- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05474625
Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Baskent University Ankara Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise Group
Only exercises
|
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).
|
Active Comparator: High Intensity Laser Therapy(HILT) Group
Exercises+HILT
|
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).
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.
|
Active Comparator: Conventional Physiotherapy Group
Exercise+Hotpack+Transcutaneous nerve stimulation (TENS)+Ultrasound
|
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).
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index
Time Frame: Pre-treatment
|
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
Time Frame: 1. 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
|
1. month
|
Neck Disability Index
Time Frame: 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
|
3. month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form Health Survey-36
Time Frame: pre-treatment
|
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.
|
pre-treatment
|
Short Form Health Survey-36
Time Frame: 1. 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.
|
1. months
|
Short Form Health Survey-36
Time Frame: 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.
|
3. months
|
Visual Analog Scale
Time Frame: pre-treatment
|
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.
|
pre-treatment
|
Visual Analog Scale
Time Frame: 1. 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.
|
1. month
|
Visual Analog Scale
Time Frame: 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.
|
3. month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-946003339-604.01.02-38865
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Disc Herniation
-
Holger JoswigCompletedLumbar Disc Herniation | Cervical Disc HerniationSwitzerland
-
Janbubi JandaulyetRecruitingCervical Disc Herniation | Cervical Radicular Pain | Facet TropismTurkey
-
William Beaumont HospitalsStryker SpineRecruitingDegenerative Disc Disease | Cervical Disc Herniation | Cervical Disc DegenerationUnited States
-
Samsun UniversityCompletedCervical Disc Disease | Cervical Disc Herniation | Cervical StenosisTurkey
-
Centre Hospitalier Régional de la CitadelleNot yet recruitingCervical Disc Herniation | Cervical Foraminal Stenosis
-
Marmara UniversityRecruiting
-
Jaseng Medical FoundationActive, not recruitingCervical Disc HerniationKorea, Republic of
-
Marmara UniversityCompletedCervical Disc HerniationTurkey
-
Yonsei UniversityCompletedCervical Disc Herniation | Cervical Spinal Stenosis | Cervical Spine DamageKorea, Republic of
-
Istanbul Medipol University HospitalCompletedPain | Cervical Radiculopathy | Cervical Disc Disease | Cervical Disc Herniation | Cervical Radicular Pain | Cervical; HerniaTurkey
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan
-
Wayne State UniversityUnknown