Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation.

NCT06651775 | Recruiting

• 1 other identifier: E2-24-6770
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the researchers in this intervention study was to see the effects of High Intensity Laser Therapy (HILT) on participants' disability, functionality and pain parameters in chronic radicular low back pain due to lumbar disc herniation, and to investigate its superiority over widely used conventional electrotherapy modalities. The main question it aims to answer is: What is the short and long term effect of high intensity laser therapy on low back and leg pain in patients with chronic lumbar radiculopathy due to disc herniation? 35 patients in group A will receive the planned Hotpack, TENS, High Intensity Laser Therapy (HILT) and exercise treatments for lumbar radicular low back pain. In group B (comparison group) 35 patients will receive Hotpack, TENS, sham HILT, and exercise treatments. Participants will receive 15 sessions of treatment and exercises will be given as a home program. Both groups will complete questionnaires about disability, life functions and pain before and after treatment and at the 3rd month follow-up.

Conditions

Lumbar Radiculopathy

Keywords

Activity of Daily Living; chronic low back pain; high intensity laser therapy; pain

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS)

  Visual Analogue Scale (VAS) is used to convert some values that cannot be measured numerically into numerical form. On the two ends of a 100 mm line, two extreme definitions of the parameter to be evaluated are written and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line or putting a point or pointing. For example, for pain, no pain is written on one end, very severe pain is written on the other end and the patient marks his/her current situation on this line. The length of the distance from the point of no pain to the point marked by the patient indicates the patient's pain. The test has proven itself for a very long time and is recognised in the world literature. In our study, the VAS values of the patients for low back and leg pain at rest and in motion will be questioned and followed up.

  pre-treatment, immediately post-treatment and three months follow-up

• Revised Oswestry Disability Index (ODI)

  It was developed to assess the degree of loss of function in low back pain. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleeping, the degree of change in pain, travelling and social life. Under each item, there are six statements that the patient marks the appropriate one for his/her condition. The first statement is scored as "0" and the sixth statement as "5". When the total score is calculated, it is multiplied by two and expressed as a percentage. The maximum score is "100" and the minimum score is "0". The higher the total score, the higher the level of disability. Revised Oswestry Disability Index (ODI) consists of 10 items. Turkish validity and reliability was demonstrated in 2004.

  pre-treatment, immediately post-treatment and three months follow-up

Secondary Outcomes (2)

• Nottingham Health Profile (NHP)

  pre-treatment, immediately post-treatment and three months follow-up

• LANSS Pain Scale

  pre-treatment, immediately post-treatment and three months follow-up

Study Arms (2)

HILT group

EXPERIMENTAL

Receiving Hotpack+TENS+Exercises+HILT

Device: High intensity laser therapy

Sham group

SHAM COMPARATOR

Receiving Hotpack+TENS+Exercises+ sham HILT

Device: Sham Comparator

Interventions

High intensity laser therapy DEVICE

lumbosciatalgia mode of the HILT device

HILT group

Sham Comparator DEVICE

sham mode of the HILT device

Sham group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with lumbar radiculopathy due to lumbar disc herniation and whose complaints are correlated with lumbar MRI
• Patients aged 18-65 years
• Patients who agreed to participate in the study
• Literate patients

You may not qualify if:

• Pregnancy
• Patients with cardiac pacemakers
• Patients with a diagnosis of inflammatory rheumatic disease,
• Patients with a diagnosis of polyneuropathy that precludes receiving treatment,
• Patients with active or history of malignancy within the last 1 year and currently receiving chemotherapy and/or radiotherapy,
• Patients with serious psychiatric illness,
• Patients with severe coagulation disorders,
• Spinal Stenosis (patients with spinal canal diameter less than 8 mm)
• Patients with neurologic deficits that prevent them from receiving treatment,
• Patients with active infection,
• Patients with vasculitis,
• Patients with skin disease in the treated area,
• Patients who received steroid injections and/or physical therapy for the lumbar region within the last 3 months,
• Patients undergoing lumbar spine surgery,
• Patients with acute trauma,

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Cankaya, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Radiculopathy; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Berke Aras, associated professor

CONTACT

+90 536585 1518; drberkearas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 22, 2024
• Study Start: May 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: February 15, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)