Neck PainNCT06337916
The Effect of Cervical Stabilization Exercises on the Cervical Proprioception in Patients With Chronic Neck Pain
A study testing Cervical Stabilization Exercise and Cervical Standard Exercise Group in people with Neck Pain and Chronic Neck Pain, run by Şenay Özdolap at 1 site in Turkey (Türkiye).
Trial summary
Neck pain is one of the most common musculoskeletal complaints and its prevalence is between 10-22%. Approximately half of all individuals will experience a clinically important neck pain episode over the course of their lifetime. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain, Chronic Neck Pain
- What is being tested?
- Cervical Stabilization Exercise and Cervical Standard Exercise Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2022to 30 Jan 2023
- 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
- The patients age is between the ages of 18-55
- Being literate and with good cognitive function,
- Having neck pain longer than 3 months
- Not taking painkillers and nsaid in the last 1 week
Who cannot join
- Cervical extruded or sequestered disc herniation, diagnosis of myelopathy
- Having neck and shoulder surgery
- Diagnosis of major trauma, infection, malignancy, inflammatory disease or peripheral nerve compression, spinal congenital anatomical deformity
- Having severe cardiovascular disease, neurological or mental illness and inability to tolerate treatment
- Kyphoscoliosis
- Osteoporosis
Show all 13Show fewer
- Stage 3-4 osteoarthritis
- Diagnosis of diabetes mellitus, uncontrolled hypertension
- Having a diagnosis of fibromyalgia
- Spinal stenosis
- Pregnancy
- Receiving physical therapy in less than 3 months
- Obesity (BMI>30)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University
Zonguldak, 67100
About this study
Official title: The Effect of Cervical Stabilization Exercises on the Sense of Cervical Proprioception in Patients With Chronic Neck Pain
Neck pain is one of the most common musculoskeletal complaints and its prevalence is between 10-22%. Approximately half of all individuals will experience a clinically important neck pain episode over the course of their lifetime. Neck pain is categorized by duration as acute, subacute and chronic neck pain (acute, <6 weeks; subacute, ≤3 months; chronic, >3 months). Chronic neck pain is more common in women and its incidence increases with age. Cervical disc herniation, cervical spondylosis, cervical stenosis, myofascial pain syndrome, cervical instability, whiplash injury, Klippel feil syndrome, thoracic outlet syndrome, cervical sprain, cervical strain, tumors, rheumatic diseases, torticollis, inflammatory neck pain are the main causes.
Anterior tilt of the head is a common posture in neck pain. In this posture, the upper cervical vertebrae are extension, the lower cervical vertebrae are flexion and the cervical lordosis is decreased. With neck pain, inhibition occurs in the deep neck flexor (longus coli and capitis) and extensor (multifidus, rotator, semispinalis) muscles, increased fat infiltration, deterioration in type 1 and 2 fiber ratios, and muscle atrophy. The risk of micro and macro trauma increases and muscle support decreases. Thus, there is an increase in the activation response and fatigue of the neck superficial muscle group (trapeze, scalene, sternocleidomastoid muscles), and a decrease in neck joint movement and proprioception sense. As a result, it was determined that there are deficiencies in the sense of proprioception in patients with neck pain.
Read more
Studies have shown that many receptors related to the sense of position are on deep cervical flexor muscles such as Musculus Longus Capitis and Musculus Longus Colli. In cases where there are changes such as atrophy and fat infiltration in these muscles, there is a decrease in proprioceptive sensation.Conservative treatment is the first choice in the treatment of neck pain. The important components of this treatment are stretching, strengthening, posture, stabilization, proprioception, relaxation, joint movement exercises and aerobic exercises. The purpose of stabilization exercises, which have been used in the treatment of chronic neck pain recently; to support the vertebral column by activating the stabilizing muscles and to improve posture by increasing kinesthetic awareness.
This study will examine the relationship between the sense of cervical proprioception and cervical stabilization exercises in patients with chronic neck pain.
In this study, between 15 June 2022 and 30 January 2023; 72 volunteers, aged between 18-55 years, with neck pain for more than 3 months, with good cognitive function, who applied to the our Physical Medicine and Rehabilitation Clinic will be included. The patients will be randomized to two groups as cervical stabilization exercise group and conventional cervical exercise treatment group. The patients in group 1 will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks, and the patients in group 2 will perform cervical stabilization exercises for 6 weeks, 3 days a week, 1 session a day. conventional cervical exercises will be given. Patients of both groups will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.
Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.
Demographic information (address, telephone, age, occupation, height, weight, marital status, etc.) of the patients to be included in the study will be recorded and general musculoskeletal examinations will be performed. The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form-36 (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM).
- Conditions
- Neck Pain, Chronic Neck Pain
- Being tested
- Cervical Stabilization Exercise, Cervical Standard Exercise Group
- Keywords
- Chronic Neck Pain, Cervical Stabilization Exercises, Cervical Proprioception
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Stabilization ExerciseBehavioural
The cervical stabilization exercise group will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks. Patients will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.Demographic information of the patients to be included in the study will be recorded . The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM).
Cervical Standard Exercise GroupBehavioural
The patients in cervical standard exercise group will receive conventional cervical exercise for 6 weeks, 3 days a week, 1 session a day. Patients will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.Demographic information of the patients to be included in the study will be recorded . The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM).
| Study group | Role | What they receive |
|---|---|---|
| Cervical Stabilization Exercise Group | Active comparator | 1. The patients age is between the ages of 18-55
2. Being literate and with good cognitive function,
3. Having neck pain longer than 3 months
4. Not taking painkillers and nsaid in the last 1 week Receives: Behavioral: Cervical Stabilization Exercise |
| Cervical Standard Exercise Group | Active comparator | 1. The patients age is between the ages of 18-55
2. Being literate and with good cognitive function,
3. Having neck pain longer than 3 months
4. Not taking painkillers and nsaid in the last 1 week Receives: Behavioral: Cervical Standard Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of cervical joint position sense
Cervical joint position sense will be evaluated with the CROM (Cervical Range of Motion) Deluxe Device.
Measured: 6 weeks
Secondary outcomes (4)
assessment of cervical range of motion
Cervical range of motion will be evaluated with the CROM (Cervical Range of Motion) Deluxe Device.
Measured: 6 weeks
assessment of neck disability
The patients will be evaluate with the Neck Disability Index (NDI) for assessment of neck disability. The score ranges from 0 to 50. As the score increases, disability increases.
Measured: 6 weeks
assessment of pain
The patients will be evaluate with the Visual Analogue Scale (VAS) for assessment of pain. They are numbered from 1 to 10. As the score increases, pain intensity increases.
Measured: 6 weeks
assessment of life quality
The patients will be evaluate with the Short Form (SF-36) for life quality. The SF-36 consists of 36 items - that are grouped in 8 subscales or domains: Physical functioning (10 items); Role limitations due to physical health (4 items); Role limitations due to emotional problems (4 items); Energy/fatigue (4 items); Emotional well-being (5 items); Social functioning (2 items); Pain (2 items); General health (5 items). Scoring is between 0-100, higher scores indicate good health status.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start7 Oct 2022
- Primary completion25 Nov 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şenay Özdolap
- Sponsor type
- University, hospital or other
- Collaborators
- Zonguldak Bulent Ecevit University
- Responsible party
- Sponsor-investigator, Şenay Özdolap, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337916
- Sponsor's protocol ID
- 2021/16-01
- Status last verified
- Mar 2024
- First submitted
- 7 Nov 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cervical Stabilization Exercises on the Sense of Cervical Proprioception in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06337916
- Acronym / sponsor ID
- 2021/16-01
- Conditions
- Neck Pain, Chronic Neck Pain
- Keywords
- Chronic Neck Pain, Cervical Stabilization Exercises, Cervical Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Şenay ÖzdolapUniversity, hospital or other
- Collaborators
- Zonguldak Bulent Ecevit University
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 29 Mar 2024 (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 one of the most common musculoskeletal complaints and its prevalence is between 10-22%. Approximately half of all individuals will experience a clinically important neck pain episode over the course of their lifetime. Neck pain is categorized by duration as acute, subacute and chronic neck pain (acute, <6 weeks; subacute, ≤3 months; chronic, >3 months). Chronic neck pain is more common in women and its incidence increases with age. Cervical disc herniation, cervical spondylosis, cervical stenosis, myofascial pain syndrome, cervical instability, whiplash injury, Klippel feil syndrome, thoracic outlet syndrome, cervical sprain, cervical strain, tumors, rheumatic diseases, torticollis, inflammatory neck pain are the main causes.
Anterior tilt of the head is a common posture in neck pain. In this posture, the upper cervical vertebrae are extension, the lower cervical vertebrae are flexion and the cervical lordosis is decreased. With neck pain, inhibition occurs in the deep neck flexor (longus coli and capitis) and extensor (multifidus, rotator, semispinalis) muscles, increased fat infiltration, deterioration in type 1 and 2 fiber ratios, and muscle atrophy. The risk of micro and macro trauma increases and muscle support decreases. Thus, there is an increase in the activation response and fatigue of the neck superficial muscle group (trapeze, scalene, sternocleidomastoid muscles), and a decrease in neck joint movement and proprioception sense. As a result, it was determined that there are deficiencies in the sense of proprioception in patients with neck pain.
Studies have shown that many receptors related to the sense of position are on deep cervical flexor muscles such as Musculus Longus Capitis and Musculus Longus Colli. In cases where there are changes such as atrophy and fat infiltration in these muscles, there is a decrease in proprioceptive sensation.Conservative treatment is the first choice in the treatment of neck pain. The important components of this treatment are stretching, strengthening, posture, stabilization, proprioception, relaxation, joint movement exercises and aerobic exercises. The purpose of stabilization exercises, which have been used in the treatment of chronic neck pain recently; to support the vertebral column by activating the stabilizing muscles and to improve posture by increasing kinesthetic awareness.
This study will examine the relationship between the sense of cervical proprioception and cervical stabilization exercises in patients with chronic neck pain.
In this study, between 15 June 2022 and 30 January 2023; 72 volunteers, aged between 18-55 years, with neck pain for more than 3 months, with good cognitive function, who applied to the our Physical Medicine and Rehabilitation Clinic will be included. The patients will be randomized to two groups as cervical stabilization exercise group and conventional cervical exercise treatment group. The patients in group 1 will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks, and the patients in group 2 will perform cervical stabilization exercises for 6 weeks, 3 days a week, 1 session a day. conventional cervical exercises will be given. Patients of both groups will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.
Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.
Demographic information (address, telephone, age, occupation, height, weight, marital status, etc.) of the patients to be included in the study will be recorded and general musculoskeletal examinations will be performed. The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form-36 (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Stabilization Exercise Group | Active comparator | Behavioral: Cervical Stabilization Exercise1. The patients age is between the ages of 18-55 2. Being literate and with good cognitive function, 3. Having neck pain longer than 3 months 4. Not taking painkillers and nsaid in the last 1 week |
| Cervical Standard Exercise Group | Active comparator | Behavioral: Cervical Standard Exercise Group1. The patients age is between the ages of 18-55 2. Being literate and with good cognitive function, 3. Having neck pain longer than 3 months 4. Not taking painkillers and nsaid in the last 1 week |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patients age is between the ages of 18-55
- Being literate and with good cognitive function,
- Having neck pain longer than 3 months
- Not taking painkillers and nsaid in the last 1 week
Key exclusion criteria (13 listed)
- Cervical extruded or sequestered disc herniation, diagnosis of myelopathy
- Having neck and shoulder surgery
- Diagnosis of major trauma, infection, malignancy, inflammatory disease or peripheral nerve compression, spinal congenital anatomical deformity
- Having severe cardiovascular disease, neurological or mental illness and inability to tolerate treatment
- Kyphoscoliosis
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 |
|---|---|---|
| Cervical Stabilization ExerciseThe cervical stabilization exercise group will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks. Patients will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.Demographic information of the patients to be included in the study will be recorded . The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM). | Behavioural | Cervical Stabilization Exercise Group |
| Cervical Standard Exercise GroupThe patients in cervical standard exercise group will receive conventional cervical exercise for 6 weeks, 3 days a week, 1 session a day. Patients will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.Demographic information of the patients to be included in the study will be recorded . The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM). | Behavioural | Cervical Standard Exercise Group |
Primary outcome
assessment of cervical joint position sense
Time frame: 6 weeks
Cervical joint position sense will be evaluated with the CROM (Cervical Range of Motion) Deluxe Device.
4 secondary outcomes
assessment of cervical range of motion
Time frame: 6 weeks
assessment of neck disability
Time frame: 6 weeks
assessment of pain
Time frame: 6 weeks
assessment of life quality
Time frame: 6 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 2 Apr 2024.
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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 Cervical Stabilization Exercise and Cervical Standard Exercise Group in people with Neck Pain and Chronic Neck Pain, run by Şenay Özdolap 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 13 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 2 Apr 2024. 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?
assessment of cervical joint position sense (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.