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

NCT05474625 | Completed

• 1 other identifier: E-946003339-604.01.02-38865
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Disc Herniation

Outcome Measures

Primary Outcomes (3)

• Neck Disability Index

  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

  Pre-treatment

• Neck Disability Index

  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

  1. month

• Neck Disability Index

  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

  3. month

Secondary Outcomes (6)

• Short Form Health Survey-36

  pre-treatment

• Short Form Health Survey-36

  1. months

• Short Form Health Survey-36

  3. months

• Visual Analog Scale

  pre-treatment

• Visual Analog Scale

  1. month

Study Arms (3)

Exercise Group

ACTIVE COMPARATOR

Only exercises

Other: Exercise

High Intensity Laser Therapy(HILT) Group

ACTIVE COMPARATOR

Exercises+HILT

Device: High Intensity Laser Therapy; Other: Exercise

Conventional Physiotherapy Group

ACTIVE COMPARATOR

Exercise+Hotpack+Transcutaneous nerve stimulation (TENS)+Ultrasound

Device: Ultrasound; Device: Transcutaneous nerve stimulation (TENS); Other: Exercise

Interventions

High Intensity Laser Therapy DEVICE

For each 25 cm² of painful area, 1.02 minutes of treatment will give in the analgesic phase, with an energy of 8.0 watt, a dose of 5 Joules/ cm², a frequency of 25 Hertz(Hz) and a total energy of 125 joules. The application time for one session was approximately 15 minutes. Total 15 sessions will be applied to the neck area for a period of 3 weeks, 5 days a week.

High Intensity Laser Therapy(HILT) Group

Ultrasound DEVICE

This treatment was applied to the cervical paravertebral region with a direct contact with the skin with the aid of an ultrasonic gel, at a dose of 1 megahertz(MHz) and 1.5 Watt/cm² for 4 minutes

Conventional Physiotherapy Group

Transcutaneous nerve stimulation (TENS) DEVICE

TENS was performed using 4 adhesive electrodes 5 × 5 cm size in the cervical paravertebral region, 80 Hertz (Hz) frequency and 180 miliseconds current for 20 minutes.

Conventional Physiotherapy Group

Exercise OTHER

A specific program consisted of 15 minutes exercise sessions was provided under the supervision of a physiotherapist . All patients will perform isometric strengthening exercises, active range of motion exercises, and cervical region stretching exercises for 15 sessions (during 3 weeks, on weekdays).

Conventional Physiotherapy Group; Exercise Group; High Intensity Laser Therapy(HILT) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Baskent University Ankara Hospital: lead

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Ultrasonography; Transcutaneous Electric Nerve Stimulation; Exercise

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 26, 2022
• Study Start: August 30, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

TU (1)