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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara City Hospital Bilkent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Patients with cardiac pacemakers

Patients with a diagnosis of inflammatory rheumatic disease,

Patients with a diagnosis of polyneuropathy that precludes receiving treatment,

Trial design

Design model

Parallel

Treatments tested in this trial

  • High intensity laser therapy

    Device

    lumbosciatalgia mode of the HILT device

  • Sham Comparator

    Device

    sham mode of the HILT device

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: HILT groupExperimental treatment 1 intervention
Group B: Sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
pre-treatment, immediately post-treatment and three months follow-up
2

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.

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

Secondary outcomes

1

Nottingham Health Profile (NHP)

This questionnaire includes 38 items assessing quality of life in 6 sections (pain, energy level, sleep, social isolation, emotional reaction, physical activity). Physical mobility (8 questions), pain (8 questions), sleep (5 questions), emotional reactions (9 questions), social isolation (5 questions) The evaluation was made by taking the percentage of yes answers. Each section is scored between 0 and 100. 0 indicates the best score and 100 indicates the worst score. Turkish validation of the NHP was conducted by Kucukdeveci AA. et al.

Time frame
pre-treatment, immediately post-treatment and three months follow-up
2

LANSS Pain Scale

The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale is a scale based on the analysis of data obtained during bedside examination. First used by Bennett, the LANSS Pain Scale is a very useful tool that provides immediate information in the clinical setting and helps to differentiate nociceptive pain from neuropathic pain. The LANSS Pain Scale is categorised in the range of 0-24 points. A score of 12 or more is in favour of neuropathic pain and a score below 12 is in favour of nociceptive pain. Turkish validity and reliability have been proven.

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

Other outcomes

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