RadiculopathyNCT04734977
Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy:
A study testing High-intensity laser therapy (HILT) and Therapeutic Exercise in people with Radiculopathy and Musculoskeletal Diseases, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This investigation aims to investigate the effect of high intensity laser therapy on radicular symptoms, neuropathic pain, cervical range of motion and quality of life in patients with cervical radiculopathy compared to cervical therapeutic exercises. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Radiculopathy, Musculoskeletal Diseases, Cervical Pain
- What is being tested?
- High-intensity laser therapy (HILT) and Therapeutic Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 22 Sep 2022
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy
- Inflammatory rheumatologic diseases
- Malignity
- Structural deformity
- Previous surgery related to the cervical spine
- Cervical spinal stenosis
Show all 10Show fewer
- Lokal corticosteroid injections
- Medications for neuropathic pain such as pregabalin or gabapentin
- Carpal tunnel syndrome, cubital tunnel syndrome
- Shoulder pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy: A Randomized Study of Double Blınd With Sham Control
This investigation aims to investigate the effect of high intensity laser therapy on radicular symptoms, neuropathic pain, cervical range of motion and quality of life in patients with cervical radiculopathy compared to cervical therapeutic exercises.
Read the detailed description
Most cases of cervical radiculopathy are due to cervical spondylosis or disc herniation. As the age progresses, disintegration of the disc causes a decrease in disc height and foraminal narrowing. The decreased disc height then results in hypertrophy due to vertebral loading in the intervertebral joints of Luschka. This leads to foraminal stenosis and cervical radiculopathy.If cervical radiculopathy is due to disc herniation, its mechanism is explained by the impact of the nerve root with the disc material and causing nerve damage by both mechanical and chemical effects.Non-operative treatment of cervical radiculopathy consists of a number of different modalities including immobilization, physical therapy, traction, manipulation,drug therapy, cervical steroid injection and laser therapy.The physiological effects of high intensity laser therapy(HILT) reduce the release of histamine and bradykinin from inflammatory tissue and increase the pain threshold. In addition, laser light reduces the secretion of substance P from peripheral nociceptors, thereby reducing the perception of pain and preventing the development of hyperalgesia. The laser analgesic effect is due to the increased secretion of endogenous opioids such as β-endorphins, where pain is centrally inhibited.
This investigation was designed double-blind prospective sham controlled randomized study. Participants were randomized into 3 groups: HILT + therapeutic exercise, sham HILT + therapeutic exercise, and only therapeutic exercise.
As evaluation parameters, cervical range of motion, Visual Pain Scale (VAS) Neck, Visual Pain Scale (VAS) Arm, SF (Short form) -36 Quality of Life Scale, Pain Detect Pain questionnaire, Cervical Radiculopathy Impact Scale ) will be evaluated with.It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the end of the treatment and at the 3rd month controls.
.
- Conditions
- Radiculopathy, Musculoskeletal Diseases, Cervical Pain, Cervical Radicular Pain, Cervical Disc Disease
- Being tested
- High-intensity laser therapy (HILT), Sham high-intensity laser therapy (Sham HILT), Therapeutic Exercise
- Keywords
- High Intensity Laser Therapy, Cervical Radicular Pain, Radiculopathy
- Medical subject headings
- Radiculopathy, Musculoskeletal Diseases, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity laser therapy (HILT)Device
High intensity laser therapy-Patients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of four weeks, and one session per day for a total of 20 sessions. A 3-phase treatment program was performed in each session.
Sham high-intensity laser therapy (Sham HILT)Device
Sham High intensity laser therapy was applied in five sessions a week for four weeks, with a total of 20 sessions a day, with no current flowing through the device using a HIRO 3 device (ASA Laser, Arcugnano, Italy).
Therapeutic ExerciseOther
As therapeutic exercise program; active cervical ROM, cervical isometric and progressive (self-exercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises.It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes.
Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| HILT+exercise | Experimental | Patients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of four weeks, and one session per day for a total of 20 sessions. A 3-phase treatment program was performed in each session, and the patients were then given a daily exercise program once a day by a physiotherapist. Receives: Device: High-intensity laser therapy (HILT); Other: Therapeutic Exercise |
| Sham HILT+exercise | Sham comparator | Sham therapy was applied in five sessions a week for four weeks, with a total of 20 sessions a day, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist. Receives: Device: Sham high-intensity laser therapy (Sham HILT); Other: Therapeutic Exercise |
| Exercise only | Active comparator | Exercise program was applied in five sessions a week for four weeks, with a total of 20 sessions a day. Receives: Other: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline visual analog scale (VAS) neck and arm pain at 4th and 12th week
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
Measured: up to 12th week
Secondary outcomes (5)
Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.
Measured: up to 12th week
Change from baseline range of motion of cervical spine measurements with goniometer at 4th and 12th weeks
cervical flexion, extension ,lateral flexion ,rotations(goniometric measurement results in units of degrees)
Measured: up to 12th week
Change from baseline Neck Dısabılıty Index (NDI) at 4th and 12th weeks
The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. Each question measures from 0 to 5, the total score out of 100 is calculated.
Measured: up to 12th week
Change from baseline Cervical Radiculopathy Impact Scale(CRIS) at 4th and 12th weeks
The Cervical Radiculopathy Impact Scale (CRIS) is developed a self-report questionnaire which covers the measurement of symptoms and limitations in patients with cervical radiculopathy due to irradiating pain, tingling sensations and sensory loss in the arm in combination with neck disability. It is divided into 3 subgroups as symptoms, energy\&posture and activities \&actions consist of 21 items. Every subgroup of the questionnaire has a score scale between 0 and 100 Each question measures from 0 to 5 is calculated. Higher scores mean worse outcome.
Measured: up to 12th week
Change from baseline Pain detect questionnaire (PD-Q) at 4th and 12th weeks
It's used to detect neuropathic pain components in chronic neck pain. It contains 2 items related to the spatial and temporal characteristics of the pain pattern and 7 sensory descriptive items. Minimum 0 and maximum of 38 points can be obtained. Higher scores mean worse outcome. PD-Q cut-off scores are ≤ 12 (a neuropathic component is unlikely) and ≥ 19 (a neuropathic component is likely).
Measured: up to 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Jan 2021
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RadiculopathyStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül İnce, Afyonkarahisar Health Sciences University
- Investigators
- Songül İNCE, MD, Principal investigator, Afyonkarahisar Health Sciences UniversityNuran EYVAZ, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734977
- Sponsor's protocol ID
- NEHILT2021
- Status last verified
- Sep 2022
- First submitted
- 25 Jan 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Konstantinovic LM, Cutovic MR, Milovanovic AN, Jovic SJ, Dragin AS, Letic MDj, Miler VM. Low-level laser therapy for acute neck pain with radiculopathy: a double-blind placebo-controlled randomized study. Pain Med. 2010 Aug;11(8):1169-78. doi: 10.1111/j.1526-4637.2010.00907.x.
PubMed 20704667Song HJ, Seo HJ, Lee Y, Kim SK. Effectiveness of high-intensity laser therapy in the treatment of musculoskeletal disorders: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Dec;97(51):e13126. doi: 10.1097/MD.0000000000013126.
PubMed 30572425Alayat MS, Mohamed AA, Helal OF, Khaled OA. Efficacy of high-intensity laser therapy in the treatment of chronic neck pain: a randomized double-blind placebo-control trial. Lasers Med Sci. 2016 May;31(4):687-94. doi: 10.1007/s10103-016-1910-2. Epub 2016 Feb 25.
PubMed 26914684
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy: A Randomized Study of Double Blınd With Sham Control
- ClinicalTrials.gov ID
- NCT04734977
- Acronym / sponsor ID
- NEHILT2021
- Conditions
- Radiculopathy, Musculoskeletal Diseases, Cervical Pain, Cervical Radicular Pain, Cervical Disc Disease
- Keywords
- High Intensity Laser Therapy, Cervical Radicular Pain, Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 2 Feb 2021 (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.
This investigation aims to investigate the effect of high intensity laser therapy on radicular symptoms, neuropathic pain, cervical range of motion and quality of life in patients with cervical radiculopathy compared to cervical therapeutic exercises.
Detailed description
Most cases of cervical radiculopathy are due to cervical spondylosis or disc herniation. As the age progresses, disintegration of the disc causes a decrease in disc height and foraminal narrowing. The decreased disc height then results in hypertrophy due to vertebral loading in the intervertebral joints of Luschka. This leads to foraminal stenosis and cervical radiculopathy.If cervical radiculopathy is due to disc herniation, its mechanism is explained by the impact of the nerve root with the disc material and causing nerve damage by both mechanical and chemical effects.Non-operative treatment of cervical radiculopathy consists of a number of different modalities including immobilization, physical therapy, traction, manipulation,drug therapy, cervical steroid injection and laser therapy.The physiological effects of high intensity laser therapy(HILT) reduce the release of histamine and bradykinin from inflammatory tissue and increase the pain threshold. In addition, laser light reduces the secretion of substance P from peripheral nociceptors, thereby reducing the perception of pain and preventing the development of hyperalgesia. The laser analgesic effect is due to the increased secretion of endogenous opioids such as β-endorphins, where pain is centrally inhibited.
This investigation was designed double-blind prospective sham controlled randomized study. Participants were randomized into 3 groups: HILT + therapeutic exercise, sham HILT + therapeutic exercise, and only therapeutic exercise.
As evaluation parameters, cervical range of motion, Visual Pain Scale (VAS) Neck, Visual Pain Scale (VAS) Arm, SF (Short form) -36 Quality of Life Scale, Pain Detect Pain questionnaire, Cervical Radiculopathy Impact Scale ) will be evaluated with.It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the end of the treatment and at the 3rd month controls.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HILT+exercise | Experimental | Device: High-intensity laser therapy (HILT), Other: Therapeutic ExercisePatients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of four weeks, and one session per day for a total of 20 sessions. A 3-phase treatment program was performed in each session, and the patients were then given a daily exercise program once a day by a physiotherapist. |
| Sham HILT+exercise | Sham comparator | Device: Sham high-intensity laser therapy (Sham HILT), Other: Therapeutic ExerciseSham therapy was applied in five sessions a week for four weeks, with a total of 20 sessions a day, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist. |
| Exercise only | Active comparator | Other: Therapeutic ExerciseExercise program was applied in five sessions a week for four weeks, with a total of 20 sessions a day. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Pregnancy
- Inflammatory rheumatologic diseases
- Malignity
- Structural deformity
- Previous surgery related to the cervical spine
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 therapy (HILT)High intensity laser therapy-Patients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of four weeks, and one session per day for a total of 20 sessions. A 3-phase treatment program was performed in each session. | Device | HILT+exercise |
| Sham high-intensity laser therapy (Sham HILT)Sham High intensity laser therapy was applied in five sessions a week for four weeks, with a total of 20 sessions a day, with no current flowing through the device using a HIRO 3 device (ASA Laser, Arcugnano, Italy). | Device | Sham HILT+exercise |
| Therapeutic ExerciseAs therapeutic exercise program; active cervical ROM, cervical isometric and progressive (self-exercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises.It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions. | Other | Exercise only, HILT+exercise, Sham HILT+exercise |
Primary outcome
Change from baseline visual analog scale (VAS) neck and arm pain at 4th and 12th week
Time frame: up to 12th week
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
5 secondary outcomes
Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks
Time frame: up to 12th week
Change from baseline range of motion of cervical spine measurements with goniometer at 4th and 12th weeks
Time frame: up to 12th week
Change from baseline Neck Dısabılıty Index (NDI) at 4th and 12th weeks
Time frame: up to 12th week
Change from baseline Cervical Radiculopathy Impact Scale(CRIS) at 4th and 12th weeks
Time frame: up to 12th week
Change from baseline Pain detect questionnaire (PD-Q) at 4th and 12th weeks
Time frame: up to 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Background: PubMed 20704667Konstantinovic LM, Cutovic MR, Milovanovic AN, Jovic SJ, Dragin AS, Letic MDj, Miler VM. Low-level laser therapy for acute neck pain with radiculopathy: a double-blind placebo-controlled randomized study. Pain Med. 2010 Aug;11(8):1169-78. doi: 10.1111/j.1526-4637.2010.00907.x.
- Background: PubMed 30572425Song HJ, Seo HJ, Lee Y, Kim SK. Effectiveness of high-intensity laser therapy in the treatment of musculoskeletal disorders: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Dec;97(51):e13126. doi: 10.1097/MD.0000000000013126.
- Background: PubMed 26914684Alayat MS, Mohamed AA, Helal OF, Khaled OA. Efficacy of high-intensity laser therapy in the treatment of chronic neck pain: a randomized double-blind placebo-control trial. Lasers Med Sci. 2016 May;31(4):687-94. doi: 10.1007/s10103-016-1910-2. Epub 2016 Feb 25.
- Individual participant dataSharing planned: No
Related trials for Radiculopathy
Recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy
Cervical Radiculopathy
Active, not recruiting
Comparative Effects of Kinetic Control Training and Neural Mobilization in Lumbar Radiculopathy
Lumbar Radiculopathy
RecruitingPhase 3
Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radiculopathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
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.
Songül İNCE, MD principal investigator
Afyonkarahisar Health Sciences University
Nuran EYVAZ, MD principal investigator
Afyonkarahisar Health Sciences University
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 (HILT) and Therapeutic Exercise in people with Radiculopathy and Musculoskeletal Diseases, run by Afyonkarahisar Health Sciences University 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 0 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: finished, as of the sponsor's last update on 23 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline visual analog scale (VAS) neck and arm pain at 4th and 12th week (time frame: up to 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734977, which also lists 3 linked publications.
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 23 Sep 2022.