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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hiltherapy | Experimental | In this group Nd:YAG laser (1064 nm) will be applied to 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 will be applied for 3 weeks, 15 min/session. Participants will also receive 15 sessions (5 sessions/week for 3 weeks). |
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| Physiotherapy | Active Comparator | 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) will be applied for 15 sessions for 3 weeks. Participants will also receive 15 sessions (5 sessions/week for 3 weeks). |
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| control group | No Intervention | Participants will receive 15 sessions (5 sessions/week for 3 weeks). Each session will last 15 minutes under physiotherapist supervision and include lumbar extension, pelvic tilt, and core stabilization exercises as tolerated. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| • 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ozlem Kuculmez, assist prof dr | Contact | +905556205210 | ahmedzmm@outlook.com | |
| Derya aydil | Contact | +903122129065/2234 | etikkurul@baskent.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Sevgi İkbali Afşar, Prof. Dr. | BASKENT UNİVERSİTY | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baskent University | Ankara | Bahcelievler | 06490 | Turkey (Türkiye) |
For participants privacy
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Randomized controlled trial
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| 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. |
|
| 3 months |
| 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. | 3 months |
| 3 months |
| Baskent University | Ankara | 06490 | Turkey (Türkiye) |
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| Başkent University Ankara Hospital | Ankara | 06490 | Turkey (Türkiye) |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |