Cervical Disc HerniationNCT05121467
Muscular Endurance And Its Association With Neck Pain, Disability, Neck Awareness, And Kinesiophobia
An observational study of Cervical Disc Herniation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the relationship of muscular endurance of the trunk, upper extremities, and scapular region as well as cervical region, with pain, neck awareness, and kinesiophobia in patients with cervical disc herniation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Disc Herniation
- What is being tested?
- Pain Assessment, Assessment of Muscular Endurance and Assessment of Neck Awareness
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 Jul 2020
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was carried out by patients who were diagnosed with cervical disc herniation and directed to Hacettepe University, Faculty of Physical Medicine and Rehabilitation for physical therapy consultation. The patients who met the inclusion criteria were given detailed information about the study, and signed a consent form.
Who may be able to join
- Having a diagnosis of cervical disc herniation confirmed by MR radiography, direct radiography, and clinical and physical examination
- Having neck pain at rest for 3 months or more with a severity of 2 or above according to the Visual Analogue Scale (VAS)
- Having a score of 5 or more from the NDI
- Being able to comply with the instructions of the physiotherapist
Who cannot join
- Patients with spinal tumors/deformities/congenital malformations
- Who underwent cervical or upper extremity surgery in the previous 6 months were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscular Endurance And Its Association With Neck Pain, Disability, Neck Awareness, And Kinesiophobia In Patients With Cervical Disc Herniation
The aim of this study was to investigate the relationship of muscular endurance of the trunk, upper extremities, and scapular region as well as cervical region, with pain, neck awareness, and kinesiophobia in patients with cervical disc herniation. Thirty-six patients between 18-65 years with a diagnosis of cervical disc herniation and having neck pain of 2 and above at rest according to the Visual Analogue Scale (VAS) were included in the study. After the evaluation of musculoskeletal system, endurance tests were performed for 9 muscles/muscle groups in the cervical and scapular regions, upper limb, and trunk. Pain severity was measured by VAS and Neck Disability Index (NDI), neck awareness with Fremantle Neck Awareness Questionnaire (FreNAQ), and fear of movement with Tampa Kinesiophobia Scale (TKS).
Read the detailed description
Cervical disc herniation occurs as a result of a sudden trauma or chemical/mechanical degenerative changes in the cervical spine, and is more common in women. The most common age range for disc herniation is 51-60 years with the increase in prevalence with age in both genders, and the most affected disc level is C6-C7. The clinical presentation such as weakness in cervical musculature, decreased endurance, loss of motor control and postural stabilization, changes in reflexes, loss of sensation, and movement limitations varies based on the location of the disc. The pain caused by any damage or compression in the cervical spinal nerve root is seen along the affected nerve dermatome as well as the head, neck, scapula, shoulder, and upper extremity, and accompanied by spasm in the cervical muscles.
Cervical muscles have a large number of sensory receptors responsible for vestibular, visual, and postural control by the deep suboccipital muscles with dense muscle spindles. They are responsible for the stabilization of the head, neck, and the thoracic region against involuntary perturbation by maintaining the continuity of the posture; they ensure the mobility of neck and upper limbs, and contribute neck awareness and postural reflexes. Intense proprioceptive receptors of deep cervical muscles support the motor control of the trunk muscles, mutually trunk muscles contribute to stabilization of the head and neck; and through the thoracolumbar fascia they work in coordination with scapular muscles. It has been known that any involvement of cervical, trunk, and scapular region muscles, as a whole, contribute to the etiology of the neck pain in patients due to their strong anatomical relations. In addition, the contribution of the upper extremity muscles in the stabilization of the cervical spine and the triggering of neck pain during upper extremity movements also reveal the importance of the motor control of upper extremity muscles in these patients.
Endurance of the cervical muscles has been known to have more responsibility on the spinal stabilization than strength in patients with chronic neck pain, causing an increase in pain with the decrease in endurance. In cervical disc herniation, the pathology in the cervical region causing the malalignment of the spine not only deteriorate the strength and endurance of the neck muscles, but it also affects other muscles around the spine. Further, proprioceptive receptors in the cervical muscles lose the ability to detect changes in muscle tension due to the reduced endurance, which in turn affect neck awareness. On the other hand, since chronic pain is closely related to cognitive and behavioral factors, pain worsens as a result of activity avoidance according to the fear-avoidance model, hence the kinesiophobia also increases by the decrease in cervical muscle endurance in chronic neck pain.
Recent studies revealed the connection between the endurance of neck muscles and pain, neck awareness, and fear of movement in patients with cervical disc herniation in literature. However, the evidence related to the relation between scapular, upper extremities, and trunk muscles' endurance and neck pain, neck awareness, and fear of movement has still been lacking. Therefore, the aim of the present study was to investigate the association between the endurance of these muscles and neck pain, neck awareness, and kinesiophobia in patients with cervical disc herniation.
- Conditions
- Cervical Disc Herniation
- Being tested
- Pain Assessment, Assessment of Muscular Endurance, Assessment of Neck Awareness, Assessment of Fear of Movement
- Keywords
- Degenerative Disc Disease, Cervical Spine, Neck Pain, Muscles
- Medical subject headings
- Intervertebral Disc Degeneration, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain AssessmentOther
Visual Analogue Scale (VAS) were included in the study
Assessment of Muscular EnduranceOther
The endurance of the 9 muscles/muscle groups including cervical flexor, extensor, deep flexor muscles, trunk flexor, extensor, lateral flexor, and stabilizer muscles, upper extremity, and scapular muscles (mm. serratus anterior and trapezius) were evaluated based on the assessment instructions given in the studies of Edmonston et al., Grimmer et al., Evans et al., Reece et al., ACSM guideline
Assessment of Neck AwarenessOther
The Turkish version of the Fremantle Neck Awareness Questionnaire (FreNAQ) which was developed by Wand et al. to assess neck awareness in patients with chronic neck pain was used in this study
Assessment of Fear of MovementOther
The fear of movement was assessed by the Turkish version of the Tampa Scale of Kinesiophobia which originally developed by Kori et al.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cervical Disc Herniation | Endurance tests were performed for 9 muscles/muscle groups in the cervical and scapular regions, upper limb, and trunk Visual Analogue Scale (VAS) and Neck Disability Index (NDI) Fremantle Neck Awareness Questionnaire (FreNAQ) Tampa Scale of Kinesiophobia (TSK) Receives: Other: Pain Assessment; Other: Assessment of Muscular Endurance; Other: Assessment of Neck Awareness; Other: Assessment of Fear of Movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Neck Flexor Muscular Endurance
The endurance of the neck flexor muscles was evaluated by elevating the head of the patient 6 cm in the supine hook position. With the removal of the head support, the maximum time spent in this position was recorded in seconds. The test was ceased when a 5-degree deviation seen in the goniometer which followed the vertical angle of the mandible.
Measured: two weeks
Assessment of Neck Extensor Muscular Endurance
Neck extensor muscle endurance was evaluated in prone position hanging the head and neck from the bed and placing the arms of the patients on side of the body. A 2 kg-weight (sandbag) was placed behind the head with a Velcro corresponding to the C6 level. The maximum time spent holding the head in neutral position was recorded in seconds.
Measured: two weeks
Assessment of Cervical Deep Flexor Muscular Endurance
Cervical deep flexor muscle endurance was evaluated in the supine hook position by asking the patients to put their hands on their abdomen, look at the chest level by pulling their chin inward and raising their head 2.5 cm from the bed. The maximum time spent to hold their head in this position was recorded.
Measured: two weeks
Assessment of Trunk Flexor Muscular Endurance
In order to evaluate the trunk flexor muscle endurance, the patients were asked to hold their hands on the opposite shoulders in the supine hook position. Then, they were asked to lift up the upper body until the lower end of the scapula lifted off the ground, and the maximum time spent to keep the position was recorded in seconds.
Measured: two weeks
Assessment of Trunk Extensor Muscular Endurance
Endurance of the trunk extensor muscles was evaluated in prone position hanging the upper body from the bed from the level of spina iliaca anterior superior. The lower limb was fixed by the evaluator. The participants were asked to bring both hands together on their neck and lift their body parallel to the ground. The maximum time spent to hold the position was noted in seconds.
Measured: two weeks
Assessment of Trunk Lateral Flexor Muscular Endurance
Endurance of the trunk lateral flexor muscles was assessed in a side-lying position and participants were asked to pull their knees gently on their abdomen. The upper leg was placed in front of the other foot. The body weight was carried on the forearm and feet, and the upper hand was placed on the opposite shoulder. Then, the patients were asked to elevate the hip until the pelvis and trunk reached a horizontal position. Measurements were made for each side, and the maximum time spent to maintain the position was recorded in seconds.
Measured: two weeks
Assessment of Trunk Stabilizer Muscular Endurance
The endurance of the trunk stabilizer muscles was evaluated in prone by the bridge test. The patients were initially asked to place in the prone position supported on the knee and forearms. Then, they were asked to stand on their forearms and toes by raising their knees and maintain this position. The time they held the position was noted in seconds.
Measured: two weeks
Assessment of Upper Extremity Muscular Endurance
Upper extremity muscular endurance was evaluated in a modified push-ups exercise position. Hands were placed shoulder-width apart on the ground, and the trunk was asked to be closer to the ground with elbow flexion in the prone position. Care was given to hold the body weight on the knees and hands. The number of repetitions for 30 seconds was noted.
Measured: two weeks
Assessment of M. serratus anterior and m. trapezius Muscular Endurance
- serratus anterior and m. trapezius muscles' endurance were evaluated via the scapular muscle endurance test. The patient was placed in standing position with shoulder and elbow flexed at 90°. A dynamometer (Feta 0202 1kg/10N) with a resistance of 1kg/10N was placed between hands by placing a 30 cm ruler between the elbows. The patients were asked to hold the dynamometer in the position that they would be most comfortable, and bring their shoulders to external rotation, and pull it with both hands. The time in which they were able to hold the position without dropping the ruler was noted in seconds.
Measured: two weeks
Assessment of Level of Pain
In order to evaluate the pain levels of the patients, Visual Analogue Scale (VAS), which was developed by Price et al. to evaluate the pain level of patients with chronic pain, was used.19 Patients were asked to rate their neck pain on the 10 cm horizontal line where "0" meant no pain, and "10" meant the most severe pain. The points that patients marked were measured with a ruler and noted as pain severity at resting, during activity, and night, separately.
Measured: two weeks
Assessment of Neck Awareness
The Turkish version of the Fremantle Neck Awareness Questionnaire (FreNAQ) which was developed by Wand et al. to assess neck awareness in patients with chronic neck pain was used in this study. The FreNAQ consists of 9 items related to neck pain, attention, and proprioceptive awareness. Each question is scored between 0 and 4 (0 = Never / I never feel this way, 1 = I rarely feel this way, 2 = I sometimes feel this way, 3 = I often feel this way, 4 = I often or always feel this way). The total score of the questionnaire is between 0 and 36. Higher scores indicate higher degrees of neck awareness
Measured: two weeks
Assessment of Fear of Movement
The fear of movement was assessed by the Turkish version of the Tampa Scale of Kinesiophobia which originally developed by Kori et al. The questionnaire which evaluates injury avoidance and fear of movement consists of 17 items, and each item is scored between 1 and 4 (1 = Strongly disagree, 4 = Strongly agree). The total score ranges from 17 to 68. Higher scores indicate a higher kinesiophobia level.
Measured: two weeks
Assessment of Disability
The NDI was developed as the neck version of the Oswestry Low Back Pain Disability Questionnaire to evaluate the disability caused by chronic neck pain. Each question is scored between 0 and 5 and the level of disability of the patients is classified according to the following scoring; 0-4 points, no disability; 5-14 points, mild disability; 14-24 points, moderate disability; 25-34 points, severe disability; and, 35-50 points, complete disability.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Jul 2019
- Primary completion1 Sep 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba DERE, Hacettepe University
- Investigators
- İpek A GÜRBÜZ, Ass. Prof., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121467
- Sponsor's protocol ID
- 200415001
- Status last verified
- Nov 2021
- First submitted
- 27 May 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hammer C, Heller J, Kepler C, editors. Epidemiology and pathophysiology of cervical disc herniation. Seminars in Spine Surgery; 2016: Elsevier.
Kumagai G, Wada K, Kudo H, Asari T, Chiba D, Ota S, Takeda O, Koyama K, Nakaji S, Ishibashi Y. Associations between cervical disc degeneration and muscle strength in a cross-sectional population-based study. PLoS One. 2019 Jan 25;14(1):e0210802. doi: 10.1371/journal.pone.0210802. eCollection 2019.
PubMed 30682082Sharrak S, Al Khalili YJS. Cervical disc herniation. 2020.
Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N Engl J Med. 2005 Jul 28;353(4):392-9. doi: 10.1056/NEJMcp043887. No abstract available.
PubMed 16049211Zabihhosseinian M, Holmes MW, Murphy B. Neck muscle fatigue alters upper limb proprioception. Exp Brain Res. 2015 May;233(5):1663-75. doi: 10.1007/s00221-015-4240-x. Epub 2015 Mar 13.
PubMed 25764200Kim JB, Yun CK, Lee MH. A comparison of the shoulder and trunk muscle activity according to the various resistance condition during push up plus in four point kneeling. J Phys Ther Sci. 2017 Jan;29(1):35-37. doi: 10.1589/jpts.29.35. Epub 2017 Jan 30.
PubMed 28210034Cromwell RL, Aadland-Monahan TK, Nelson AT, Stern-Sylvestre SM, Seder B. Sagittal plane analysis of head, neck, and trunk kinematics and electromyographic activity during locomotion. J Orthop Sports Phys Ther. 2001 May;31(5):255-62. doi: 10.2519/jospt.2001.31.5.255.
PubMed 11352192Gong W, Kim C, Lee YJJoPTS. Correlations between cervical lordosis, forward head posture, cervical ROM and the strength and endurance of the deep neck flexor muscles in college students. 2012;24(3):275-7.
Darnell MW. A proposed chronology of events for forward head posture. J Craniomandibular Pract. 1983 Sep-Nov;1(4):49-54. doi: 10.1080/07345410.1983.11677844. No abstract available.
PubMed 6586880Vaegter HB, Madsen AB, Handberg G, Graven-Nielsen T. Kinesiophobia is associated with pain intensity but not pain sensitivity before and after exercise: an explorative analysis. Physiotherapy. 2018 Jun;104(2):187-193. doi: 10.1016/j.physio.2017.10.001. Epub 2017 Oct 28.
PubMed 29290378Boersma K, Linton SJ. Psychological processes underlying the development of a chronic pain problem: a prospective study of the relationship between profiles of psychological variables in the fear-avoidance model and disability. Clin J Pain. 2006 Feb;22(2):160-6. doi: 10.1097/01.ajp.0000159582.37750.39.
PubMed 16428950Woodhouse A, Vasseljen O. Altered motor control patterns in whiplash and chronic neck pain. BMC Musculoskelet Disord. 2008 Jun 20;9:90. doi: 10.1186/1471-2474-9-90.
PubMed 18570647Falla DL. Neuromuscular control of the cervical spine in neck pain disorders. Fundamentals of Musculoskeletal Pain: IASP Press; 2008. p. 417-30.
Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 6226917Aslan E, Karaduman A, Yakut Y, Aras B, Simsek IE, Yagly N. The cultural adaptation, reliability and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976). 2008 May 15;33(11):E362-5. doi: 10.1097/BRS.0b013e31817144e1.
PubMed 18469684
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscular Endurance And Its Association With Neck Pain, Disability, Neck Awareness, And Kinesiophobia In Patients With Cervical Disc Herniation
- ClinicalTrials.gov ID
- NCT05121467
- Acronym / sponsor ID
- 200415001
- Conditions
- Cervical Disc Herniation
- Keywords
- Degenerative Disc Disease, Cervical Spine, Neck Pain, Muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 16 Nov 2021 (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.
The aim of this study was to investigate the relationship of muscular endurance of the trunk, upper extremities, and scapular region as well as cervical region, with pain, neck awareness, and kinesiophobia in patients with cervical disc herniation. Thirty-six patients between 18-65 years with a diagnosis of cervical disc herniation and having neck pain of 2 and above at rest according to the Visual Analogue Scale (VAS) were included in the study. After the evaluation of musculoskeletal system, endurance tests were performed for 9 muscles/muscle groups in the cervical and scapular regions, upper limb, and trunk. Pain severity was measured by VAS and Neck Disability Index (NDI), neck awareness with Fremantle Neck Awareness Questionnaire (FreNAQ), and fear of movement with Tampa Kinesiophobia Scale (TKS).
Detailed description
Cervical disc herniation occurs as a result of a sudden trauma or chemical/mechanical degenerative changes in the cervical spine, and is more common in women. The most common age range for disc herniation is 51-60 years with the increase in prevalence with age in both genders, and the most affected disc level is C6-C7. The clinical presentation such as weakness in cervical musculature, decreased endurance, loss of motor control and postural stabilization, changes in reflexes, loss of sensation, and movement limitations varies based on the location of the disc. The pain caused by any damage or compression in the cervical spinal nerve root is seen along the affected nerve dermatome as well as the head, neck, scapula, shoulder, and upper extremity, and accompanied by spasm in the cervical muscles.
Cervical muscles have a large number of sensory receptors responsible for vestibular, visual, and postural control by the deep suboccipital muscles with dense muscle spindles. They are responsible for the stabilization of the head, neck, and the thoracic region against involuntary perturbation by maintaining the continuity of the posture; they ensure the mobility of neck and upper limbs, and contribute neck awareness and postural reflexes. Intense proprioceptive receptors of deep cervical muscles support the motor control of the trunk muscles, mutually trunk muscles contribute to stabilization of the head and neck; and through the thoracolumbar fascia they work in coordination with scapular muscles. It has been known that any involvement of cervical, trunk, and scapular region muscles, as a whole, contribute to the etiology of the neck pain in patients due to their strong anatomical relations. In addition, the contribution of the upper extremity muscles in the stabilization of the cervical spine and the triggering of neck pain during upper extremity movements also reveal the importance of the motor control of upper extremity muscles in these patients.
Endurance of the cervical muscles has been known to have more responsibility on the spinal stabilization than strength in patients with chronic neck pain, causing an increase in pain with the decrease in endurance. In cervical disc herniation, the pathology in the cervical region causing the malalignment of the spine not only deteriorate the strength and endurance of the neck muscles, but it also affects other muscles around the spine. Further, proprioceptive receptors in the cervical muscles lose the ability to detect changes in muscle tension due to the reduced endurance, which in turn affect neck awareness. On the other hand, since chronic pain is closely related to cognitive and behavioral factors, pain worsens as a result of activity avoidance according to the fear-avoidance model, hence the kinesiophobia also increases by the decrease in cervical muscle endurance in chronic neck pain.
Recent studies revealed the connection between the endurance of neck muscles and pain, neck awareness, and fear of movement in patients with cervical disc herniation in literature. However, the evidence related to the relation between scapular, upper extremities, and trunk muscles' endurance and neck pain, neck awareness, and fear of movement has still been lacking. Therefore, the aim of the present study was to investigate the association between the endurance of these muscles and neck pain, neck awareness, and kinesiophobia in patients with cervical disc herniation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Cervical Disc Herniation | – | Other: Pain Assessment, Other: Assessment of Muscular Endurance, Other: Assessment of Neck Awareness, Other: Assessment of Fear of MovementEndurance tests were performed for 9 muscles/muscle groups in the cervical and scapular regions, upper limb, and trunk Visual Analogue Scale (VAS) and Neck Disability Index (NDI) Fremantle Neck Awareness Questionnaire (FreNAQ) Tampa Scale of Kinesiophobia (TSK) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was carried out by patients who were diagnosed with cervical disc herniation and directed to Hacettepe University, Faculty of Physical Medicine and Rehabilitation for physical therapy consultation. The patients who met the inclusion criteria were given detailed information about the study, and signed a consent form.
Key inclusion criteria (4 listed)
- Having a diagnosis of cervical disc herniation confirmed by MR radiography, direct radiography, and clinical and physical examination
- Having neck pain at rest for 3 months or more with a severity of 2 or above according to the Visual Analogue Scale (VAS)
- Having a score of 5 or more from the NDI
- Being able to comply with the instructions of the physiotherapist
Key exclusion criteria (2 listed)
- Patients with spinal tumors/deformities/congenital malformations
- Who underwent cervical or upper extremity surgery in the previous 6 months were excluded from the study.
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 |
|---|---|---|
| Pain AssessmentVisual Analogue Scale (VAS) were included in the study | Other | Patients with Cervical Disc Herniation |
| Assessment of Muscular EnduranceThe endurance of the 9 muscles/muscle groups including cervical flexor, extensor, deep flexor muscles, trunk flexor, extensor, lateral flexor, and stabilizer muscles, upper extremity, and scapular muscles (mm. serratus anterior and trapezius) were evaluated based on the assessment instructions given in the studies of Edmonston et al., Grimmer et al., Evans et al., Reece et al., ACSM guideline | Other | Patients with Cervical Disc Herniation |
| Assessment of Neck AwarenessThe Turkish version of the Fremantle Neck Awareness Questionnaire (FreNAQ) which was developed by Wand et al. to assess neck awareness in patients with chronic neck pain was used in this study | Other | Patients with Cervical Disc Herniation |
| Assessment of Fear of MovementThe fear of movement was assessed by the Turkish version of the Tampa Scale of Kinesiophobia which originally developed by Kori et al. | Other | Patients with Cervical Disc Herniation |
Primary outcome
Assessment of Neck Flexor Muscular Endurance
Time frame: two weeks
The endurance of the neck flexor muscles was evaluated by elevating the head of the patient 6 cm in the supine hook position. With the removal of the head support, the maximum time spent in this position was recorded in seconds. The test was ceased when a 5-degree deviation seen in the goniometer which followed the vertical angle of the mandible.
Assessment of Neck Extensor Muscular Endurance
Time frame: two weeks
Neck extensor muscle endurance was evaluated in prone position hanging the head and neck from the bed and placing the arms of the patients on side of the body. A 2 kg-weight (sandbag) was placed behind the head with a Velcro corresponding to the C6 level. The maximum time spent holding the head in neutral position was recorded in seconds.
Assessment of Cervical Deep Flexor Muscular Endurance
Time frame: two weeks
Cervical deep flexor muscle endurance was evaluated in the supine hook position by asking the patients to put their hands on their abdomen, look at the chest level by pulling their chin inward and raising their head 2.5 cm from the bed. The maximum time spent to hold their head in this position was recorded.
Assessment of Trunk Flexor Muscular Endurance
Time frame: two weeks
In order to evaluate the trunk flexor muscle endurance, the patients were asked to hold their hands on the opposite shoulders in the supine hook position. Then, they were asked to lift up the upper body until the lower end of the scapula lifted off the ground, and the maximum time spent to keep the position was recorded in seconds.
Assessment of Trunk Extensor Muscular Endurance
Time frame: two weeks
Endurance of the trunk extensor muscles was evaluated in prone position hanging the upper body from the bed from the level of spina iliaca anterior superior. The lower limb was fixed by the evaluator. The participants were asked to bring both hands together on their neck and lift their body parallel to the ground. The maximum time spent to hold the position was noted in seconds.
Assessment of Trunk Lateral Flexor Muscular Endurance
Time frame: two weeks
Endurance of the trunk lateral flexor muscles was assessed in a side-lying position and participants were asked to pull their knees gently on their abdomen. The upper leg was placed in front of the other foot. The body weight was carried on the forearm and feet, and the upper hand was placed on the opposite shoulder. Then, the patients were asked to elevate the hip until the pelvis and trunk reached a horizontal position. Measurements were made for each side, and the maximum time spent to maintain the position was recorded in seconds.
Assessment of Trunk Stabilizer Muscular Endurance
Time frame: two weeks
The endurance of the trunk stabilizer muscles was evaluated in prone by the bridge test. The patients were initially asked to place in the prone position supported on the knee and forearms. Then, they were asked to stand on their forearms and toes by raising their knees and maintain this position. The time they held the position was noted in seconds.
Assessment of Upper Extremity Muscular Endurance
Time frame: two weeks
Upper extremity muscular endurance was evaluated in a modified push-ups exercise position. Hands were placed shoulder-width apart on the ground, and the trunk was asked to be closer to the ground with elbow flexion in the prone position. Care was given to hold the body weight on the knees and hands. The number of repetitions for 30 seconds was noted.
Assessment of M. serratus anterior and m. trapezius Muscular Endurance
Time frame: two weeks
M. serratus anterior and m. trapezius muscles' endurance were evaluated via the scapular muscle endurance test. The patient was placed in standing position with shoulder and elbow flexed at 90°. A dynamometer (Feta 0202 1kg/10N) with a resistance of 1kg/10N was placed between hands by placing a 30 cm ruler between the elbows. The patients were asked to hold the dynamometer in the position that they would be most comfortable, and bring their shoulders to external rotation, and pull it with both hands. The time in which they were able to hold the position without dropping the ruler was noted in seconds.
Assessment of Level of Pain
Time frame: two weeks
In order to evaluate the pain levels of the patients, Visual Analogue Scale (VAS), which was developed by Price et al. to evaluate the pain level of patients with chronic pain, was used.19 Patients were asked to rate their neck pain on the 10 cm horizontal line where "0" meant no pain, and "10" meant the most severe pain. The points that patients marked were measured with a ruler and noted as pain severity at resting, during activity, and night, separately.
Assessment of Neck Awareness
Time frame: two weeks
The Turkish version of the Fremantle Neck Awareness Questionnaire (FreNAQ) which was developed by Wand et al. to assess neck awareness in patients with chronic neck pain was used in this study. The FreNAQ consists of 9 items related to neck pain, attention, and proprioceptive awareness. Each question is scored between 0 and 4 (0 = Never / I never feel this way, 1 = I rarely feel this way, 2 = I sometimes feel this way, 3 = I often feel this way, 4 = I often or always feel this way). The total score of the questionnaire is between 0 and 36. Higher scores indicate higher degrees of neck awareness
Assessment of Fear of Movement
Time frame: two weeks
The fear of movement was assessed by the Turkish version of the Tampa Scale of Kinesiophobia which originally developed by Kori et al. The questionnaire which evaluates injury avoidance and fear of movement consists of 17 items, and each item is scored between 1 and 4 (1 = Strongly disagree, 4 = Strongly agree). The total score ranges from 17 to 68. Higher scores indicate a higher kinesiophobia level.
Assessment of Disability
Time frame: two weeks
The NDI was developed as the neck version of the Oswestry Low Back Pain Disability Questionnaire to evaluate the disability caused by chronic neck pain. Each question is scored between 0 and 5 and the level of disability of the patients is classified according to the following scoring; 0-4 points, no disability; 5-14 points, mild disability; 14-24 points, moderate disability; 25-34 points, severe disability; and, 35-50 points, complete disability.
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 30 Nov 2021.
- BackgroundHammer C, Heller J, Kepler C, editors. Epidemiology and pathophysiology of cervical disc herniation. Seminars in Spine Surgery; 2016: Elsevier.
- Background: PubMed 30682082Kumagai G, Wada K, Kudo H, Asari T, Chiba D, Ota S, Takeda O, Koyama K, Nakaji S, Ishibashi Y. Associations between cervical disc degeneration and muscle strength in a cross-sectional population-based study. PLoS One. 2019 Jan 25;14(1):e0210802. doi: 10.1371/journal.pone.0210802. eCollection 2019.
- BackgroundSharrak S, Al Khalili YJS. Cervical disc herniation. 2020.
- Background: PubMed 16049211Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N Engl J Med. 2005 Jul 28;353(4):392-9. doi: 10.1056/NEJMcp043887. No abstract available.
- Background: PubMed 25764200Zabihhosseinian M, Holmes MW, Murphy B. Neck muscle fatigue alters upper limb proprioception. Exp Brain Res. 2015 May;233(5):1663-75. doi: 10.1007/s00221-015-4240-x. Epub 2015 Mar 13.
- Background: PubMed 28210034Kim JB, Yun CK, Lee MH. A comparison of the shoulder and trunk muscle activity according to the various resistance condition during push up plus in four point kneeling. J Phys Ther Sci. 2017 Jan;29(1):35-37. doi: 10.1589/jpts.29.35. Epub 2017 Jan 30.
- Background: PubMed 11352192Cromwell RL, Aadland-Monahan TK, Nelson AT, Stern-Sylvestre SM, Seder B. Sagittal plane analysis of head, neck, and trunk kinematics and electromyographic activity during locomotion. J Orthop Sports Phys Ther. 2001 May;31(5):255-62. doi: 10.2519/jospt.2001.31.5.255.
- BackgroundGong W, Kim C, Lee YJJoPTS. Correlations between cervical lordosis, forward head posture, cervical ROM and the strength and endurance of the deep neck flexor muscles in college students. 2012;24(3):275-7.
- Background: PubMed 6586880Darnell MW. A proposed chronology of events for forward head posture. J Craniomandibular Pract. 1983 Sep-Nov;1(4):49-54. doi: 10.1080/07345410.1983.11677844. No abstract available.
- Background: PubMed 29290378Vaegter HB, Madsen AB, Handberg G, Graven-Nielsen T. Kinesiophobia is associated with pain intensity but not pain sensitivity before and after exercise: an explorative analysis. Physiotherapy. 2018 Jun;104(2):187-193. doi: 10.1016/j.physio.2017.10.001. Epub 2017 Oct 28.
- Background: PubMed 16428950Boersma K, Linton SJ. Psychological processes underlying the development of a chronic pain problem: a prospective study of the relationship between profiles of psychological variables in the fear-avoidance model and disability. Clin J Pain. 2006 Feb;22(2):160-6. doi: 10.1097/01.ajp.0000159582.37750.39.
- Background: PubMed 18570647Woodhouse A, Vasseljen O. Altered motor control patterns in whiplash and chronic neck pain. BMC Musculoskelet Disord. 2008 Jun 20;9:90. doi: 10.1186/1471-2474-9-90.
- Individual participant dataSharing planned: Undecided
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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.
İpek A GÜRBÜZ, Ass. Prof. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Herniation, 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 2 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 30 Nov 2021. 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 Neck Flexor Muscular Endurance (time frame: two weeks). The study lists 13 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 NCT05121467, which also lists 48 linked publications.
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 30 Nov 2021.