NCT04734977

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

Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy: A Randomized Study of Double Blınd With Sham Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Afyonkarahisar Health Sciences University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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. .

Conditions

• Radiculopathy
• Musculoskeletal Diseases
• Cervical Pain
• Cervical Radicular Pain
• Cervical Disc Disease

Interventions

Type	Name	Description
DEVICE	High-intensity laser therapy (HILT)	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.
DEVICE	Sham high-intensity laser therapy (Sham HILT)	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).
OTHER	Therapeutic Exercise	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2021-02-02
• Last updated: 2022-09-23

Locations

1 site across 1 country: Turkey (Türkiye)