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

Afyonkarahisar Health Sciences University

Status: Completed

Conditions: Radiculopathy; Cervical Radicular Pain; Cervical Disc Disease; Cervical Pain; Musculoskeletal Diseases

Treatments: Device: High-intensity laser therapy (HILT); Device: Sham high-intensity laser therapy (Sham HILT); Other: Therapeutic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04734977

NEHILT2021

Details and patient eligibility

About

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.

Full 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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Enrollment: 90 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

HILT+exercise

Experimental group

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.

Treatment:

Other: Therapeutic Exercise

Device: High-intensity laser therapy (HILT)

Sham HILT+exercise

Sham Comparator group

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.

Treatment:

Other: Therapeutic Exercise

Device: Sham high-intensity laser therapy (Sham HILT)

Exercise only

Active Comparator group

Description:

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

Treatment:

Other: Therapeutic Exercise