- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04691024
Remotely Spinal Stabilization Exercises in Individuals With Chronic Neck Pain
February 28, 2023 updated by: Dilara Onan, Hacettepe University
Effects of Remotely Applied Spinal Stabilization Exercises on Functional Level and Muscle Architecture in Individuals With Chronic Neck Pain
Neck pain is a problem that recurs at certain stages of life and can affect approximately half of the population.
A problem in the cervical region can cause problems such as pain and limitation in the surrounding joints.
Doing a job with functional activity or fulfilling professional requirements can aggravate neck pain.
As a result, anatomical, physiological and psychological systems emerge as factors affecting pain.
Determining the disability of the individual and the effectiveness of rehabilitation can be demonstrated with functional capacity assessment.
It is stated that in individuals with chronic neck pain, architectural features such as functional cross-sectional area of deep neck muscles and reduction of muscle thickness change.
Muscle preservation may increase as pain increases, and more protection too; Limitations can further increase conditions such as pain.
In addition to the problem being only in the neck region, the whole spine posture may change, and the lumbar region muscles may also weaken by considering the spine as a whole.
It is stated that the muscular architectural properties of the cervical and lumbar region, which play an important role in the posture of the spine in individuals with chronic neck pain, can be improved with exercise.
During the 2020 years' pandemic process, the time spent at home, the use of mobile devices, the duration of working at home on a desk increased, and increases in spine pain reported to professionals were observed.
The fact that family members are at home has increased the workload of the home and the frequency of performing functional activities has increased.
It is reported that the distance between physiotherapists and patients should be at least 2 meters in clinics due to the risk of contamination.
As a result, the pandemic process has brought the remote exercise management, tele-rehabilitation process to the fore for physiotherapists and the society.
With spinal stabilization exercises, the functional level and muscle architecture of individuals with chronic neck pain can be associated with architectural changes in the spinal muscles.
As a result of the 2020 years' pandemic, it is not known whether remote exercise and face-to-face exercises will have different effects on clinical variables, functional activities, muscle architecture, together with difficulties in accessing clinics.
The aim of the study is to investigate the effects of remote spinal stabilization exercises on functional level and muscle architecture on individuals with chronic neck pain.
Study Overview
Study Type
Interventional
Enrollment (Actual)
31
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 Contact
- Name: Dilara Onan, MSc
- Phone Number: +905358642234
- Email: dilaraonan@gmail.com
Study Locations
-
-
Altindag
-
Ankara, Altindag, Turkey, 06000
- Hacettepe University
-
-
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
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having neck pain for at least 3 months,
- Between the ages of 18-55,
- Being literate,
- Individuals who are capable of understanding exercises (Montreal Cognitive Assessment Scale (MOCA) total score> 21) will be included in the study.
Exclusion Criteria:
- Cervical radiculopathy, thoracic outlet syndrome,
- Malignant condition,
- Having systemic diseases such as neurological, psychological, cardiovascular and loss of function due to these diseases,
- A history of surgery in the spine and upper extremity, including the cervical region, in the last 1 year period,
- Fracture in the spine and upper extremity, including the cervical region, with a history of inflammation,
- Acute infection,
- Continuing another rehabilitation program,
- Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Remotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises
|
Spinal stabilization exercises
|
Other: Control Group
Face to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises
|
Spinal stabilization exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Muscle Thickness with Ultrasonography
Time Frame: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline Muscle Thickness at 8 weeks
|
Ultrasonography is used to evaluate the architectural properties of the muscle (such as thickness) in chronic painful musculoskeletal problems such as neck-back pain.
Muscle architecture measurements with ultrasound will be carried out before and after the exercise program by the specialist radiology doctor who is blind to the results of the study using 3.5-10 MHz convex and linear probes (Soundcam Mobile Ultrasound Device).
Within the scope of our study, the muscle thickness of the spinal muscles will be evaluated in the resting position.
|
15 minutes, through study completion, an average of 8 weeks, Change from Baseline Muscle Thickness at 8 weeks
|
Evaluation of Functional Capacity Level with Functional Capacity Assessment Test
Time Frame: 20 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
|
Functional capacity assessment evaluates the effectiveness (time to completion, weight it can handle) of each activity that includes different activities for neck pain.
The test includes the activities of "repetitive reaching out, lifting objects overhead, working overhead".
The validity and reliability of the Functional Capacity Assessment Test in individuals with chronic neck pain has been shown.
The time individuals can complete the tests will be recorded.
|
20 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
|
Evaluation of Functional Capacity Level with Back Performance Scale
Time Frame: 10 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
|
The back performance test (Back Performance Scale) is a test that evaluates the effectiveness of each activity that includes 5 different activities (socks test, gathering test, righting test, fingertip-floor test, carrying test).
The Back Performance Scale test is scored between 0-15 points.
An increase in score indicates a poor result.
|
10 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
|
Evaluation of the Functional Cross Sectional Area with Ultrasonography
Time Frame: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline the FCSA at 8 weeks
|
Ultrasonography is used to evaluate the architectural properties of the muscle (such as he Functional Cross Sectional Area (FCSA)) in chronic painful musculoskeletal problems such as neck-back pain.
Muscle architecture measurements with ultrasound will be carried out before and after the exercise program by the specialist radiology doctor who is blind to the results of the study using 3.5-10 MHz convex and linear probes (Soundcam Mobile Ultrasound Device).
Within the scope of our study, the muscle FCSA of the spinal muscles will be evaluated in the resting position.
|
15 minutes, through study completion, an average of 8 weeks, Change from Baseline the FCSA at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of quality of life
Time Frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline quality of life at 8 weeks
|
Quality of life Assessment: SF-36 SF-36 is a scale consisting of 36 questions that evaluates the health status of the person with 8 sub-items (physical function, role limitations, social function, mental health, vitality, pain, general health).
Scoring between 0-100 is made separately for each sub-item.
It indicates good health as the score approaches 100.
The validity and reliability study, Koçyiğit et al.
Made by.
|
5 minutes, through study completion, an average of 8 weeks, Change from Baseline quality of life at 8 weeks
|
Evaluation of pain severity
Time Frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline pain severity at 8 weeks
|
Pain Assessment: Visual Analogue Scale (VAS) VAS indicates the level of pain that the person is experiencing at the moment, marked with a vertical line on a plane.
The pain felt by the person is marked as "0: I feel no pain", "10: I feel very severe pain".
Scoring is based on measuring the participant's vertical marking for pain on the plane with a ruler.
The validity and reliability study of the scale was conducted by Price et al.
|
5 minutes, through study completion, an average of 8 weeks, Change from Baseline pain severity at 8 weeks
|
Evaluation of disability
Time Frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline disability at 8 weeks
|
Disability Assessment: Neck Disability Questionnaire (NDI) Vernon et al. developed by.
The Turkish version study was conducted by Aslan et al.
Made by.
The NDI includes a total of 10 questions such as pain, personal care, concentration, working, driving, sleeping.
Each question is scored between 0-5 points.
0 points means no restrictions, 50 points means complete apology.
0-4 points are evaluated as no disability, 5-14 points as mild disability, 14-24 points as moderate disability, 25-34 serious disability and 35 and above as complete disability.
|
5 minutes, through study completion, an average of 8 weeks, Change from Baseline disability at 8 weeks
|
Evaluation of neck awareness
Time Frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline neck awareness at 8 weeks
|
Awareness Assessment: Fremantle Neck Awareness Questionnaire (FreNAQ) Likert type that evaluates the altered perception specific to the individual (0 = Never / I never feel like this, 1 = I rarely feel this way, 2 = Sometimes, or sometimes I feel this way, 3 = I often feel this way, 4 = I always or often feel this way) it is a survey.
The questionnaire asks 9 questions to individuals such as how they perceive their neck according to their body, how they perceive their body position.
The Fremantle Back Awareness Questionnaire, which is the original version of the questionnaire, was conducted by Wand et al.
The Turkish validity and reliability of the neck version was developed by Onan et al.
|
5 minutes, through study completion, an average of 8 weeks, Change from Baseline neck awareness at 8 weeks
|
Evaluation of Exercise Adherence Assessment: Exercise Adherence Rating Scale (EARS) (EUAS)
Time Frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline Exercise Adaptation Assessment at 8 weeks
|
It will be evaluated using the Exercise Adherence Rating Scale (EARS), which evaluates exercise compliance.
The first 2 parts of the scale consist of 6 questions and the third part consists of 10 questions.
The first part is not included in the scoring and the maximum score to be obtained from two parts is 64.
An increase in score indicates an increased adaptation to exercise.
The Turkish validity and reliability study of the scale was conducted in 2019 by Korkmaz et al.
|
5 minutes, through study completion, an average of 8 weeks, Change from Baseline Exercise Adaptation Assessment at 8 weeks
|
Evaluation of Difficulty of Functional Activities and Exercise Program Satisfaction with Visual Analog Scale
Time Frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline Difficulty of Functional Activities and Exercise Program Satisfaction at 8 weeks
|
The Visual Analog Scale (VAS) is used in measurement by digitizing the values that cannot be measured numerically.
It is a line measurement, often on a 10 cm long horizontal or vertical line, where the person indicates his condition.
Pain is used in the literature to evaluate satisfaction.
In the satisfaction evaluation, it is evaluated as "0: there was no decrease in complaints, I am not satisfied, 10: complaints completely disappeared, I am very satisfied".
In the study, the functional activity difficulty will be evaluated as "0: Being unable to do the activity, 10: Being able to do the activity at the level before the neck pain started".
|
5 minutes, through study completion, an average of 8 weeks, Change from Baseline Difficulty of Functional Activities and Exercise Program Satisfaction at 8 weeks
|
Evaluation of kinesiophobia
Time Frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline kinesiophobia at 8 weeks
|
Kinesophobia Assessment: Tampa Kinesophobia Scale (TCS) It is a 17-question scale that evaluates injury avoidance and fear of movement, and Kori et al. developed by.
The Turkish version is from Tunca-Yılmaz et al.
Made by.
Its scoring is scored with "1 = Strongly disagree, 4 = Strongly agree".
The score is calculated by reversing items 4, 8, 12 and 16.
The total score is between 17 and 68.
It is understood that the higher the score, the higher the kinesiophobia.
A total score of more than 37 is considered to be a high degree of kinesophobia.
|
5 minutes, through study completion, an average of 8 weeks, Change from Baseline kinesiophobia at 8 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)
January 25, 2021
Primary Completion (Actual)
September 29, 2022
Study Completion (Actual)
September 29, 2022
Study Registration Dates
First Submitted
December 22, 2020
First Submitted That Met QC Criteria
December 30, 2020
First Posted (Actual)
December 31, 2020
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 28, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-20111
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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