Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation

Not Applicable

Completed

• Conditions: Cervical Disc Herniation
• Interventions: Device: Ultrasound; Other: Exercise; Device: High Intensity Laser Therapy; Device: Transcutaneous nerve stimulation (TENS)

• Registration Number: NCT05474625
• Lead Sponsor: Baskent University Ankara Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-24
• Study First Posted: 2022-07-26
• Study Start: 2022-08-30
• Primary Completion: 2023-06-01
• Status Verified: 2023-08
• Study Completion: 2023-08-01
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Physiotherapy Group	Ultrasound	Exercise+Hotpack+Transcutaneous nerve stimulation (TENS)+Ultrasound
Exercise Group	Exercise	Only exercises
High Intensity Laser Therapy(HILT) Group	High Intensity Laser Therapy	Exercises+HILT
High Intensity Laser Therapy(HILT) Group	Exercise	Exercises+HILT
Conventional Physiotherapy Group	Transcutaneous nerve stimulation (TENS)	Exercise+Hotpack+Transcutaneous nerve stimulation (TENS)+Ultrasound
Conventional Physiotherapy Group	Exercise	Exercise+Hotpack+Transcutaneous nerve stimulation (TENS)+Ultrasound

Primary Outcome Measures

Name	Time	Method
Neck Disability Index	3. month	This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result

Secondary Outcome Measures

Name	Time	Method
Short Form Health Survey-36	3. months	A generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitation due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= \[(actual raw score- lowest possible raw score)/possible raw score range\]100.
Visual Analog Scale	3. month	The Visual Analog Scale provides a subjective, visual linear pain score from 0 to 10 cm scored by the patient where 0 cm is no pain.

Trial Locations

Locations (1)

Baskent University Ankara Hospital; 🇹🇷 Ankara, Turkey