search
Back to results

Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy:

Primary Purpose

Radiculopathy, Musculoskeletal Diseases, Cervical Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High-intensity laser therapy (HILT)
Sham high-intensity laser therapy (Sham HILT)
Therapeutic Exercise
Sponsored by
Afyonkarahisar Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy focused on measuring High Intensity Laser Therapy, Cervical Radicular Pain, Radiculopathy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Eligible patients aged 20-65 years old with pain in the cervical spine and arm pain with or without neck pain lasting for at least one month. Patients were included in the study

  1. radicular clinical symptoms
  2. cervical disc herniation and degenerative changes diagnosed with cervical MR
  3. radiculopathy findings on Electromyography (EMG) and Nerve Conduction Studies

Exclusion Criteria:

  1. Pregnancy
  2. Inflammatory rheumatologic diseases
  3. Malignity
  4. Structural deformity
  5. Previous surgery related to the cervical spine
  6. Cervical spinal stenosis
  7. Lokal corticosteroid injections
  8. Medications for neuropathic pain such as pregabalin or gabapentin
  9. Carpal tunnel syndrome, cubital tunnel syndrome
  10. Shoulder pathology

Sites / Locations

  • AFYON

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

HILT+exercise

Sham HILT+exercise

Exercise only

Arm Description

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.

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.

Exercise program was applied in five sessions a week for four weeks, with a total of 20 sessions a day.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
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.
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.
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).

Full Information

First Posted
January 25, 2021
Last Updated
September 22, 2022
Sponsor
Afyonkarahisar Health Sciences University
search

1. Study Identification

Unique Protocol Identification Number
NCT04734977
Brief Title
Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy:
Official Title
Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy: A Randomized Study of Double Blınd With Sham Control
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
September 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afyonkarahisar Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Musculoskeletal Diseases, Cervical Pain, Cervical Radicular Pain, Cervical Disc Disease
Keywords
High Intensity Laser Therapy, Cervical Radicular Pain, Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HILT+exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham HILT+exercise
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Exercise only
Arm Type
Active Comparator
Arm Description
Exercise program was applied in five sessions a week for four weeks, with a total of 20 sessions a day.
Intervention Type
Device
Intervention Name(s)
High-intensity laser therapy (HILT)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham high-intensity laser therapy (Sham HILT)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline visual analog scale (VAS) neck and arm pain at 4th and 12th week
Description
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.
Time Frame
up to 12th week
Secondary Outcome Measure Information:
Title
Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks
Description
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.
Time Frame
up to 12th week
Title
Change from baseline range of motion of cervical spine measurements with goniometer at 4th and 12th weeks
Description
cervical flexion, extension ,lateral flexion ,rotations(goniometric measurement results in units of degrees)
Time Frame
up to 12th week
Title
Change from baseline Neck Dısabılıty Index (NDI) at 4th and 12th weeks
Description
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.
Time Frame
up to 12th week
Title
Change from baseline Cervical Radiculopathy Impact Scale(CRIS) at 4th and 12th weeks
Description
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.
Time Frame
up to 12th week
Title
Change from baseline Pain detect questionnaire (PD-Q) at 4th and 12th weeks
Description
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).
Time Frame
up to 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible patients aged 20-65 years old with pain in the cervical spine and arm pain with or without neck pain lasting for at least one month. Patients were included in the study radicular clinical symptoms cervical disc herniation and degenerative changes diagnosed with cervical MR radiculopathy findings on Electromyography (EMG) and Nerve Conduction Studies Exclusion Criteria: Pregnancy Inflammatory rheumatologic diseases Malignity Structural deformity Previous surgery related to the cervical spine Cervical spinal stenosis Lokal corticosteroid injections Medications for neuropathic pain such as pregabalin or gabapentin Carpal tunnel syndrome, cubital tunnel syndrome Shoulder pathology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Songül İNCE, MD
Organizational Affiliation
Afyonkarahisar Health Sciences University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nuran EYVAZ, MD
Organizational Affiliation
Afyonkarahisar Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AFYON
City
Afyon
ZIP/Postal Code
03200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20704667
Citation
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.
Results Reference
background
PubMed Identifier
30572425
Citation
Song 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. Erratum In: Medicine (Baltimore). 2019 Jan;98(4):e14274.
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

Learn more about this trial

Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy:

We'll reach out to this number within 24 hrs