Cervical Disc Herniation Clinical Trial
Official title:
Muscular Endurance And Its Association With Neck Pain, Disability, Neck Awareness, And Kinesiophobia In Patients With Cervical Disc Herniation
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 |
Verified date | November 2021 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Tugba | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Ariëns GA, Bongers PM, Douwes M, Miedema MC, Hoogendoorn WE, van der Wal G, Bouter LM, van Mechelen W. Are neck flexion, neck rotation, and sitting at work risk factors for neck pain? Results of a prospective cohort study. Occup Environ Med. 2001 Mar;58(3):200-7. — View Citation
Arslan T. Müzisyenlerde üst ekstremite fonksiyonlarinin degerlendirilmesi: Eastern Mediterranean University EMU; 2017.
Aslan E, Karaduman A, Yakut Y, Aras B, Simsek IE, Yaglý 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. — View Citation
Boersma 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. — View Citation
Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N Engl J Med. 2005 Jul 28;353(4):392-9. Review. — View Citation
Castelein B, Cools A, Bostyn E, Delemarre J, Lemahieu T, Cagnie B. Analysis of scapular muscle EMG activity in patients with idiopathic neck pain: a systematic review. J Electromyogr Kinesiol. 2015 Apr;25(2):371-86. doi: 10.1016/j.jelekin.2015.01.006. Epub 2015 Jan 31. Review. — View Citation
Cromwell 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. — View Citation
Darnell MW. A proposed chronology of events for forward head posture. J Craniomandibular Pract. 1983 Sep-Nov;1(4):49-54. — View Citation
Edmondston S, Björnsdóttir G, Pálsson T, Solgård H, Ussing K, Allison G. Endurance and fatigue characteristics of the neck flexor and extensor muscles during isometric tests in patients with postural neck pain. Man Ther. 2011 Aug;16(4):332-8. doi: 10.1016 — View Citation
Edmondston SJ, Wallumrød ME, Macléid F, Kvamme LS, Joebges S, Brabham GC. Reliability of isometric muscle endurance tests in subjects with postural neck pain. J Manipulative Physiol Ther. 2008 Jun;31(5):348-54. doi: 10.1016/j.jmpt.2008.04.010. — View Citation
Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. Epub 2006 Dec 1. — View Citation
Falla D, Bilenkij G, Jull G. Patients with chronic neck pain demonstrate altered patterns of muscle activation during performance of a functional upper limb task. Spine (Phila Pa 1976). 2004 Jul 1;29(13):1436-40. — View Citation
Falla D, Farina D. Neural and muscular factors associated with motor impairment in neck pain. Curr Rheumatol Rep. 2007 Dec;9(6):497-502. Review. — View Citation
Falla DL. Neuromuscular control of the cervical spine in neck pain disorders. Fundamentals of Musculoskeletal Pain: IASP Press; 2008. p. 417-30.
Ghamkhar L, Kahlaee AH. The effect of trunk muscle fatigue on postural control of upright stance: A systematic review. Gait Posture. 2019 Jul;72:167-174. doi: 10.1016/j.gaitpost.2019.06.010. Epub 2019 Jun 11. — View Citation
Gong 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.
Grimmer K. Measuring the endurance capacity of the cervical short flexor muscle group. Aust J Physiother. 1994;40(4):251-4. doi: 10.1016/S0004-9514(14)60461-X. — View Citation
Hammer C, Heller J, Kepler C, editors. Epidemiology and pathophysiology of cervical disc herniation. Seminars in Spine Surgery; 2016: Elsevier.
Hlavenka TM, Christner VFK, Gregory DE. Neck posture during lifting and its effect on trunk muscle activation and lumbar spine posture. Appl Ergon. 2017 Jul;62:28-33. doi: 10.1016/j.apergo.2017.02.006. Epub 2017 Feb 27. — View Citation
Im B, Kim Y, Chung Y, Hwang S. Effects of scapular stabilization exercise on neck posture and muscle activation in individuals with neck pain and forward head posture. J Phys Ther Sci. 2016 Mar;28(3):951-5. doi: 10.1589/jpts.28.951. Epub 2016 Mar 31. — View Citation
James WP. WHO recognition of the global obesity epidemic. Int J Obes (Lond). 2008 Dec;32 Suppl 7:S120-6. doi: 10.1038/ijo.2008.247. Review. — View Citation
Jull G, Falla D, Treleaven J, Sterling M, O'Leary S. A therapeutic exercise approach for cervical disorders. 2004
Kim 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. — View Citation
Kristjansson E, Treleaven J. Sensorimotor function and dizziness in neck pain: implications for assessment and management. J Orthop Sports Phys Ther. 2009 May;39(5):364-77. doi: 10.2519/jospt.2009.2834. Review. — View Citation
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. — View Citation
Lee H, Nicholson LL, Adams RD. Neck muscle endurance, self-report, and range of motion data from subjects with treated and untreated neck pain. J Manipulative Physiol Ther. 2005 Jan;28(1):25-32. — View Citation
Lin JJ, Lim HK, Soto-quijano DA, Hanten WP, Olson SL, Roddey TS, Sherwood AM. Altered patterns of muscle activation during performance of four functional tasks in patients with shoulder disorders: interpretation from voluntary response index. J Electromyogr Kinesiol. 2006 Oct;16(5):458-68. Epub 2005 Dec 1. — View Citation
Manske R, Reiman M. Functional performance testing for power and return to sports. Sports Health. 2013 May;5(3):244-50. doi: 10.1177/1941738113479925. — View Citation
Moseley GL. Impaired trunk muscle function in sub-acute neck pain: etiologic in the subsequent development of low back pain? Man Ther. 2004 Aug;9(3):157-63. — View Citation
Negrete RJ, Hanney WJ, Kolber MJ, Davies GJ, Ansley MK, McBride AB, Overstreet AL. Reliability, minimal detectable change, and normative values for tests of upper extremity function and power. J Strength Cond Res. 2010 Dec;24(12):3318-25. doi: 10.1519/JSC.0b013e3181e7259c. — View Citation
Neumanm DA. Kinesiology of the musculoskeletal system: foundations for physical rehabilitation: Mosby; 2002.
ONAN D. Kronik Boyun Agrili Hastalarda Boyun Farkindaliginin, Fremantle Boyun Farkindalik Anketi Ile Degerlendirilmesi: Türkçe Versiyon, Geçerlilik ve Güvenirlik Çalismasi. 2018.
Overholser BR, Sowinski KM. Biostatistics primer: part 2. Nutr Clin Pract. 2008 Feb;23(1):76-84. — View Citation
Peolsson A, Kjellman G. Neck muscle endurance in nonspecific patients with neck pain and in patients after anterior cervical decompression and fusion. J Manipulative Physiol Ther. 2007 Jun;30(5):343-50. — View Citation
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. — View Citation
Reece JD. Development of a prone bridge test as a measurement of abdominal stability in healthy adults. 2009.
Sahrmann S. Movement system impairment syndromes of the extremities, cervical and thoracic spines-e-book: Elsevier Health Sciences; 2010.
Santana JC. The Serape Effect: A Kinesiological Model for Core Training. Strength & Conditioning Journal. 2003;25(2).
Sharrak S, Al Khalili YJS. Cervical disc herniation. 2020.
Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008 Feb;13(1):2-11. Epub 2007 Aug 16. Review. — View Citation
Vaegter 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. — View Citation
Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15. Erratum in: J Manipulative Physiol Ther 1992 Jan;15(1):followi. — View Citation
Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18. — View Citation
Woby SR, Roach NK, Urmston M, Watson PJ. Psychometric properties of the TSK-11: a shortened version of the Tampa Scale for Kinesiophobia. Pain. 2005 Sep;117(1-2):137-44. — View Citation
Woodhouse 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. — View Citation
Yilmaz ÖT, Yakut Y, Uygur F, Ulug NJFR. Tampa Kinezyofobi Ölçegi'nin Türkçe versiyonu ve test-tekrar test güvenirligi. 2011;22(1):44-9.
Zabihhosseinian 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. — View Citation
* Note: There are 47 references in all — Click here to view all references
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06003907 -
Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical Disc Herniation
|
N/A | |
Not yet recruiting |
NCT06092138 -
Edge Computing Platform for Spine Health Risk Management Based on IoT Technology
|
N/A | |
Recruiting |
NCT06139263 -
The Effect of Vibration Therapy on Pain, Functionality and Proprioception in İndividuals With Cervical Disc Herniation
|
N/A | |
Completed |
NCT04597112 -
Effect of Myofascial Release Technique In Patients With Unilateral Cervical Radiculopathy
|
N/A | |
Recruiting |
NCT05638074 -
Does the Presence of Cervical Facet Tropism Affect the Response to Interlaminar Epidural Steroid Injections?
|
||
Not yet recruiting |
NCT04627454 -
Dynamic Cervical Implant in Treatment of Cervical Disc Disease
|
N/A | |
Recruiting |
NCT04214535 -
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
|
N/A | |
Enrolling by invitation |
NCT05066711 -
NuVasive® ACP System Study
|
||
Recruiting |
NCT05701059 -
Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty
|
||
Completed |
NCT01052324 -
The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation
|
Phase 4 | |
Recruiting |
NCT05374850 -
Impact of Cervical Parameters to Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients With Cervical Disc Herniation
|
||
Not yet recruiting |
NCT05270486 -
Safety and Efficacy of Electromagnetic Navigation System Assisted Percutaneous Endoscopic Lumbar Decompression
|
||
Completed |
NCT01945554 -
The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
|
N/A | |
Recruiting |
NCT04623593 -
Cervical Arthroplasty Cost Effectiveness Study (CACES)
|
N/A | |
Completed |
NCT04044092 -
Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) in Cervical Disc Protrusion
|
N/A | |
Completed |
NCT05501184 -
SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
|
N/A | |
Active, not recruiting |
NCT04235478 -
Effect of the Cervical Interlaminar Epidural Steroid Injection on Quality of Life, Pain and Disability
|
N/A | |
Completed |
NCT06098365 -
The Effects of CSE and ISE on Pain, Strength, Flexibility, Disability and QoL in Patients With CDH
|
N/A | |
Completed |
NCT05474625 -
Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation
|
N/A | |
Recruiting |
NCT02875431 -
Multicentric Registry for the Detection of C5 Palsy After Anterior Cervical Discectomy and Fusion
|
N/A |