Cervical Disc HerniationNCT05474625
Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation
A study testing High Intensity Laser Therapy, Ultrasound and Transcutaneous nerve stimulation (TENS) in people with Cervical Disc Herniation, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
Trial summary
The worldwide prevalence of neck pain is between 16.7-75.1%, it has been seen at an increasing rate in recent years due to sedentary living conditions. Pharmacological treatment, neck collar, traction, manual therapy, interventional injection techniques, surgical treatment and conventional physical therapy methods… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Disc Herniation
- What is being tested?
- High Intensity Laser Therapy, Ultrasound and Transcutaneous nerve stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2022to 1 Aug 2023
- 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 with cervical disc herniation diagnosed by MRI whose symptoms started for at least 3 months ago
- Not receiving physical therapy and rehabilitation in the last 3 months
- Not taking any medications such as analgesics, anti-inflammatoires or muscle relaxants for the treatment of symptoms.
Who cannot join
- patients with major psychiatric disease, cervical spine surgery and rheumatological disease; pacemaker users; those who were injected with local corticosteroids; pregnant women; cancer patients
Trial locations and contacts
1 site in 1 country.
About this study
The worldwide prevalence of neck pain is between 16.7-75.1%, it has been seen at an increasing rate in recent years due to sedentary living conditions.
Pharmacological treatment, neck collar, traction, manual therapy, interventional injection techniques, surgical treatment and conventional physical therapy methods such as hotpack, ultrasound, TENS (Transcutaneous electrical nerve stimulation), vacuum interference, exercise are applied in the treatment of neck pain.
Read more
In recent years, High Intensity Laser Therapy (HILT) has been used as a painless and non-invasive physical therapy agent. It received FDA approval in 2002 for HILT in the treatment of variety of musculoskeletal disorders.
There are a few studies in the literature investigating the efficacy of HILT in chronic neck pain. There is only one study investigating the efficacy of HILT in cervical disc herniation. In this study, the efficacy of HILT and ultrasound-TENS in the treatment of neck pain caused by cervical disc herniation has been compared, but the results of the exercise control group and long-term follow-up were not available.
The aim of this randomized controlled trial is to evaluate the short and long-term efficacy of HILT treatment using improvement in the pain, range of motion, activities of daily living and functionality of the cervical spine in patients with cervical disc herniation. In group 1, only exercises will be applied; in the group 2, HILT will be applied in addition to exercise; in the group 3, hotpack, TENS, ultrasound will be applied in addition to exercises.
- Conditions
- Cervical Disc Herniation
- Being tested
- High Intensity Laser Therapy, Ultrasound, Transcutaneous nerve stimulation (TENS), Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Laser TherapyDevice
For each 25 cm² of painful area, 1.02 minutes of treatment will give in the analgesic phase, with an energy of 8.0 watt, a dose of 5 Joules/ cm², a frequency of 25 Hertz(Hz) and a total energy of 125 joules. The application time for one session was approximately 15 minutes. Total 15 sessions will be applied to the neck area for a period of 3 weeks, 5 days a week.
UltrasoundDevice
This treatment was applied to the cervical paravertebral region with a direct contact with the skin with the aid of an ultrasonic gel, at a dose of 1 megahertz(MHz) and 1.5 Watt/cm² for 4 minutes
Transcutaneous nerve stimulation (TENS)Device
TENS was performed using 4 adhesive electrodes 5 × 5 cm size in the cervical paravertebral region, 80 Hertz (Hz) frequency and 180 miliseconds current for 20 minutes.
ExerciseOther
A specific program consisted of 15 minutes exercise sessions was provided under the supervision of a physiotherapist . All patients will perform isometric strengthening exercises, active range of motion exercises, and cervical region stretching exercises for 15 sessions (during 3 weeks, on weekdays).
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Active comparator | Only exercises Receives: Other: Exercise |
| High Intensity Laser Therapy(HILT) Group | Active comparator | Exercises+HILT Receives: Device: High Intensity Laser Therapy; Other: Exercise |
| Conventional Physiotherapy Group | Active comparator | Exercise+Hotpack+Transcutaneous nerve stimulation (TENS)+Ultrasound Receives: Device: Ultrasound; Device: Transcutaneous nerve stimulation (TENS); Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
Measured: Pre-treatment
Neck Disability Index
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
Measured: 1. month
Neck Disability Index
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
Measured: 3. month
Secondary outcomes (6)
Short Form Health Survey-36
A generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitation due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100.
Measured: pre-treatment
Short Form Health Survey-36
A generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitation due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100.
Measured: 1. months
Short Form Health Survey-36
A generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitation due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100.
Measured: 3. months
Visual Analog Scale
The Visual Analog Scale provides a subjective, visual linear pain score from 0 to 10 cm scored by the patient where 0 cm is no pain.
Measured: pre-treatment
Visual Analog Scale
The Visual Analog Scale provides a subjective, visual linear pain score from 0 to 10 cm scored by the patient where 0 cm is no pain.
Measured: 1. month
Visual Analog Scale
The Visual Analog Scale provides a subjective, visual linear pain score from 0 to 10 cm scored by the patient where 0 cm is no pain.
Measured: 3. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start30 Aug 2022
- Primary completion1 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şükran Güzel, Baskent University Ankara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474625
- Sponsor's protocol ID
- E-946003339-604.01.02-38865
- Status last verified
- Aug 2023
- First submitted
- 13 Jul 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation
- ClinicalTrials.gov ID
- NCT05474625
- Acronym / sponsor ID
- E-946003339-604.01.02-38865
- Conditions
- Cervical Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 26 Jul 2022 (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 worldwide prevalence of neck pain is between 16.7-75.1%, it has been seen at an increasing rate in recent years due to sedentary living conditions.
Pharmacological treatment, neck collar, traction, manual therapy, interventional injection techniques, surgical treatment and conventional physical therapy methods such as hotpack, ultrasound, TENS (Transcutaneous electrical nerve stimulation), vacuum interference, exercise are applied in the treatment of neck pain.
In recent years, High Intensity Laser Therapy (HILT) has been used as a painless and non-invasive physical therapy agent. It received FDA approval in 2002 for HILT in the treatment of variety of musculoskeletal disorders.
There are a few studies in the literature investigating the efficacy of HILT in chronic neck pain. There is only one study investigating the efficacy of HILT in cervical disc herniation. In this study, the efficacy of HILT and ultrasound-TENS in the treatment of neck pain caused by cervical disc herniation has been compared, but the results of the exercise control group and long-term follow-up were not available.
The aim of this randomized controlled trial is to evaluate the short and long-term efficacy of HILT treatment using improvement in the pain, range of motion, activities of daily living and functionality of the cervical spine in patients with cervical disc herniation. In group 1, only exercises will be applied; in the group 2, HILT will be applied in addition to exercise; in the group 3, hotpack, TENS, ultrasound will be applied in addition to exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Active comparator | Other: ExerciseOnly exercises |
| High Intensity Laser Therapy(HILT) Group | Active comparator | Device: High Intensity Laser Therapy, Other: ExerciseExercises+HILT |
| Conventional Physiotherapy Group | Active comparator | Device: Ultrasound, Device: Transcutaneous nerve stimulation (TENS), Other: ExerciseExercise+Hotpack+Transcutaneous nerve stimulation (TENS)+Ultrasound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with cervical disc herniation diagnosed by MRI whose symptoms started for at least 3 months ago
- Not receiving physical therapy and rehabilitation in the last 3 months
- Not taking any medications such as analgesics, anti-inflammatoires or muscle relaxants for the treatment of symptoms.
Key exclusion criteria (1 listed)
- patients with major psychiatric disease, cervical spine surgery and rheumatological disease; pacemaker users; those who were injected with local corticosteroids; pregnant women; cancer patients
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 TherapyFor each 25 cm² of painful area, 1.02 minutes of treatment will give in the analgesic phase, with an energy of 8.0 watt, a dose of 5 Joules/ cm², a frequency of 25 Hertz(Hz) and a total energy of 125 joules. The application time for one session was approximately 15 minutes. Total 15 sessions will be applied to the neck area for a period of 3 weeks, 5 days a week. | Device | High Intensity Laser Therapy(HILT) Group |
| UltrasoundThis treatment was applied to the cervical paravertebral region with a direct contact with the skin with the aid of an ultrasonic gel, at a dose of 1 megahertz(MHz) and 1.5 Watt/cm² for 4 minutes | Device | Conventional Physiotherapy Group |
| Transcutaneous nerve stimulation (TENS)TENS was performed using 4 adhesive electrodes 5 × 5 cm size in the cervical paravertebral region, 80 Hertz (Hz) frequency and 180 miliseconds current for 20 minutes. | Device | Conventional Physiotherapy Group |
| ExerciseA specific program consisted of 15 minutes exercise sessions was provided under the supervision of a physiotherapist . All patients will perform isometric strengthening exercises, active range of motion exercises, and cervical region stretching exercises for 15 sessions (during 3 weeks, on weekdays). | Other | Conventional Physiotherapy Group, Exercise Group, High Intensity Laser Therapy(HILT) Group |
Primary outcome
Neck Disability Index
Time frame: Pre-treatment
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
Neck Disability Index
Time frame: 1. month
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
Neck Disability Index
Time frame: 3. month
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
6 secondary outcomes
Short Form Health Survey-36
Time frame: pre-treatment
Short Form Health Survey-36
Time frame: 1. months
Short Form Health Survey-36
Time frame: 3. months
Visual Analog Scale
Time frame: pre-treatment
Visual Analog Scale
Time frame: 1. month
Visual Analog Scale
Time frame: 3. month
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 4 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Ultrasound and Transcutaneous nerve stimulation (TENS) in people with Cervical Disc Herniation, run by Baskent University Ankara Hospital 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 3 inclusion and 1 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 4 Aug 2023. 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. 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?
Neck Disability Index (time frame: Pre-treatment). The study lists 3 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 4 Aug 2023.