Compare Effects of Ultrasound Therapy With High Intensity Laser Therapy for Treatment of Lumbar Disc Herniation.
Primary Purpose
Disk Herniated Lumbar
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ultrasound Therapy
High Intensity Laser Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Disk Herniated Lumbar focused on measuring High Intensity Laser Therapy, Ultrasound Therapy, Lumbar, Disc Herniation., Randomized Control Trial, Comparison
Eligibility Criteria
Inclusion Criteria:
- Patient above age 18 and adult
- Patient with lumbar disc herniation diagnosed by MRI
- Patient with no history of trauma and congenital abnormalities
Exclusion Criteria:
- If patient received anesthesia or corticosteroid within 4 week
- Patient with osteoporosis
- Patient with surgery or previous fracture of spinal stenosis
- A history of acute trauma like osteoarthritis, myofascial pain syndrome, inflammatory rheumatic disease, systemic lupus erythematosus, diabetes mellitus type 1 and 2, thyroid dysfunction, obesity, pacemaker, neurological pathologies and anxious- depressive syndrome.
- Pregnant women
Sites / Locations
- Ripah International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ultrasound therapy
High Intensity Laser Therapy
Arm Description
Continuous ultrasound therapy for 15 minutes Traction for 30 minutes Spinal decompression exercises for 20 min
High intensity laser for 10 minutes Traction for 30 minutes Spinal decompression exercises for 20 min
Outcomes
Primary Outcome Measures
Visual Analogue Scale
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Oswestry low back pain questionnaire
The Oswestry Low Back Pain Disability Questionnaire is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Secondary Outcome Measures
Full Information
NCT ID
NCT05261815
First Posted
February 20, 2022
Last Updated
June 20, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05261815
Brief Title
Compare Effects of Ultrasound Therapy With High Intensity Laser Therapy for Treatment of Lumbar Disc Herniation.
Official Title
Comparative Effectivness Between Ultrasound Therapy And High Intensity Laser Therapy In The Treatment Of Lumbar Disc Herniation.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)
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
Yes
5. Study Description
Brief Summary
The aim of this study is to assess and compare the effects of ultrasound therapy and High Intensity Laser Therapy, as the treatment option in case of lumbar disc herniation.
Detailed Description
A randomized control trail will be conducted in Safi teaching hospital near Riphah international university, after approval of synopsis. To evaluate the comparison and effect of Ultrasound therapy and High Intensity Laser Therapy, 30 patients will be randomly assigned to High Intensity Laser Therapy and Ultrasound group. Patients will be selected according to predefined inclusion and exclusion criteria. All the patients will be evaluated by computed tomography scan or magnetic resonance of lumbar spine. Non-probability convenient sampling will be used to approach the patients in hospital. Participants received 15 treatment session of High Intensity Laser Therapy and Ultrasound therapy over a period of three consecutive weeks (five days/week). Two types of tools will be used to evaluate the find out the comparison of both groups Visual analog scale and Oswestry lowback pain disability questionnaire. Data will be collected pre-treatment and post-treatment after 15 days. Data will be analyzed by Statistical Package of Social Sciences Version 20. Difference between pre-treatment to post treatment between group will be analyzed by Mann-Whitney test, and Within group difference will be analyzed by Wilcoxon signed- rank test. The level of statistical significance will be set as p< 0.05
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disk Herniated Lumbar
Keywords
High Intensity Laser Therapy, Ultrasound Therapy, Lumbar, Disc Herniation., Randomized Control Trial, Comparison
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The study would be double blinded as participants and assessors of the study would be kept blind of the treatment group to which the participant will be allocated.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound therapy
Arm Type
Experimental
Arm Description
Continuous ultrasound therapy for 15 minutes
Traction for 30 minutes
Spinal decompression exercises for 20 min
Arm Title
High Intensity Laser Therapy
Arm Type
Experimental
Arm Description
High intensity laser for 10 minutes
Traction for 30 minutes
Spinal decompression exercises for 20 min
Intervention Type
Other
Intervention Name(s)
Ultrasound Therapy
Intervention Description
Ultrasound Therapy improves the pain management in patients with herniation. It eases down the severity of symptoms as well.
Intervention Type
Other
Intervention Name(s)
High Intensity Laser Therapy
Intervention Description
Treatment of low disc herniation should be non-surgical, pharmacological and by physical therapy modalities. Laser radiation with high intensity used as a modality called high intensity laser therapy. It is used to relieve the pain by three process; Photo-chemical, Photo-thermal, Photo-mechanical. High Intensity Laser Therapy uses high intensity laser irradiation and low light absorption.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Time Frame
12th Week
Title
Oswestry low back pain questionnaire
Description
The Oswestry Low Back Pain Disability Questionnaire is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Time Frame
12th Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient above age 18 and adult
Patient with lumbar disc herniation diagnosed by MRI
Patient with no history of trauma and congenital abnormalities
Exclusion Criteria:
If patient received anesthesia or corticosteroid within 4 week
Patient with osteoporosis
Patient with surgery or previous fracture of spinal stenosis
A history of acute trauma like osteoarthritis, myofascial pain syndrome, inflammatory rheumatic disease, systemic lupus erythematosus, diabetes mellitus type 1 and 2, thyroid dysfunction, obesity, pacemaker, neurological pathologies and anxious- depressive syndrome.
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Kashif
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Ripah International University
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Compare Effects of Ultrasound Therapy With High Intensity Laser Therapy for Treatment of Lumbar Disc Herniation.
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