- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05488756
Comparison of the Different Exercises on Chronic Neck Pain
September 20, 2022 updated by: Eylül Pınar KISA, Biruni University
Comparison of Three Different Exercise Training in Patients With Chronic Neck Pain: A Randomized Study
Neck pain is a widespread problem in the general population and is second only to low back pain in musculoskeletal issues.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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İ̇stanbul, Turkey, 34720
- Eylül Pınar Kısa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group 1
Conventional training plus isometric neck exercises
|
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.
|
EXPERIMENTAL: Group 2
Conventional training plus deep cervical flexor exercises
|
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.
|
EXPERIMENTAL: Group 3
Conventional training plus stabilization exercises of the neck and core region
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity Assessment
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demografic Characteristic of Participants
Time Frame: 1 week before the first treatment session
|
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.
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1 week before the first treatment session
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Posture Evaluation
Time Frame: 4 weeks
|
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.
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4 weeks
|
Evaluation of Cervical Range of Motion
Time Frame: 4 weeks
|
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
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4 weeks
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Disability Evaluation
Time Frame: 4 weeks
|
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.
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4 weeks
|
Assessment of Quality of Life
Time Frame: 4 weeks
|
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.
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4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 8, 2022
Primary Completion (ACTUAL)
September 9, 2022
Study Completion (ACTUAL)
September 16, 2022
Study Registration Dates
First Submitted
August 1, 2022
First Submitted That Met QC Criteria
August 3, 2022
First Posted (ACTUAL)
August 5, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 21, 2022
Last Update Submitted That Met QC Criteria
September 20, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neck Pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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