NCT05261815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

February 20, 2022

Last Update Submit

June 20, 2022

Conditions

Keywords

High Intensity Laser TherapyUltrasound TherapyLumbarDisc Herniation.Randomized Control TrialComparison

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Ultrasound therapy

EXPERIMENTAL

* Continuous ultrasound therapy for 15 minutes * Traction for 30 minutes * Spinal decompression exercises for 20 min

Other: Ultrasound Therapy

High Intensity Laser Therapy

EXPERIMENTAL

* High intensity laser for 10 minutes * Traction for 30 minutes * Spinal decompression exercises for 20 min

Other: High Intensity Laser Therapy

Interventions

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

Ultrasound 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.

High Intensity Laser Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient above age 18 and adult
  • Patient with lumbar disc herniation diagnosed by MRI
  • Patient with no history of trauma and congenital abnormalities

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Officials

  • Muhammad Kashif

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 2, 2022

Study Start

March 1, 2021

Primary Completion

March 25, 2022

Study Completion

March 31, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations