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

Disk Herniated Lumbar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05261815
• Other study ID #: REC-FSD-00244
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disk Herniated Lumbar
• Hernia

Intervention

Other:
• Ultrasound Therapy
Ultrasound Therapy improves the pain management in patients with herniation. It eases down the severity of symptoms as well.
• 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.

Locations

Country	Name	City	State
Pakistan	Ripah International University	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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