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Effect of HPLT on Pain and Electrophysiological Study in Cervical Radiculopathy Patients

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
high power laser therapy (HPLT)
selected physical therapy program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring High power laser therapy, Cervical radiculopathy, Electrophysiological study, nerve conduction study, electromyography

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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).

Sites / Locations

  • Faculty of Physical Therapy Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group (A)

Group (B)

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

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.
F wave
for both median and ulnar nerves of both upper extremities

Secondary Outcome Measures

nerve conduction studies (NCS)
for both median and ulnar nerves of both upper extremities
electromyography (EMG)
using a bipolar needle electrode to biceps brachii, triceps and first dorsal interosseus muscles of both upper extremities.

Full Information

First Posted
April 27, 2023
Last Updated
August 27, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05852613
Brief Title
Effect of HPLT on Pain and Electrophysiological Study in Cervical Radiculopathy Patients
Official Title
Effect of High Power Laser Therapy on Pain and Electrophysiological Study in Cervical Radiculopathy Patients: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 6, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
High power laser therapy, Cervical radiculopathy, Electrophysiological study, nerve conduction study, electromyography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group (B)
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Device
Intervention Name(s)
high power laser therapy (HPLT)
Other Intervention Name(s)
LEVELASER EZ1 EASYONE device
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
selected physical therapy program
Intervention Description
hot pack, US for 5 min, exercise for 20 min.
Primary Outcome Measure Information:
Title
pain severity
Description
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.
Time Frame
before and after one month of treatment
Title
F wave
Description
for both median and ulnar nerves of both upper extremities
Time Frame
before and after one month of treatment
Secondary Outcome Measure Information:
Title
nerve conduction studies (NCS)
Description
for both median and ulnar nerves of both upper extremities
Time Frame
before and after one month of treatment
Title
electromyography (EMG)
Description
using a bipolar needle electrode to biceps brachii, triceps and first dorsal interosseus muscles of both upper extremities.
Time Frame
before and after one month of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf A Darwish
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Cairo
State/Province
El Behoth
ZIP/Postal Code
12611
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33902272
Citation
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.
Results Reference
background
PubMed Identifier
26914684
Citation
Alayat 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.
Results Reference
background
PubMed Identifier
30443883
Citation
Venosa 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.
Results Reference
background
PubMed Identifier
23888293
Citation
Conforti 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.
Results Reference
background
PubMed Identifier
34733743
Citation
Kenareh 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.
Results Reference
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Effect of HPLT on Pain and Electrophysiological Study in Cervical Radiculopathy Patients

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