Neck PainNCT04691024
Remotely Spinal Stabilization Exercises in Individuals With Chronic Neck Pain
A study testing Exercise in people with Neck Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2021to 29 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Neck Pain
- Being tested
- Exercise
- Keywords
- neck pain, spinal stabilization exercises, tele-rehabilitation, muscle architecture, functional level
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Spinal stabilization exercises
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Remotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises Receives: Other: Exercise |
| Control Group | Other | Face to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline Muscle Thickness at 8 weeks
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.
Measured: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline the FCSA at 8 weeks
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.
Measured: 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
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.
Measured: 10 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
Secondary outcomes (7)
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.
Measured: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline pain severity at 8 weeks
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.
Measured: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline disability at 8 weeks
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.
Measured: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline neck awareness at 8 weeks
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.
Measured: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline quality of life at 8 weeks
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.
Measured: 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
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".
Measured: 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
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.
Measured: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline kinesiophobia at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start25 Jan 2021
- Primary completion29 Sep 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Onan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691024
- Sponsor's protocol ID
- KA-20111
- Status last verified
- Feb 2023
- First submitted
- 22 Dec 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Onan D, Ulger O, Martelletti P. Effects of spinal stabilization exercises delivered using telerehabilitation on outcomes in patients with chronic neck pain: a randomized controlled trial. Expert Rev Neurother. 2023 Mar;23(3):269-280. doi: 10.1080/14737175.2023.2192870. Epub 2023 Mar 22.
PubMed 36927237
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remotely Applied Spinal Stabilization Exercises on Functional Level and Muscle Architecture in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04691024
- Acronym / sponsor ID
- KA-20111
- Conditions
- Neck Pain
- Keywords
- neck pain, spinal stabilization exercises, tele-rehabilitation, muscle architecture, functional level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: ExerciseRemotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises |
| Control Group | Other | Other: ExerciseFace to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSpinal stabilization exercises | Other | Control Group, Treatment Group |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
Evaluation of pain severity
Time frame: 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
Evaluation of neck awareness
Time frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline neck awareness at 8 weeks
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
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
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
Evaluation of kinesiophobia
Time frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline kinesiophobia at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 36927237Onan D, Ulger O, Martelletti P. Effects of spinal stabilization exercises delivered using telerehabilitation on outcomes in patients with chronic neck pain: a randomized controlled trial. Expert Rev Neurother. 2023 Mar;23(3):269-280. doi: 10.1080/14737175.2023.2192870. Epub 2023 Mar 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Neck Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.