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Completed

NCT Number: NCT04691024

Remotely Spinal Stabilization Exercises 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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Altindag, 06000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

Spinal stabilization exercises

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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. 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.

  6. 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".

  7. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Effects of Remotely Applied Spinal Stabilization Exercises on Functional Level and Muscle Architecture in Individuals With Chronic Neck Pain

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 31, 2020
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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