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Remotely Spinal Stabilization Exercises in Individuals With Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, spinal stabilization exercises, tele-rehabilitation, muscle architecture, functional level

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment Group

Control Group

Arm Description

Remotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises

Face to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises

Outcomes

Primary Outcome Measures

Evaluation of Muscle Thickness with Ultrasonography
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.
Evaluation of the Functional Cross Sectional Area with Ultrasonography
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.
Evaluation of Functional Capacity Level with Functional Capacity Assessment Test
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.
Evaluation of Functional Capacity Level with Back Performance Scale
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.

Secondary Outcome Measures

Evaluation of pain severity
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.
Evaluation of disability
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.
Evaluation of neck awareness
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.
Evaluation of quality of life
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.
Evaluation of Exercise Adherence Assessment: Exercise Adherence Rating Scale (EARS) (EUAS)
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.
Evaluation of Difficulty of Functional Activities and Exercise Program Satisfaction with Visual Analog Scale
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".
Evaluation of kinesiophobia
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.

Full Information

First Posted
December 22, 2020
Last Updated
February 28, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04691024
Brief Title
Remotely Spinal Stabilization Exercises in Individuals With Chronic Neck Pain
Official Title
Effects of Remotely Applied Spinal Stabilization Exercises on Functional Level and Muscle Architecture in Individuals With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, spinal stabilization exercises, tele-rehabilitation, muscle architecture, functional level

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Remotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises
Arm Title
Control Group
Arm Type
Other
Arm Description
Face to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Spinal stabilization exercises
Primary Outcome Measure Information:
Title
Evaluation of Muscle Thickness with Ultrasonography
Description
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.
Time Frame
15 minutes, through study completion, an average of 8 weeks, Change from Baseline Muscle Thickness at 8 weeks
Title
Evaluation of the Functional Cross Sectional Area with Ultrasonography
Description
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.
Time Frame
15 minutes, through study completion, an average of 8 weeks, Change from Baseline the FCSA at 8 weeks
Title
Evaluation of Functional Capacity Level with Functional Capacity Assessment Test
Description
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.
Time Frame
20 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
Title
Evaluation of Functional Capacity Level with Back Performance Scale
Description
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.
Time Frame
10 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
Secondary Outcome Measure Information:
Title
Evaluation of pain severity
Description
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.
Time Frame
5 minutes, through study completion, an average of 8 weeks, Change from Baseline pain severity at 8 weeks
Title
Evaluation of disability
Description
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.
Time Frame
5 minutes, through study completion, an average of 8 weeks, Change from Baseline disability at 8 weeks
Title
Evaluation of neck awareness
Description
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.
Time Frame
5 minutes, through study completion, an average of 8 weeks, Change from Baseline neck awareness at 8 weeks
Title
Evaluation of quality of life
Description
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.
Time Frame
5 minutes, through study completion, an average of 8 weeks, Change from Baseline quality of life at 8 weeks
Title
Evaluation of Exercise Adherence Assessment: Exercise Adherence Rating Scale (EARS) (EUAS)
Description
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.
Time Frame
5 minutes, through study completion, an average of 8 weeks, Change from Baseline Exercise Adaptation Assessment at 8 weeks
Title
Evaluation of Difficulty of Functional Activities and Exercise Program Satisfaction with Visual Analog Scale
Description
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".
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
Title
Evaluation of kinesiophobia
Description
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.
Time Frame
5 minutes, through study completion, an average of 8 weeks, Change from Baseline kinesiophobia at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Altindag
ZIP/Postal Code
06000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Remotely Spinal Stabilization Exercises in Individuals With Chronic Neck Pain

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