Cervical RadiculopathyPhase 3NCT05852613
Effect of HPLT on Pain and Electrophysiological Study in Cervical Radiculopathy Patients
A Phase 3 study testing high power laser therapy (HPLT) and selected physical therapy program in people with Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is : To determine the effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy. The main question it aims to answer : Is there a significant effect of high power laser therapy (HPLT) on pain and electrophysiological study in… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- high power laser therapy (HPLT) and selected physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 6 May 2023to 20 Jul 2023
- Phase
- Phase 3
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Twenty patients with unilateral cervical radiculopathy due to disc prolapse at the level of C5 - C6 or C6 - C7.
- Age ranges from 30 to 50 years.
- Patients will be both sexes.
- Patients will be diagnosed by clinical and radiological examination.
- Presence of sensory changes as pain and paresthesia (numbness, tingling, burning) in the upper extremity.
- Pain severity should be moderate or severe.
- Reporting a minimum pain score of 4 on a 10-point Visual Analogue Scale (VAS).
- Duration of pain ranges from (3-12) months.
Who cannot join
- Diabetic patient.
- Patients with peripheral neuropathy or entrapment syndrome.
- Previous cervical or shoulder surgery.
- Fracture of the bones of upper extremity.
- Major neurological condition (e.g., stroke, multiple sclerosis, Epilepsy, Meningitis, and Brain tumor).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy Cairo University
Cairo, El Behoth, 12611
About this study
Official title: Effect of High Power Laser Therapy on Pain and Electrophysiological Study in Cervical Radiculopathy Patients: Randomized Controlled Trial
The goal of this clinical trial is :
To determine the effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy.
Read more
The main question it aims to answer :
Is there a significant effect of high power laser therapy (HPLT) on pain and electrophysiological study in patients with cervical radiculopathy?
Twenty patients with cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7 will randomly assigned into two equal matched groups;
- group A (study group) N=10: this group will receive high power laser therapy (HPLT) for 8 minutes in addition to selected physical therapy program
- group B (control group) N=10: this group will receive the same selected physical therapy program only (hot pack, US for 5 min, exercise for 20 min) for 8 session.
All patients will attend the physical therapy clinic two times weekly for 4 weeks.
The evaluation was done by nerve conduction study (NCS) and needle electromyography (EMG) before and after the treatment in addition to visual analogue scale (VAS).
HYPOTHESES:
Null hypothesis: There is no significant effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy.
Read the detailed description
This current study will be designed to determine the effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy. This study will be carried out at outpatient clinic of Faculty of Physical Therapy, Cairo University.
Twenty patients with cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7 cervical radiculopathy will be selected from outpatient clinic of Faculty of Physical Therapy, Cairo University and outpatient clinic of Qasr El- Aini Hospitals.
On approval to participate in the study, all subjects will sign an informed consent form after receiving full information on the purpose of study, procedure, possible benefits, privacy and use of data, and their rights to withdraw from the study whenever they want.
Sample size:
Sample size calculation is performed using G*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) and revealed that the required sample size for this study is N=20.
Statistical analysis
- Descriptive statistics in form of mean, standard deviation and frequency will be conducted for the subject's demographics and collected data.
- Paired samples T Test procedure will be used to compare the means of two variables for a single group.
- Independent sample T Test Procedure will be used to compares means for two groups.
- Pearson Correlation Coefficient will be conducted to determine the correlation between electrophysiological study and pain intensity.
- The level of significance for all statistical tests will be set at p < 0.05.
- All statistical tests will be performed through the statistical package for social studies (SPSS) version 25 for windows. (IBM SPSS, Chicago, IL, USA).
- Conditions
- Cervical Radiculopathy
- Being tested
- high power laser therapy (HPLT), selected physical therapy program
- Keywords
- High power laser therapy, Cervical radiculopathy, Electrophysiological study, nerve conduction study, electromyography
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high power laser therapy (HPLT)Device
Also called LEVELASER EZ1 EASYONE device
high power laser therapy (HPLT) will be produced by A LEVELASER EZ1 EASYONE device which produces a Ga Al As CW diode laser with pulsed emission 980 nm and maximum average power 5 W with a high level of energy penetration. While the patient is in a prone position and the head slightly bends to the front, The treatment will be performed at a distance of 60-70 cm, perpendicular to the cervical region, in a pulsed mode of 4 Hz, wavelength = 980 nm, radiation power density P = 4 W in the scan phase and 2 W in the acupuncture phase and energy 840 J. Patients will receive pulsed HPLT laser treatment for 8 minutes. Scanning will be performed transversely and longitudinally to the bilateral paraspinal muscles, inter-scapular area, upper trapezius and the neck region for 6 minutes followed by 2 minutes acupuncture. Protective goggles will be used to prevent direct eye contact of the laser beam.
selected physical therapy programCombination product
hot pack, US for 5 min, exercise for 20 min.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | this group will receive high power laser therapy (HPLT) for 15 minutes in addition to selected physical therapy program for 8 session two times weekly for 4 weeks. Receives: Device: high power laser therapy (HPLT); Combination Product: selected physical therapy program |
| Group (B) | Active comparator | this group will receive the same selected physical therapy program only for 8 session.
All patients will attended the physical therapy clinic two times weekly for 4 weeks . Receives: Combination Product: selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain severity
using a 0-10 cm visual analog scale (VAS). Patients were asked to make a handwritten mark on a 100 mm line (10cm). This line represents a continuum between no pain or discomfort (zero), to the worst pain (10) that the patient could feel. The measure was taken by a ruler from the starting point of the scale to the mark the patient scored in millimeters.
The results were interpreted as: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm), (Jensen 2003). Patients should have moderate to severe neck pain to be included in the study. The pain intensity was recorded before and after the study.
Measured: before and after one month of treatment
F wave
for both median and ulnar nerves of both upper extremities
Measured: before and after one month of treatment
Secondary outcomes (2)
nerve conduction studies (NCS)
for both median and ulnar nerves of both upper extremities
Measured: before and after one month of treatment
electromyography (EMG)
using a bipolar needle electrode to biceps brachii, triceps and first dorsal interosseus muscles of both upper extremities.
Measured: before and after one month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start6 May 2023
- Primary completion1 Jun 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The current study will include twenty patients with unilateral cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7. Patients will be diagnosed on the basis of clinical (history and physical examination) and radiological examination (MRI). All subjects will be evaluated using the same procedures. \- Patients will be randomly assigned into two equal matched groups Group (A) study group: (N=10) this group will receive high power laser therapy (HPLT) for 15 minutes in addition to selected physical therapy program (hot pack, US for 5 min, exercise for 20min) for 8 session two times weekly for 4 weeks. Group (B) control group: (N=10) this group will receive the same selected physical therapy program only (hot pack,US for 5 min, exercise for 20 min) for 8 session. All patients will attended the physical therapy clinic two times weekly for 4 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ahmed Sherif Sherif, Cairo University
- Investigators
- Ashraf A Darwish, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852613
- Sponsor's protocol ID
- Dina Ahmed Sherif Sherif
- Status last verified
- Aug 2023
- First submitted
- 27 Apr 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barassi G, Supplizi M, Prosperi L, Irace G, Younes A, Della Rovere M, Rabini A, Colombo A, Di Iorio A. Dual-wavelength high-power laser therapy and neuromuscular manual therapy in chronic neck pain: a randomized clinical trial. J Biol Regul Homeost Agents. 2021 Mar-Apr;35(2):767-773. doi: 10.23812/21-37-L. No abstract available.
PubMed 33902272Alayat 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 26914684Venosa M, Romanini E, Padua R, Cerciello S. Comparison of high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation in patients with cervical spondylosis: a randomized controlled trial. Lasers Med Sci. 2019 Jul;34(5):947-953. doi: 10.1007/s10103-018-2682-7. Epub 2018 Nov 15.
PubMed 30443883Conforti M, Fachinetti GP. High power laser therapy treatment compared to simple segmental physical rehabilitation in whiplash injuries (1 degrees and 2 degrees grade of the Quebec Task Force classification) involving muscles and ligaments. Muscles Ligaments Tendons J. 2013 Jul 9;3(2):106-11. doi: 10.11138/mltj/2013.3.2.106. Print 2013 Apr.
PubMed 23888293Kenareh R, Mirmohammadi SJ, Khatibi A, Shamsi F, Mehrparvar AH. The Comparison of The Efficacy of Photobiomodulation and Ultrasound in the Treatment of Chronic Non-specific Neck Pain: A Randomized Single-Blind Controlled Trial. J Lasers Med Sci. 2021 May 17;12:e20. doi: 10.34172/jlms.2021.20. eCollection 2021.
PubMed 34733743
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Power Laser Therapy on Pain and Electrophysiological Study in Cervical Radiculopathy Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05852613
- Acronym / sponsor ID
- Dina Ahmed Sherif Sherif
- Conditions
- Cervical Radiculopathy
- Keywords
- High power laser therapy, Cervical radiculopathy, Electrophysiological study, nerve conduction study, electromyography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 10 May 2023 (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 goal of this clinical trial is :
To determine the effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy.
The main question it aims to answer :
Is there a significant effect of high power laser therapy (HPLT) on pain and electrophysiological study in patients with cervical radiculopathy?
Twenty patients with cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7 will randomly assigned into two equal matched groups;
- group A (study group) N=10: this group will receive high power laser therapy (HPLT) for 8 minutes in addition to selected physical therapy program
- group B (control group) N=10: this group will receive the same selected physical therapy program only (hot pack, US for 5 min, exercise for 20 min) for 8 session.
All patients will attend the physical therapy clinic two times weekly for 4 weeks.
The evaluation was done by nerve conduction study (NCS) and needle electromyography (EMG) before and after the treatment in addition to visual analogue scale (VAS).
HYPOTHESES:
Null hypothesis: There is no significant effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy.
Detailed description
This current study will be designed to determine the effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy. This study will be carried out at outpatient clinic of Faculty of Physical Therapy, Cairo University.
Twenty patients with cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7 cervical radiculopathy will be selected from outpatient clinic of Faculty of Physical Therapy, Cairo University and outpatient clinic of Qasr El- Aini Hospitals.
On approval to participate in the study, all subjects will sign an informed consent form after receiving full information on the purpose of study, procedure, possible benefits, privacy and use of data, and their rights to withdraw from the study whenever they want.
Sample size:
Sample size calculation is performed using G*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) and revealed that the required sample size for this study is N=20.
Statistical analysis
- Descriptive statistics in form of mean, standard deviation and frequency will be conducted for the subject's demographics and collected data.
- Paired samples T Test procedure will be used to compare the means of two variables for a single group.
- Independent sample T Test Procedure will be used to compares means for two groups.
- Pearson Correlation Coefficient will be conducted to determine the correlation between electrophysiological study and pain intensity.
- The level of significance for all statistical tests will be set at p < 0.05.
- All statistical tests will be performed through the statistical package for social studies (SPSS) version 25 for windows. (IBM SPSS, Chicago, IL, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The current study will include twenty patients with unilateral cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7. Patients will be diagnosed on the basis of clinical (history and physical examination) and radiological examination (MRI). All subjects will be evaluated using the same procedures. - Patients will be randomly assigned into two equal matched groups Group (A) study group: (N=10) this group will receive high power laser therapy (HPLT) for 15 minutes in addition to selected physical therapy program (hot pack, US for 5 min, exercise for 20min) for 8 session two times weekly for 4 weeks. Group (B) control group: (N=10) this group will receive the same selected physical therapy program only (hot pack,US for 5 min, exercise for 20 min) for 8 session. All patients will attended the physical therapy clinic two times weekly for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Device: high power laser therapy (HPLT), Combination Product: selected physical therapy programthis group will receive high power laser therapy (HPLT) for 15 minutes in addition to selected physical therapy program for 8 session two times weekly for 4 weeks. |
| Group (B) | Active comparator | Combination Product: selected physical therapy programthis group will receive the same selected physical therapy program only for 8 session. All patients will attended the physical therapy clinic two times weekly for 4 weeks . |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Twenty patients with unilateral cervical radiculopathy due to disc prolapse at the level of C5 - C6 or C6 - C7.
- Age ranges from 30 to 50 years.
- Patients will be both sexes.
- Patients will be diagnosed by clinical and radiological examination.
- Presence of sensory changes as pain and paresthesia (numbness, tingling, burning) in the upper extremity.
Key exclusion criteria (5 listed)
- Diabetic patient.
- Patients with peripheral neuropathy or entrapment syndrome.
- Previous cervical or shoulder surgery.
- Fracture of the bones of upper extremity.
- Major neurological condition (e.g., stroke, multiple sclerosis, Epilepsy, Meningitis, and Brain tumor).
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 power laser therapy (HPLT)Also: LEVELASER EZ1 EASYONE devicehigh power laser therapy (HPLT) will be produced by A LEVELASER EZ1 EASYONE device which produces a Ga Al As CW diode laser with pulsed emission 980 nm and maximum average power 5 W with a high level of energy penetration. While the patient is in a prone position and the head slightly bends to the front, The treatment will be performed at a distance of 60-70 cm, perpendicular to the cervical region, in a pulsed mode of 4 Hz, wavelength = 980 nm, radiation power density P = 4 W in the scan phase and 2 W in the acupuncture phase and energy 840 J. Patients will receive pulsed HPLT laser treatment for 8 minutes. Scanning will be performed transversely and longitudinally to the bilateral paraspinal muscles, inter-scapular area, upper trapezius and the neck region for 6 minutes followed by 2 minutes acupuncture. Protective goggles will be used to prevent direct eye contact of the laser beam. | Device | Group (A) |
| selected physical therapy programhot pack, US for 5 min, exercise for 20 min. | Combination product | Group (A), Group (B) |
Primary outcome
pain severity
Time frame: before and after one month of treatment
using a 0-10 cm visual analog scale (VAS). Patients were asked to make a handwritten mark on a 100 mm line (10cm). This line represents a continuum between no pain or discomfort (zero), to the worst pain (10) that the patient could feel. The measure was taken by a ruler from the starting point of the scale to the mark the patient scored in millimeters. The results were interpreted as: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm), (Jensen 2003). Patients should have moderate to severe neck pain to be included in the study. The pain intensity was recorded before and after the study.
F wave
Time frame: before and after one month of treatment
for both median and ulnar nerves of both upper extremities
2 secondary outcomes
nerve conduction studies (NCS)
Time frame: before and after one month of treatment
electromyography (EMG)
Time frame: before and after one month of treatment
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 29 Aug 2023.
- Background: PubMed 33902272Barassi G, Supplizi M, Prosperi L, Irace G, Younes A, Della Rovere M, Rabini A, Colombo A, Di Iorio A. Dual-wavelength high-power laser therapy and neuromuscular manual therapy in chronic neck pain: a randomized clinical trial. J Biol Regul Homeost Agents. 2021 Mar-Apr;35(2):767-773. doi: 10.23812/21-37-L. No abstract available.
- 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.
- Background: PubMed 30443883Venosa M, Romanini E, Padua R, Cerciello S. Comparison of high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation in patients with cervical spondylosis: a randomized controlled trial. Lasers Med Sci. 2019 Jul;34(5):947-953. doi: 10.1007/s10103-018-2682-7. Epub 2018 Nov 15.
- Background: PubMed 23888293Conforti M, Fachinetti GP. High power laser therapy treatment compared to simple segmental physical rehabilitation in whiplash injuries (1 degrees and 2 degrees grade of the Quebec Task Force classification) involving muscles and ligaments. Muscles Ligaments Tendons J. 2013 Jul 9;3(2):106-11. doi: 10.11138/mltj/2013.3.2.106. Print 2013 Apr.
- Background: PubMed 34733743Kenareh R, Mirmohammadi SJ, Khatibi A, Shamsi F, Mehrparvar AH. The Comparison of The Efficacy of Photobiomodulation and Ultrasound in the Treatment of Chronic Non-specific Neck Pain: A Randomized Single-Blind Controlled Trial. J Lasers Med Sci. 2021 May 17;12:e20. doi: 10.34172/jlms.2021.20. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Ashraf A Darwish study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing high power laser therapy (HPLT) and selected physical therapy program in people with Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.
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 8 inclusion and 5 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 29 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
pain severity (time frame: before and after one month of treatment). 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?
On the ClinicalTrials.gov record for NCT05852613, which also lists 5 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 29 Aug 2023.