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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06151704




Registration number
NCT06151704
Ethics application status
Date submitted
20/11/2023
Date registered
30/11/2023

Titles & IDs
Public title
The Effect of High-power Laser Therapy on Pain, Functional Disability, Range of Motion and Pressure Pain Threshold in Subjects With Radicular Low Back Pain Due to Intervertebral Disc Herniation
Scientific title
The Effect of High-power Laser Therapy on Pain, Functional Disability, Range of Motion and Pressure Pain Threshold in Subjects With Radicular Low Back Pain Due to Intervertebral Disc Herniation: A Double-blind Randomised Controlled Trial
Secondary ID [1] 0 0
IRCT20220410054486N1
Secondary ID [2] 0 0
IR.IUMS.REC.1401.089
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiculopathy, Lumbosacral Region 0 0
Radiculopathy Lumbar 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - High intensity laser therapy
Other interventions - Motor control exercise

Experimental: True high intensity laser therapy on lumbar region, sciatic, tibial, and peroneal nerves - The laser scanner, 50 cm from the skin, will target the area from the 12th ribs to the upper iliac crest, 4.2 cm lateral to the spine. The sciatic, tibial, and peroneal nerves will also be irradiated.

Sham comparator: Deactivated high intensity laser therapy, an audio device will mimic the laser's operational sound - the laser will remain deactivated, and an audio device will generate a simulation of the operational sound of the device. The subject will also participate in the same foundational treatment regimen involving motor control exercises as the intervention group.


Treatment: Other: High intensity laser therapy
The subject will receive high-intensity laser therapy in a prone position with a cushion under the abdomen and eye protection. The laser scanner, 50 cm from the skin, will target the area from the 12th ribs to the upper iliac crest, 4.2 cm lateral to the spine. The sciatic, tibial, and peroneal nerves will also be irradiated. A GaAlAs laser device will be used, with a power of 1.6 watts and a wavelength of 808nm. The initial dose will be 10 joules/cm², with an increment of 2 joules after every three sessions. The final dose will be 16 joules/cm².

Other interventions: Motor control exercise
Motor control exercise is defined as an exercise to increase control and coordination of the spine and pelvis. Normally, Motor control exercise increases the weak deep trunk muscles, such as transversus abdominis and multifidus, and reduces the overactive large external trunk muscles, such as rectus abdominal and erector spinae muscles. . All subjects participate in a foundational treatment regimen involving motor control exercises: isolated and combined contractions of the transverse abdominis and multifidus muscles in various positions. Contractions will initially be performed up to a maximum of 10 repetitions per movement, with each contraction sustained for a duration of 10 seconds. Commencing from the third week, the subject should be capable of comfortably executing 10 repetitions, sustaining the contraction for 10 seconds, and progressively increasing the intensity.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual Analog Scale (VAS)
Timepoint [1] 0 0
This scale will be measured by the assessor prior to the intervention, four weeks after start of treatment, and one month post-treatment. The average pain experienced over the preceding seven days will be recorded as the VAS score
Secondary outcome [1] 0 0
Functional Disability
Timepoint [1] 0 0
This assessment will be conducted by the assessor before the start of treatment, four weeks after start of tratment , and one month post-treatment.
Secondary outcome [2] 0 0
Pressure Pain Threshold
Timepoint [2] 0 0
These assessments will be conducted before the start of treatment, four weeks after treatment, and one month post-treatment.
Secondary outcome [3] 0 0
Range of Motion
Timepoint [3] 0 0
These assessments will be conducted before the start of treatment, four weeks after treatment, and one month post-treatment.

Eligibility
Key inclusion criteria
* The diagnosis of radicular low back pain, originating from an intervertebral disc herniation between the fourth lumbar and first sacral vertebrae, is confirmed by a neurosurgeon
* A minimum of 12 weeks have elapsed since the onset of symptoms. The patient experiences persistent pain or paraesthesia (numbness and/or tingling) in the lower back or both limbs, attributable to the herniation of the lumbar intervertebral disc impinging on the nerve root dermatome
* Magnetic Resonance Imaging (MRI) scans of the patients reveal either protrusion or extrusion disc herniation.
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Local or systemic infection, rheumatic disease, diabetes
* Vertebral and sacroiliac joint dysfunction (Gillette test positive)
* Pregnancy
* History of previous surgery in the area
* Patients with MRI of spinal canal stenosis or spondylolisthesis
* Patients with vascular disorders, cancer and tumors and synovial cysts
* History of physiotherapy for at least the last 12 weeks
* sciatic nerve Contusion
* psychiatric illnesses
* Active trigger point of gluteus minimus muscle (diffuse sciatica-like pain)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/05/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Iran, Islamic Republic of
State/province [1] 0 0
Tehran

Funding & Sponsors
Primary sponsor type
Other
Name
Iran University of Medical Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Seyed Mostafa Teymouri, Msc student
Address 0 0
Iran University of Medical Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sets of this study will be available on a reasonable request to the corresponding author
When will data be available (start and end dates)?
Starting 6 months after the publication.
Available to whom?
The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders and spine centers. The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of low back pain. Applicants can contact Seyed Mostafa Teymouri by Email. Email Address:teymouri.seyedmostafa@gmail.com Applicants should explain their project and how the data/documents of the study will be used in their project in detail. Then, the data/documents files will be sent by email to applicants on request. This process may take 10-12 working days
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06151704