) during the whole session.
Main outcome variables
Visual Analogue Scale for Pain Intensity.
Dual Inclinometer for L-ROM
Oswestry Disability Index) for Functional Disability
Straight Leg Raise or Lasègue's Test for Lumbar Radiculopathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190707044128N2
Registration date:2020-03-13, 1398/12/23
Registration timing:registered_while_recruiting
Last update:2020-03-13, 1398/12/23
Update count:0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Ishaq Ahmed
Name of organization / entity
The university of Lahore
Country
Pakistan
Phone
+92 42 37592112
Email address
ishaqpt786@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-15, 1398/11/26
Expected recruitment end date
2020-04-15, 1399/01/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Low Level Laser Therapy in Discogenic Lumber Radiculopathy; A Double Blind Randomized Controlled Clinical Trial
Public title
Low Level Laser Therapy in Discogenic Lumber Radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group between 25- 50 years
Both male and female patients
Newly diagnosed cases of discogenic lumbar radiculopathy
Patients with at least moderate score (21%-40%) in Oswestry Disability Index
Patients with positive SLR or Lasegue's test
Exclusion criteria:
Patients receiving treatment by other methods like vapocoolants, dry needling, laser acupuncture, subdural steroid injections etc. for the last 3 months
Lumbar spine surgery within the past year
Spondylolisthesis
Ankylosing spondylitis
Vascular, neurological or rheumatic disorders
Clinical evidence of any myelopathy or joint disorders
Recent fracture of the lumbar vertebral spine
Cauda equina syndrome
Osteoporosis
Clinical evidence of any tumor or any space occupying lesion.
Any co-morbid diseases
Age
From 25 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be allocated into two groups i.e. an Experimental Group and a Control Group by Randomization through Sealed Envelope Method. The Experimental Group patients will be treated with Low Level Laser Therapy along with Conventional Physical Therapy while those in the Control Group will be given Conventional Physical Therapy alone.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and the outcome assessor will be kept blind. Allocation of patients into the Experimental and Control group will be random through Sealed Envelope Method.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Board of Advanced Studies and Research, The University of Lahore
Street address
1-km Defence Road, Off Bhobatian Chowk
City
Lahore
Postal code
54590
Approval date
2019-06-05, 1398/03/15
Ethics committee reference number
UOL/UIPT/BSAR/DPTH02163001
Health conditions studied
1
Description of health condition studied
Lumbar disc herniation is a displacement / protrusion of disc material (nucleus pulposus or annulus fibrosis) beyond the intervertebral disc space. The prolapsed nucleus pulposus will often come in contact with the nearby spinal nerves, results in the compression of these nerves which in turn results in severe radicular pain. Herniated discs are the common cause of lower back pain (LBP), hip and leg pain. The onset of pain may begin suddenly or gradually after injury. Typically, the pain is located bilaterally at the posterior belt line. The pain pattern is usually referred rather than radicular with a sharp, shooting pain running down the lower back, buttocks and down the thigh along with numbness or tingling sensations. The pain is aggravated by prolonged sitting, standing, forward bending or twisting movements and is relieved by walking, lying down, rest and a recumbent position.
ICD-10 code
M54.16
ICD-10 code description
Radiculopathy, lumbar region
Primary outcomes
1
Description
Pain Intensity
Timepoint
At the start of treatment and then after 18 treatment sessions for each patient.
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Functional Disability
Timepoint
At the start of treatment and then after 18 treatment sessions for each patient.
Method of measurement
ODI (Oswestry Disability Index)
3
Description
Lumber Range of Motion
Timepoint
At the start of treatment and then after 18 treatment sessions for each patient.
Method of measurement
Dual Inclinometer
Secondary outcomes
1
Description
Sciatic Nerve mobility
Timepoint
At the start of treatment and then after 18 treatment sessions for each patient.
Method of measurement
Straight Leg Raise or Lasegue's Test
Intervention groups
1
Description
Intervention group: Group-A of 70 patients will be treated with Low level Laser Therapy (LLLT) -830nm, 0.67 W/cm2 or 300 mW/cm2 at (Lumber-4,5 and Sacral-1 area) and Conventional Physical Therapy – McKenzie technique (1 set of 5 repetitions ), Hot Pack (10 mins), Hold Relax with sustained stretch (1 set of 5 repetitions with 15 seconds hold), Sciatic nerve mobilizations in 1 set of 5 repetitions.
Category
Treatment - Other
2
Description
Control group: Group-B of 70 patients will be treated with Conventional Physical Therapy alone – McKenzie technique (1 set of 5 repetitions ), Hot Pack (10 mins), Hold Relax with sustained stretch (1 set of 5 repetitions with 15 seconds hold), Sciatic nerve mobilizations in 1 set of 5 repetitions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Poly Clinic Hospital
Full name of responsible person
Dr. Daud Niazi
Street address
44 Luqman Hakeem Rd, G-6/2 G 6/2 G-6, Islamabad, Islamabad Capital Territory
City
Islamabad
Postal code
44000
Phone
+92 51 9218300
Email
info@fgpc.com.pk
2
Recruitment center
Name of recruitment center
National Institute of Rehabilitative Medicine
Full name of responsible person
Dr. Zahoor Ahmed
Street address
Street 9, Sector G-8/2, Islamabad.
City
Islamabad
Postal code
44000
Phone
+92 51 9262213
Email
info@nirm.com.pk
3
Recruitment center
Name of recruitment center
Rawal Hospital
Full name of responsible person
Dr. Nadia Shaheen
Street address
Lehtrar Rd, Taramri, Tarlai Kalan
City
Islamabad
Postal code
45550
Phone
+92 51 2617381
Email
info@rgh.com.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. Ashfaq Ahmed
Street address
1-Km Defence Road, Off Bhobatian Chowk
City
Lahore
Postal code
54590
Phone
+92 42 35322501
Email
info@uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. Ishaq Ahmed
Position
Assistant Professor/ Head of Physical Therapy Department
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
6.7-Km, Japan Road, Sihala, Zone-5
City
Islamabad
Province
Punjab
Postal code
75500
Phone
+92 51 4486422-6
Email
ishaqpt786@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Lahore
Full name of responsible person
Ishaq Ahmed
Position
Assistant Professor/Head of Department
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Japan Road, Sihala
City
Islamabad
Province
Punjab
Postal code
75500
Phone
+92 42 37592112
Fax
Email
ishaqpt786@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The university of Lahore
Full name of responsible person
Ishaq Ahmed
Position
Assistant Professor/Head of Department
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Japan Road, Sihala
City
Islamabad
Province
Punjab
Postal code
75500
Phone
+92 42 37592112
Fax
Email
ishaqpt786@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Consent form, Clinical Study Report, Statistical Plan files can be shared
When the data will become available and for how long
2 months after Publication
To whom data/document is available
People working in academic institutions or people working in businesses can also apply to receive it
Under which criteria data/document could be used
Intervention Purpose
From where data/document is obtainable
ishaqpt786@gmail.com
What processes are involved for a request to access data/document
Full description about the purpose/aim of using the documents, Insight about the disorder and Intervention of the research