Lomber Disc HerniationNCT07550569
Effectiveness of High Intensity Laser Therapy in Management of Lumbar Disc Herniation
A study testing Hiltherapy and physiotherapy in people with Lomber Disc Herniation, run by Baskent University at 3 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lomber Disc Herniation
- What is being tested?
- Hiltherapy and physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 May 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- History of Previous lumbar surgery
- Pregnancy
- Pacemaker
- Cognitive impairment or unwillingness to comply with treatment
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites
Baskent University
Ankara, Bahcelievler, 06490
Seyhan Sözay, Prof. dr., +903122237333, hastahaklari@baskent.edu.tr
Sevgi Ikbali Afşaar, Prof Dr., +905388868596, hastahaklari@baskent.edu.tr
Baskent University
Ankara, 06490
Sevgi İkbali Afşar, prof dr., ikbaliafsar@hotmail.com
Ozlem Kuculmez, Asist Prof Dr., +905555620521, akanozlem07@gmail.com
Başkent University Ankara Hospital
Ankara, 06490
Sevgi Ikbali Afsar, +905388868596, ikbaliafsar@hotmail.com
About this study
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.
Read the detailed description
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.
- Conditions
- Lomber Disc Herniation
- Being tested
- Hiltherapy, physiotherapy
- Keywords
- Intervertebral Disc Displacement, Back Pain, Laser Therapy
- Medical subject headings
- Intervertebral Disc Displacement, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiltherapyDevice
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.
physiotherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Hiltherapy |
| 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). Receives: Device: physiotherapy |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
• 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lomber Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sevgi İkbali Afşar, Prof. Dr., Study director, BASKENT UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550569
- Sponsor's protocol ID
- KA25/356
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For participants privacy
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Intensity Laser Therapy in Management of Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT07550569
- Acronym / sponsor ID
- KA25/356
- Conditions
- Lomber Disc Herniation
- Keywords
- Intervertebral Disc Displacement, Back Pain, Laser Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| hiltherapy | Experimental | Device: HiltherapyIn 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). |
| Physiotherapy | Active comparator | Device: physiotherapyUS + 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). |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- History of Fibromyalgia diagnosis
- History of acute trauma
- History of Lumbar instability
- History of Rheumatologic disease
- Motor deficits or myelopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HiltherapyNd: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. | Device | hiltherapy |
| physiotherapyCombination 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. | Device | Physiotherapy |
Primary outcome
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.
2 secondary outcomes
• Functional disability via Oswestry Disability Index
Time frame: 3 months
Short form-36
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No. For participants privacy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sevgi İkbali Afşar, Prof. Dr. study director
BASKENT UNİVERSİTY
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hiltherapy and physiotherapy in people with Lomber Disc Herniation, run by Baskent University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ozlem Kuculmez, assist prof dr (+905556205210, ahmedzmm@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.