Lumbar RadiculopathyNCT06651775
Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation.
A study testing High intensity laser therapy in people with Lumbar Radiculopathy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- High intensity laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- Pregnancy
- Patients with cardiac pacemakers
- Patients with a diagnosis of inflammatory rheumatic disease,
- Patients with a diagnosis of polyneuropathy that precludes receiving treatment,
- Patients with active or history of malignancy within the last 1 year and currently receiving chemotherapy and/or radiotherapy,
- Patients with serious psychiatric illness,
Show all 17Show fewer
- Patients with severe coagulation disorders,
- Spinal Stenosis (patients with spinal canal diameter less than 8 mm)
- Patients with neurologic deficits that prevent them from receiving treatment,
- Patients with active infection,
- Patients with vasculitis,
- Patients with skin disease in the treated area,
- Patients who received steroid injections and/or physical therapy for the lumbar region within the last 3 months,
- Patients undergoing lumbar spine surgery,
- Patients with acute trauma,
- Patients with a history of lumbar instability,
- Patients with uncontrolled or severe cardiovascular or metabolic disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Cankaya, 06100
Ankara Bilkent City Hospital, +90 0312 552 60 00, ankarasehir@saglik.gov.tr
About this study
Official title: Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation
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:
Read more
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.
Read the detailed description
Efficacy of High Intensity Laser Therapy in Patients with Chronic Lumbar Radiculopathy Due to Disc Herniation , Ankara 2025
Low back pain is an important and widespread health problem that negatively affects the quality of life from past to present, causes deterioration in functional status and may cause disability and psychologically wears out human health in the chronic period. In epidemiological studies, the prevalence of low back pain has been found to be approximately 40% throughout life.
Low back pain is classified as acute, subacute and chronic according to its duration and as mechanical and inflammatory according to the character of the pain. Low back pain lasting more than 12 weeks is defined as chronic low back pain.
Etiological factors include fracture, malignancy, infection, trauma, osteoporosis, inflammatory diseases, myogenic causes, etc. One of the most important and common causes of mechanical causes is intervertebral disc herniation. Disc herniation may also cause radicular pain in the form of numbness, burning, electrification, pins and needles in the dermatome area of the related nerve due to neural root compression.
There are many treatment modalities for radicular low back pain due to lumbar disc herniation. These include medical treatment, lumbar and abdominal strengthening exercises given outside the acute painful period, physical therapy modalities, alternative medicine methods, laser therapy, epidural steroid injections and surgical treatment.
The term laser is defined as "light amplification by stimulated radiation emission". It is a non-invasive and painless treatment. There are two types of laser therapy, low and high intensity, with different intensity according to peak power and wavelength. Pulsed neodymium-doped yttrium aluminium garnet (Nd:YAG) high intensity laser, HILT, works with high peak power and 1.064nm wavelength. The laser has 5 basic mechanisms of action: thermal, mechanical, electrical, photochemical, biostimulate. Biostimulation, antiedema, analgesic and anti-inflammatory effects in the applied area are more pronounced due to its high intensity and specific wavelength, but the exact mechanism of action in reducing pain has not yet been clearly clarified.
This study, aimed to investigate the effects of high-intensity laser therapy (HILT) on the patient's disability, functionality, and neuropathic and nociceptive patterns of pain in radicular pain due to lumbar disc herniation in the chronic period and its superiority over the conventional electrotherapy modalities we frequently use. The study was designed as a randomised, placebo-controlled, double-blind, prospective study.
This study includes patients admitted to the outpatient clinics of Ankara City Hospital Physical Medicine and Rehabilitation Hospital who have low back pain radiating to the lower extremities for more than 12 weeks and have sensory deficit and/or pain sensation in dermatomal distribution due to radicular lesion accompanying lumbar disc herniation shown by lumbar MRI. Patients will be randomly divided into two groups.
A total of 70 patients aged 18-65 years of male and female sex will be included in the study and the patients will be randomly divided into two groups of equal number.
Patients in Group A (n:35) will receive 15 sessions of hotpack and 15 sessions of TENS (transcutaneous electrical nerve stimulation) five days a week for 3 weeks, 15 sessions of HIRO TT (ASA Laser, Arcugnano, Italy) device in lumbosciatica mode in three phases (fast scanning, trigger point, slow scanning) over an area of 25 cm². Isometric lumbar strengthening and core stabilisation exercises will be given to the patients as a home programme.
Patients in group B (n:35) will receive TENS (Transcutaneous Electrical Nerve Stimulation), Hotpack, Lumbar and Core Stabilisation Exercises and sham High Intensity Laser treatments and the protocols will be the same as in group A. Patients will be evaluated 3 times in total: pre-treatment, post-treatment and 3 months.
- Conditions
- Lumbar Radiculopathy
- Being tested
- High intensity laser therapy, Sham Comparator
- Keywords
- Activity of Daily Living, chronic low back pain, high intensity laser therapy, pain
- Medical subject headings
- Radiculopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity laser therapyDevice
lumbosciatalgia mode of the HILT device
Sham ComparatorDevice
sham mode of the HILT device
| Study group | Role | What they receive |
|---|---|---|
| HILT group | Experimental | Receiving Hotpack+TENS+Exercises+HILT Receives: Device: High intensity laser therapy |
| Sham group | Sham comparator | Receiving Hotpack+TENS+Exercises+ sham HILT Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-treatment, immediately post-treatment and three months follow-up
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.
Measured: pre-treatment, immediately post-treatment and three months follow-up
Secondary outcomes (2)
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.
Measured: pre-treatment, immediately post-treatment and three months follow-up
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.
Measured: pre-treatment, immediately post-treatment and three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start15 May 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talha Yılmaz, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651775
- Sponsor's protocol ID
- E2-24-6770
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only study protocol
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation
- ClinicalTrials.gov ID
- NCT06651775
- Acronym / sponsor ID
- E2-24-6770
- Conditions
- Lumbar Radiculopathy
- Keywords
- Activity of Daily Living, chronic low back pain, high intensity laser therapy, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
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.
Detailed description
Efficacy of High Intensity Laser Therapy in Patients with Chronic Lumbar Radiculopathy Due to Disc Herniation , Ankara 2025
Low back pain is an important and widespread health problem that negatively affects the quality of life from past to present, causes deterioration in functional status and may cause disability and psychologically wears out human health in the chronic period. In epidemiological studies, the prevalence of low back pain has been found to be approximately 40% throughout life.
Low back pain is classified as acute, subacute and chronic according to its duration and as mechanical and inflammatory according to the character of the pain. Low back pain lasting more than 12 weeks is defined as chronic low back pain.
Etiological factors include fracture, malignancy, infection, trauma, osteoporosis, inflammatory diseases, myogenic causes, etc. One of the most important and common causes of mechanical causes is intervertebral disc herniation. Disc herniation may also cause radicular pain in the form of numbness, burning, electrification, pins and needles in the dermatome area of the related nerve due to neural root compression.
There are many treatment modalities for radicular low back pain due to lumbar disc herniation. These include medical treatment, lumbar and abdominal strengthening exercises given outside the acute painful period, physical therapy modalities, alternative medicine methods, laser therapy, epidural steroid injections and surgical treatment.
The term laser is defined as "light amplification by stimulated radiation emission". It is a non-invasive and painless treatment. There are two types of laser therapy, low and high intensity, with different intensity according to peak power and wavelength. Pulsed neodymium-doped yttrium aluminium garnet (Nd:YAG) high intensity laser, HILT, works with high peak power and 1.064nm wavelength. The laser has 5 basic mechanisms of action: thermal, mechanical, electrical, photochemical, biostimulate. Biostimulation, antiedema, analgesic and anti-inflammatory effects in the applied area are more pronounced due to its high intensity and specific wavelength, but the exact mechanism of action in reducing pain has not yet been clearly clarified.
This study, aimed to investigate the effects of high-intensity laser therapy (HILT) on the patient's disability, functionality, and neuropathic and nociceptive patterns of pain in radicular pain due to lumbar disc herniation in the chronic period and its superiority over the conventional electrotherapy modalities we frequently use. The study was designed as a randomised, placebo-controlled, double-blind, prospective study.
This study includes patients admitted to the outpatient clinics of Ankara City Hospital Physical Medicine and Rehabilitation Hospital who have low back pain radiating to the lower extremities for more than 12 weeks and have sensory deficit and/or pain sensation in dermatomal distribution due to radicular lesion accompanying lumbar disc herniation shown by lumbar MRI. Patients will be randomly divided into two groups.
A total of 70 patients aged 18-65 years of male and female sex will be included in the study and the patients will be randomly divided into two groups of equal number.
Patients in Group A (n:35) will receive 15 sessions of hotpack and 15 sessions of TENS (transcutaneous electrical nerve stimulation) five days a week for 3 weeks, 15 sessions of HIRO TT (ASA Laser, Arcugnano, Italy) device in lumbosciatica mode in three phases (fast scanning, trigger point, slow scanning) over an area of 25 cm². Isometric lumbar strengthening and core stabilisation exercises will be given to the patients as a home programme.
Patients in group B (n:35) will receive TENS (Transcutaneous Electrical Nerve Stimulation), Hotpack, Lumbar and Core Stabilisation Exercises and sham High Intensity Laser treatments and the protocols will be the same as in group A. Patients will be evaluated 3 times in total: pre-treatment, post-treatment and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HILT group | Experimental | Device: High intensity laser therapyReceiving Hotpack+TENS+Exercises+HILT |
| Sham group | Sham comparator | Device: Sham ComparatorReceiving Hotpack+TENS+Exercises+ sham HILT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- Pregnancy
- Patients with cardiac pacemakers
- Patients with a diagnosis of inflammatory rheumatic disease,
- Patients with a diagnosis of polyneuropathy that precludes receiving treatment,
- Patients with active or history of malignancy within the last 1 year and currently receiving chemotherapy and/or radiotherapy,
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 |
|---|---|---|
| High intensity laser therapylumbosciatalgia mode of the HILT device | Device | HILT group |
| Sham Comparatorsham mode of the HILT device | Device | Sham group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: pre-treatment, immediately post-treatment and three months follow-up
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.
Revised Oswestry Disability Index (ODI)
Time frame: pre-treatment, immediately post-treatment and three months follow-up
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.
2 secondary outcomes
Nottingham Health Profile (NHP)
Time frame: pre-treatment, immediately post-treatment and three months follow-up
LANSS Pain Scale
Time frame: pre-treatment, immediately post-treatment and three months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: Yes. only study protocol
Related trials for Lumbar Radiculopathy
Active, not recruiting
Comparative Effects of Kinetic Control Training and Neural Mobilization in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Not yet recruiting
Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
Unilateral S1 Nerve Root Pain
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity laser therapy in people with Lumbar Radiculopathy, run by Ankara City Hospital Bilkent at 1 site 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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berke Aras, associated professor (+90 536585 1518, drberkearas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: pre-treatment, immediately post-treatment and three months follow-up). The study lists 2 primary outcomes in all. 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 26 Oct 2024.