Clinical trial NCT05474625: Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation
Official title: Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Disc Herniation
Lead sponsor: Baskent University Ankara Hospital
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The worldwide prevalence of neck pain is between 16.7-75.1%, it has been seen at an increasing rate in recent years due to sedentary living conditions.

Pharmacological treatment, neck collar, traction, manual therapy, interventional injection techniques, surgical treatment and conventional physical therapy methods such as hotpack, ultrasound, TENS (Transcutaneous electrical nerve stimulation), vacuum interference, exercise are applied in the treatment of neck pain.

In recent years, High Intensity Laser Therapy (HILT) has been used as a painless and non-invasive physical therapy agent. It received FDA approval in 2002 for HILT in the treatment of variety of musculoskeletal disorders.

There are a few studies in the literature investigating the efficacy of HILT in chronic neck pain. There is only one study investigating the efficacy of HILT in cervical disc herniation. In this study, the efficacy of HILT and ultrasound-TENS in the treatment of neck pain caused by cervical disc herniation has been compared, but the results of the exercise control group and long-term follow-up were not available.

The aim of this randomized controlled trial is to evaluate the short and long-term efficacy of HILT treatment using improvement in the pain, range of motion, activities of daily living and functionality of the cervical spine in patients with cervical disc herniation. In group 1, only exercises will be applied; in the group 2, HILT will be applied in addition to exercise; in the group 3, hotpack, TENS, ultrasound will be applied in addition to exercises.


Eligibility criteria: Inclusion Criteria:

* Patients with cervical disc herniation diagnosed by MRI whose symptoms started for at least 3 months ago
* Not receiving physical therapy and rehabilitation in the last 3 months
* Not taking any medications such as analgesics, anti-inflammatoires or muscle relaxants for the treatment of symptoms.

Exclusion Criteria:

* patients with major psychiatric disease, cervical spine surgery and rheumatological disease; pacemaker users; those who were injected with local corticosteroids; pregnant women; cancer patients

Primary outcomes:
measure: Neck Disability Index
timeFrame: Pre-treatment
measure: Neck Disability Index
timeFrame: 1. month
measure: Neck Disability Index
timeFrame: 3. month
Secondary outcomes:
measure: Short Form Health Survey-36
timeFrame: pre-treatment
measure: Short Form Health Survey-36
timeFrame: 1. months
measure: Short Form Health Survey-36
timeFrame: 3. months
measure: Visual Analog Scale
timeFrame: pre-treatment
measure: Visual Analog Scale
timeFrame: 1. month
measure: Visual Analog Scale
timeFrame: 3. month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
Study officials:
References: