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

NCT05852613 | Completed Phase 3 DMC

• 1 other identifier: Dina Ahmed Sherif Sherif
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Radiculopathy

Keywords

High power laser therapy; Cervical radiculopathy; Electrophysiological study; nerve conduction study; electromyography

Outcome Measures

Primary Outcomes (2)

• 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.

  before and after one month of treatment

• F wave

  for both median and ulnar nerves of both upper extremities

  before and after one month of treatment

Secondary Outcomes (2)

• nerve conduction studies (NCS)

  before and after one month of treatment

• electromyography (EMG)

  before and after one month of treatment

Study Arms (2)

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.

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 .

Combination Product: selected physical therapy program

Interventions

high power laser therapy (HPLT) 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.

Also known as: LEVELASER EZ1 EASYONE device

Group (A)

selected physical therapy program COMBINATION_PRODUCT

hot pack, US for 5 min, exercise for 20 min.

Group (A); Group (B)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Cairo, El Behoth, 12611, Egypt

Location

Related Publications (5)

• 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.

  PMID: 33902272 BACKGROUND

• 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.

  PMID: 26914684 BACKGROUND

• 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.

  PMID: 30443883 BACKGROUND

• 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.

  PMID: 23888293 BACKGROUND

• 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.

  PMID: 34733743 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ashraf A Darwish

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist at Al-Minshawy General Hospital

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 10, 2023
• Study Start: May 6, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 20, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)