Back to resultsComparison of the Different Exercises on Chronic Neck Pain
Primary Purpose
Neck Pain, Pain, Neck
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group 1
Group 2
Group 3
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
Inclusion Criteria:
- Chronic neck pain more than 3 months
- Medically stable
Exclusion Criteria:
- Patients with benign or tumors in the cervical region
- Patients with active, localized osseous and discal infection in the spine (spondylodiscitis)
- Patients with history of spinal fractures
- Patients with congenital anomaly
- Patients with neck surgery and spinal instability
Sites / Locations
- Eylül Pınar Kısa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Conventional training plus isometric neck exercises
Conventional training plus deep cervical flexor exercises
Conventional training plus stabilization exercises of the neck and core region
Outcomes
Primary Outcome Measures
Pain Intensity Assessment
The 11-point Verbal Numeric Pain Scale (VNPS; 0 means no pain; 10 means worst pain) will be use to assess pain intensity. The VNPS is a reliable and valid measure for subjective pain measurement. Participants will be asked to report the pain severity at that moment on a scale from 0 to 10.
Secondary Outcome Measures
Demografic Characteristic of Participants
The general demographic information of participants such as gender, age, body mass index will be recorded in a form created by investigators. Body mass index (BMI) values will be calculated by dividing body weights by the square of the height and be expressed in kg/m2.
Posture Evaluation
Reedco's posture score will be used in posture evaluation. The score is a standard tool and it is administered by visual inspection of 10 postural traits viewed laterally (sagittal view including neck, upper back, trunk, abdomen, and lower back) or from behind (coronal view including head, shoulders, spine, hips, and ankles). The scores are marked as follows: a value of 0 equals poor posture or severe deviation, a value of 5 equals fair posture or minimal to moderate deviation, and a value of 10 equals good posture or normal alignment. The maximum score of 100 indicates good posture and a score of 59% or less is recorded as postural dysfunction.
Evaluation of Cervical Range of Motion
Cervical ROM will be evaluated using a goniometer while the patient sitting on the chair with both feet on the ground. In the evaluation, after the goniometer is brought to the neutral position, the patient is asked to perform the desired movement with the head: flexion, extension, right and left lateral flexion, right and left rotation. A degree will be recorded for each neck motion and be used in the average analysis
Disability Evaluation
Neck Disability Index will be used to evaluate daily activities and ability. The form contains of 10 questions related to pain intensity, lifting, concentration, reading, headache, self-management, driving, working, sleeping, and daily activities. The score of each question is 0-5 according to the options and the total score is recorded by adding the scores of all answers. The lower the total score of the test, the less the effect of pain on performance in daily activities. The higher the score, the greater the performance of daily activities is affected.
Assessment of Quality of Life
The Short Form-36 is a test that includes a 36-item self-administered comprehensive health status questionnaire and will be used to assess the quality of life. This test includes questions evaluating physical function, social function, limitations due to physical health, limitations due to mental health, vitality, body pain, and general health. In this test, two scores are generally calculated, the combined physical and mental summary score. Higher scores indicate higher quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05488756
Brief Title
Comparison of the Different Exercises on Chronic Neck Pain
Official Title
Comparison of Three Different Exercise Training in Patients With Chronic Neck Pain: A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neck pain is a widespread problem in the general population and is second only to low back pain in musculoskeletal issues.
Detailed Description
The aim of this study is to compare the conventional therapy, cervical stabilization exercise approach, and core stabilization exercise in addiction to cervical stabilization in patients with chronic neck pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Pain, Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Conventional training plus isometric neck exercises
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Conventional training plus deep cervical flexor exercises
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Conventional training plus stabilization exercises of the neck and core region
Intervention Type
Other
Intervention Name(s)
Group 1
Intervention Description
Physical therapy agents and isometric exercise training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and isometric training 3 times a week for 4 weeks by the physical therapist.
Intervention Type
Other
Intervention Name(s)
Group 2
Intervention Description
Physical therapy agents and deep cervical flexor muscle training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and muscle training 3 times a week for 4 weeks by the physical therapist. Training of the craniocervical flexor muscles is going to be focused on the deep flexor muscles such as longus capitis and longus colli muscles, making neck flexion, not the head.
Intervention Type
Other
Intervention Name(s)
Group 3
Intervention Description
Physical therapy agents and core stabilization training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and stabilization training 3 times a week for 4 weeks by the physical therapist. These exercises will be performed for 10 repetitions with 10 seconds of contraction and 5 seconds of relaxation.
Primary Outcome Measure Information:
Title
Pain Intensity Assessment
Description
The 11-point Verbal Numeric Pain Scale (VNPS; 0 means no pain; 10 means worst pain) will be use to assess pain intensity. The VNPS is a reliable and valid measure for subjective pain measurement. Participants will be asked to report the pain severity at that moment on a scale from 0 to 10.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Demografic Characteristic of Participants
Description
The general demographic information of participants such as gender, age, body mass index will be recorded in a form created by investigators. Body mass index (BMI) values will be calculated by dividing body weights by the square of the height and be expressed in kg/m2.
Time Frame
1 week before the first treatment session
Title
Posture Evaluation
Description
Reedco's posture score will be used in posture evaluation. The score is a standard tool and it is administered by visual inspection of 10 postural traits viewed laterally (sagittal view including neck, upper back, trunk, abdomen, and lower back) or from behind (coronal view including head, shoulders, spine, hips, and ankles). The scores are marked as follows: a value of 0 equals poor posture or severe deviation, a value of 5 equals fair posture or minimal to moderate deviation, and a value of 10 equals good posture or normal alignment. The maximum score of 100 indicates good posture and a score of 59% or less is recorded as postural dysfunction.
Time Frame
4 weeks
Title
Evaluation of Cervical Range of Motion
Description
Cervical ROM will be evaluated using a goniometer while the patient sitting on the chair with both feet on the ground. In the evaluation, after the goniometer is brought to the neutral position, the patient is asked to perform the desired movement with the head: flexion, extension, right and left lateral flexion, right and left rotation. A degree will be recorded for each neck motion and be used in the average analysis
Time Frame
4 weeks
Title
Disability Evaluation
Description
Neck Disability Index will be used to evaluate daily activities and ability. The form contains of 10 questions related to pain intensity, lifting, concentration, reading, headache, self-management, driving, working, sleeping, and daily activities. The score of each question is 0-5 according to the options and the total score is recorded by adding the scores of all answers. The lower the total score of the test, the less the effect of pain on performance in daily activities. The higher the score, the greater the performance of daily activities is affected.
Time Frame
4 weeks
Title
Assessment of Quality of Life
Description
The Short Form-36 is a test that includes a 36-item self-administered comprehensive health status questionnaire and will be used to assess the quality of life. This test includes questions evaluating physical function, social function, limitations due to physical health, limitations due to mental health, vitality, body pain, and general health. In this test, two scores are generally calculated, the combined physical and mental summary score. Higher scores indicate higher quality of life.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic neck pain more than 3 months
Medically stable
Exclusion Criteria:
Patients with benign or tumors in the cervical region
Patients with active, localized osseous and discal infection in the spine (spondylodiscitis)
Patients with history of spinal fractures
Patients with congenital anomaly
Patients with neck surgery and spinal instability
Facility Information:
Facility Name
Eylül Pınar Kısa
City
İ̇stanbul
ZIP/Postal Code
34720
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Different Exercises on Chronic Neck Pain
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