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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05121467
Other study ID # 200415001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date July 1, 2020

Study information

Verified date November 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 1, 2020
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Having a diagnosis of cervical disc herniation confirmed by MR radiography, direct radiography, and clinical and physical examination 2. Having neck pain at rest for 3 months or more with a severity of 2 or above according to the Visual Analogue Scale (VAS) 3. Having a score of 5 or more from the NDI 4. Being able to comply with the instructions of the physiotherapist Exclusion Criteria: 1. Patients with spinal tumors/deformities/congenital malformations 2. Who underwent cervical or upper extremity surgery in the previous 6 months were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pain Assessment
Visual Analogue Scale (VAS) were included in the study
Assessment of Muscular Endurance
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 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
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.

Locations

Country Name City State
Turkey Tugba Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (47)

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* Note: There are 47 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. two weeks
Primary 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. two weeks
Primary 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. two weeks
Primary 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. two weeks
Primary 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. two weeks
Primary 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. two weeks
Primary 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. two weeks
Primary 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. two weeks
Primary Assessment of M. serratus anterior and m. trapezius Muscular Endurance 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. two weeks
Primary 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. two weeks
Primary 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 two weeks
Primary 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. two weeks
Primary 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. two weeks
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