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NCT Number: NCT07550569

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University, Ankara, Bahcelievler, Turkey (Türkiye)

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About this study

Chronic lumbar radiculopathy is a complex condition resulting from mechanical or inflammatory irritation of lumbar spinal nerve roots, most commonly due to lumbar disc herniation (LDH). In LDH, degeneration of the intervertebral disc leads to rupture of the annulus fibrosus and extrusion of the nucleus pulposus, compressing neural structures particularly at the L4-L5 and L5-S1 levels. This produces symptoms such as radiating low back pain, paresthesia, and motor dysfunction. Management of this condition requires a multidisciplinary and predominantly conservative approach, with physical medicine and rehabilitation forming the cornerstone. Treatment options include pharmacological therapy, manual therapy, physical modalities, and especially structured exercise programs. Exercise is essential not only for symptom relief but also for preventing recurrence, as it improves spinal stability, flexibility, posture, and neuromuscular coordination. Specific exercise types such as core strengthening, mobility, stabilization, postural correction, and proprioceptive training-target the underlying biomechanical and functional impairments associated with low back pain.

In addition to exercise, electrotherapy modalities such as transcutaneous electrical nerve stimulation (TENS) and high-intensity laser therapy (HILT) have gained increasing attention. TENS, approved by the FDA in 1976, reduces pain through mechanisms such as the gate control theory and endorphin release, with adjustable parameters allowing modulation of superficial and deep tissues. It is particularly useful for managing movement-related pain when applied before or after exercise. HILT, using a 1064 nm Nd:YAG laser, delivers high-energy pulses that penetrate deep tissues and provide analgesic, anti-inflammatory, and biostimulatory effects. It enhances mitochondrial activity, increases ATP production, improves microcirculation, promotes tissue repair, and reduces edema, thereby alleviating pressure on neural structures. Clinical studies have demonstrated that HILT is effective in reducing pain and improving function in patients with LDH, particularly when combined with exercise, and may lead to sustained improvements in quality of life.

Based on this evidence, the presented study is designed to compare the effectiveness of three treatment approaches in patients with lumbar disc herniation: exercise alone, exercise combined with HILT, and exercise combined with conventional physical therapy modalities (ultrasound, hot pack, and TENS). The study will include patients aged 18-65 diagnosed via MRI, with strict inclusion and exclusion criteria to ensure a homogeneous sample. Participants will be randomly assigned to one of the three groups and undergo a 3-week intervention consisting of 15 supervised sessions. The exercise program includes lumbar extension, pelvic tilt, and core stabilization exercises. The HILT protocol involves a structured application of Nd:YAG laser with specific energy and frequency parameters, while the conventional therapy group receives a combination of hot pack, ultrasound, and TENS. Outcomes will be evaluated using lumbar range of motion measurements, pain intensity via the Visual Analog Scale (VAS), functional disability via the Oswestry Disability Index (ODI), and quality of life via the SF-36 questionnaire. Overall, the study aims to determine the most effective conservative treatment strategy for improving pain, function, and quality of life in patients with lumbar disc herniation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Willingness to participate and signed informed consent

Exclusion criteria

  • History of Fibromyalgia diagnosis
  • History of acute trauma
  • History of Lumbar instability
  • History of Rheumatologic disease
  • Motor deficits or myelopathy
  • History of Lumbar injections in the last 3 months
  • History of Previous lumbar surgery
  • Pregnancy
  • Pacemaker
  • Cognitive impairment or unwillingness to comply with treatment

Treatment and study plan

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.

Primary outcomes

  1. Visual Analog Scale

    Time frame: 3 months

    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.

Secondary outcomes

  1. • Functional disability via Oswestry Disability Index

    Time frame: 3 months

    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.

  2. Short form-36

    Time frame: 3 months

    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.

Other outcomes

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

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Derya aydil

CONTACT

[email protected]

+903122129065/2234

Ozlem Kuculmez, assist prof dr

CONTACT

[email protected]

+905556205210

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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