Effectiveness of High Intensity Laser Therapy in Management of Lumbar Disc Herniation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBaskent University

About this trial

Chronic lumbar radiculopathy is a multifactorial condition typically caused by lumbar disc herniation, where degenerative changes lead to nerve root compression, resulting in radiating pain, sensory disturbances, and motor deficits. Management requires a multidisciplinary, primarily conservative approach centered on physical therapy, including exercise, electrotherapy, and other non-invasive modalities. Exercise plays a key role in improving spinal stability, mobility, posture, and neuromuscular coordination, while treatments like transcutaneous electrical nerve stimulation (TENS) and high-intensity laser therapy (HILT) provide pain relief through neuromodulation and tissue regeneration mechanisms. Recent evidence suggests that combining HILT with exercise may enhance functional outcomes more effectively than exercise alone. Accordingly, this study aims to compare the effectiveness of exercise alone, exercise combined with HILT, and exercise combined with conventional therapies (ultrasound, hot pack, and TENS) in patients with lumbar disc herniation. Patients aged 18-65 will be randomly assigned to three groups and undergo a 3-week treatment program, with outcomes assessed through measures of pain, disability, range of motion, and quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females aged 18-65 years

Diagnosed with lumbar disc herniation via MRI and presenting with low back pain

No History of lumbar physical therapy in the last 3 months

No History of analgesic or muscle relaxant use since initial presentation

Disqualifiers

History of Fibromyalgia diagnosis

History of acute trauma

History of Lumbar instability

History of Rheumatologic disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hiltherapy

    Device

    Nd:YAG laser (1064 nm) will be applied to the participants with high-peak power (3 kW), pulse duration 120-150 μs, frequency 10-30 Hz, energy density 360-1780 mJ/cm². Protective eyewear will be used. Protocol: scanning phase (rapid paravertebral scan), initial phase (trigger point scan), and final phase (slow scan of initial area). Total energy: 2,500 J/cm² (1,000 + 500 + 1,000). 15 sessions for 3 weeks, 15 min/session.

  • physiotherapy

    Device

    Combination of US + Hot pack + TENS will be applied to the participants Hot pack (15 × 50 cm, 15 min), ultrasound (1 MHz, 1.5 W/cm², 4+4 min bilateral), and TENS (20 min, 80 Hz, 180 μs, 4 electrodes 5 × 5 cm) for 15 sessions for 3 weeks.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: hiltherapyExperimental treatment 1 intervention
Group B: PhysiotherapyActive comparator 1 intervention
Group C: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Visual Analog Scale

The Visual Analog Scale (VAS) is a simple and widely used tool for assessing pain intensity by allowing patients to indicate their perceived level of pain on a continuous scale. It typically consists of a 10 cm line anchored by two extremes, "no pain" and "worst imaginable pain," on which the patient marks their current pain level. The score is determined by measuring the distance from the "no pain" end to the marked point, providing a value between 0 and 10, with higher scores indicating greater pain severity. VAS is favored in both clinical practice and research due to its ease of use, sensitivity to changes over time, and ability to quantitatively track treatment outcomes, although it may be less reliable in individuals with cognitive or communication difficulties.

Time frame
3 months

Secondary outcomes

1

• Functional disability via Oswestry Disability Index

The Oswestry Disability Index (ODI) is a widely used, condition-specific questionnaire designed to assess functional disability in individuals with low back pain. It consists of 10 sections covering daily activities such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment or homemaking. Each section is scored from 0 to 5, with higher scores indicating greater disability. The total score is calculated as a percentage, where 0-20% represents minimal disability, 21-40% moderate disability, 41-60% severe disability, 61-80% crippled, and 81-100% indicates patients who are either bed-bound or exaggerating symptoms. The ODI is commonly used in both clinical and research settings to evaluate the impact of low back pain on daily functioning and to monitor treatment outcomes over time.

Time frame
3 months
2

Short form-36

The Short Form-36 (SF-36) is a widely used health-related quality of life questionnaire that evaluates overall well-being across eight domains: physical functioning, role limitations due to physical and emotional problems, bodily pain, general health perception, vitality (energy/fatigue), social functioning, and mental health. It consists of 36 items, and each domain is scored separately on a scale from 0 to 100, with higher scores indicating better health status. The SF-36 provides a comprehensive assessment of both physical and mental health and is commonly used in clinical research to measure the impact of disease and treatment on quality of life.

Time frame
3 months

Other outcomes

1

Lumbar Range of Motion via goniometer (flexion, extension, lateral flexion, rotation, 3 trials, mean)

Lumbar range of motion (ROM) is assessed using a goniometer to objectively measure the degree of movement in the lumbar spine, including flexion, extension, lateral flexion, and rotation. During the assessment, each movement is performed three times to ensure reliability, and the average of these measurements is recorded as the final value. This method provides a quantitative evaluation of spinal mobility and is commonly used in clinical and research settings to monitor functional limitations and treatment outcomes in patients with low back pain.

Time frame
3 months

Sponsors and contacts

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