Compare Effects of Ultrasound Therapy With High Intensity Laser Therapy for Treatment of Lumbar Disc Herniation.

Comparative Effectivness Between Ultrasound Therapy And High Intensity Laser Therapy In The Treatment Of Lumbar Disc Herniation.

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.

Study Overview

• Status: Completed
• Conditions: Disk Herniated Lumbar
• Intervention / Treatment: Other: Ultrasound Therapy; Other: High Intensity Laser Therapy

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalabad, Punjab, Pakistan, 38000
      • Ripah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound therapy; Continuous ultrasound therapy for 15 minutes; Traction for 30 minutes; Spinal decompression exercises for 20 min	Other: Ultrasound Therapy; Ultrasound Therapy improves the pain management in patients with herniation. It eases down the severity of symptoms as well.
Experimental: High Intensity Laser Therapy; High intensity laser for 10 minutes; Traction for 30 minutes; Spinal decompression exercises for 20 min	Other: High Intensity Laser Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12th Week
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	12th Week

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: February 20, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Randomized Control Trial; Lumbar; Comparison; High Intensity Laser Therapy; Ultrasound Therapy; Disc Herniation.
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: REC-FSD-00244

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