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

Sponsor

Riphah International University (Other)

Overall Status

Completed

CT.gov ID

NCT05261815

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Disk Herniated Lumbar	Other: Ultrasound Therapy Other: High Intensity Laser Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Mar 25, 2022

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale [12th Week]
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 [12th Week]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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