Clinical trial NCT04734977: 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
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy
Musculoskeletal Diseases
Cervical Pain
Cervical Radicular Pain
Cervical Disc Disease
Keywords: High Intensity Laser Therapy
Cervical Radicular Pain
Radiculopathy
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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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

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

Primary outcomes:
measure: Change from baseline visual analog scale (VAS) neck and arm pain at 4th and 12th week
timeFrame: up to 12th week
Secondary outcomes:
measure: Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks
timeFrame: up to 12th week
measure: Change from baseline range of motion of cervical spine measurements with goniometer at 4th and 12th weeks
timeFrame: up to 12th week
measure: Change from baseline Neck Dısabılıty Index (NDI) at 4th and 12th weeks
timeFrame: up to 12th week
measure: Change from baseline Cervical Radiculopathy Impact Scale(CRIS) at 4th and 12th weeks
timeFrame: up to 12th week
measure: Change from baseline Pain detect questionnaire (PD-Q) at 4th and 12th weeks
timeFrame: up to 12th week
Other outcomes:
Locations:
city: Afyon
country: Turkey
facility: AFYON
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Songül İNCE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar Health Sciences University
name: Nuran EYVAZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.