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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06034223
Other study ID # IRB # 0220-23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2023
Est. completion date November 10, 2023

Study information

Verified date December 2023
Source Shifa Tameer-e-Millat University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of conventional physical therapy with and without cervical proprioceptive training using head-mounted laser system on cervical joint position sense error, pain, cervical range of motion and neck disability index. Proprioception disturbs in any function and structural impairments that is mechanical neck pain. Different studies has been done to find out the best therapy for pain management. Aim of the researcher is to give cost-effective, not so time-consuming, most effective physical therapy treatment. A literature gap exists on the effects of proprioceptive training combined with conventional physical therapy, no studies have directly compared the effect of proprioceptive training using head-mounted laser with and without conventional physical therapy. In our clinical setting, proprioceptive training for mechanical neck pain is not used as much as it should be. It would be a new thing to add and it can be cost-effective and better treatment for symptoms resolution


Description:

Mechanical neck pain (MNP) is a common condition, affecting 30% to 50% of the general population, and is most prevalent in middle age. It is responsible for reducing the quality of life and one of the leading causes of disability worldwide with annual prevalence of 48.5%. Mechanical neck pain is characterized by several structural and functional features. The causes of MNP include structural and functional impairment of cervical muscles, degenerative changes of cervical spine, arthritis, inflammation, and trauma, abnormal posture, and movements. Current studies have found that one of the main problems in patients with MNP is the impairment of cervical proprioception. decreased range of motion (ROM) and functional ability, greater muscle fatigability and a reduction in the strength and endurance capacity of the muscles. Despite neck disorders being so common in the population, little evidence supporting effective interventions has been identified. Conservative treatments used to help manage MNP are numerous and include usual medical care various forms of exercise, massage, and acupuncture. Medications, manual therapies, and exercise are the most widely used treatment modalities for MNP. 33% of individuals with neck pain sought care from physical therapy. Physical therapy improves pain, function and patient satisfaction in adults suffering from MNP, improves neck disability index. Physical therapy treatment includes cervical and thoracic spine mobilization/manipulation techniques active and passive exercise, ultrasound, transcutaneous electrical nerve stimulation, patient education. Spinal manipulative therapy (SMT), trigger point dry needling and trigger point manual therapy. Proprioception is the sense of perceiving self-movement, action of parts of the body and location. It is a term commonly used to describe the ascending information by the afferent receptors towards the central nervous system contributing to the neuromuscular control of movement and encompasses the sensation of joint movement (kinaesthesia) and joint position (joint position sense). Cervical spine has a very delicate proprioceptive system, which signals the position of the head relative to the trunk, coordinates the vestibular and visual systems and it plays a crucial role in controlling posture and balance and is of great importance for spatial orientation. The deficits of Proprioception of cervical spine have been associated with age, pain muscle fatigue, forward head posture, cervical spondylosis, reduced balance control and abnormal posture, decreased neck muscle strength and altered motor control in the cervical spine. In last two decades the interest in the assessment and treatment of proprioception of the cervical spine has increased exponentially. Cervical joint position sense (JPS) is a major component of proprioception and mainly reflects the ascending input (afferent) of cervical muscle, disc, capsule, and ligament receptors. Proprioception is evaluated using the Joint Position Sense Error (JPSE), which reflects a person's ability to accurately return his head to a predefined target after a cervical movement. Evidence to date suggests that the management of sensorimotor control disturbances due to chronic neck pain may need to address the primary causes and secondary effects of alterations in proprioceptive activity. A variety of treatments are available for cervical spine proprioception. It includes proprioception training, retraining of deep cervical flexor and extensor muscles, and etiological management of pain, strength training, cervical manipulation and acupuncture and many other conventional therapy protocols. Cervical proprioception training not only improves patient-perceived pain and disability but also has an effect on other aspects of neuromuscular function, specifically the coordination between the deep and superficial cervical flexors and balance.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date November 10, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 45 Years to 55 Years
Eligibility Inclusion Criteria: - Both genders - Age: 45 to 55 years - Mechanical neck pain more than 3 months (chronic stage) - Individuals having cervical radiculopathy (Spurling Test A and Spurling test B +ve) - Decreased Range of motion (Flexion 80 to 90*) (Extension 70*) (Lateral Flexion 20 TO 45*) (Rotation 90*) - Numeric Pain Rating Scale: 5 to 08 - Cervical spondylosis on Xray Exclusion Criteria: - Individuals having vascular pathology of neck. - Previous surgery related to cervical spine. - Individuals having structural deformity of spine (Adam's forward bend test) - Spinal Cord Injury /Cervical Myelopathy - Malignancy and tumor - Infection - Previous history of Cervical spine fractures

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Proprioceptive training using head mounted laser
Exercises include head relocation practice, i.e., relocating the head back to the natural head posture and to pre-determined positions in range with eyes open using feedback from a laser attached to their head. And then tracing the figure of eight with the help of laser.
Conventional Physical therpay
Conventional physical therapy for mechanical neck pain which includes cervical range of motion (flexion, extension, lateral rotation, and rotation), neck isometric exercises, stretching's (scalene, trapezius, SCM) and TENS with heating pad.

Locations

Country Name City State
Pakistan Shifa Tameer-e-Millat University Islamabad Islamabad Fedral

Sponsors (1)

Lead Sponsor Collaborator
Shifa Tameer-e-Millat University

Country where clinical trial is conducted

Pakistan, 

References & Publications (18)

Celenay ST, Akbayrak T, Kaya DO. A Comparison of the Effects of Stabilization Exercises Plus Manual Therapy to Those of Stabilization Exercises Alone in Patients With Nonspecific Mechanical Neck Pain: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Feb;46(2):44-55. doi: 10.2519/jospt.2016.5979. Epub 2016 Jan 11. — View Citation

de Vries J, Ischebeck BK, Voogt LP, van der Geest JN, Janssen M, Frens MA, Kleinrensink GJ. Joint position sense error in people with neck pain: A systematic review. Man Ther. 2015 Dec;20(6):736-44. doi: 10.1016/j.math.2015.04.015. Epub 2015 May 2. — View Citation

Ganesh GS, Mohanty P, Pattnaik M, Mishra C. Effectiveness of mobilization therapy and exercises in mechanical neck pain. Physiother Theory Pract. 2015 Feb;31(2):99-106. doi: 10.3109/09593985.2014.963904. Epub 2014 Sep 29. — View Citation

Gross AR, Kay T, Hondras M, Goldsmith C, Haines T, Peloso P, Kennedy C, Hoving J. Manual therapy for mechanical neck disorders: a systematic review. Man Ther. 2002 Aug;7(3):131-49. doi: 10.1054/math.2002.0465. — View Citation

Heikkila H, Johansson M, Wenngren BI. Effects of acupuncture, cervical manipulation and NSAID therapy on dizziness and impaired head repositioning of suspected cervical origin: a pilot study. Man Ther. 2000 Aug;5(3):151-7. doi: 10.1054/math.2000.0357. — View Citation

Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615. — View Citation

Leininger B, McDonough C, Evans R, Tosteson T, Tosteson AN, Bronfort G. Cost-effectiveness of spinal manipulative therapy, supervised exercise, and home exercise for older adults with chronic neck pain. Spine J. 2016 Nov;16(11):1292-1304. doi: 10.1016/j.spinee.2016.06.014. Epub 2016 Jun 23. — View Citation

Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30. Erratum In: J Orthop Sports Phys Ther. 2015 Feb;45(2):147. — View Citation

Peng B, Yang L, Li Y, Liu T, Liu Y. Cervical Proprioception Impairment in Neck Pain-Pathophysiology, Clinical Evaluation, and Management: A Narrative Review. Pain Ther. 2021 Jun;10(1):143-164. doi: 10.1007/s40122-020-00230-z. Epub 2021 Jan 12. — View Citation

Pinsault N, Vuillerme N. Degradation of cervical joint position sense following muscular fatigue in humans. Spine (Phila Pa 1976). 2010 Feb 1;35(3):294-7. doi: 10.1097/BRS.0b013e3181b0c889. — View Citation

Reddy RS, Meziat-Filho N, Ferreira AS, Tedla JS, Kandakurti PK, Kakaraparthi VN. Comparison of neck extensor muscle endurance and cervical proprioception between asymptomatic individuals and patients with chronic neck pain. J Bodyw Mov Ther. 2021 Apr;26:180-186. doi: 10.1016/j.jbmt.2020.12.040. Epub 2020 Dec 31. — View Citation

Reddy RS, Tedla JS, Dixit S, Abohashrh M. Cervical proprioception and its relationship with neck pain intensity in subjects with cervical spondylosis. BMC Musculoskelet Disord. 2019 Oct 15;20(1):447. doi: 10.1186/s12891-019-2846-z. — View Citation

Sarig-Bahat H. Evidence for exercise therapy in mechanical neck disorders. Man Ther. 2003 Feb;8(1):10-20. doi: 10.1054/math.2002.0480. — View Citation

Soysal M, Kara B, Arda MN. Assessment of physical activity in patients with chronic low back or neck pain. Turk Neurosurg. 2013;23(1):75-80. doi: 10.5137/1019-5149.JTN.6885-12.0. — View Citation

Strimpakos N, Sakellari V, Gioftsos G, Kapreli E, Oldham J. Cervical joint position sense: an intra- and inter-examiner reliability study. Gait Posture. 2006 Jan;23(1):22-31. doi: 10.1016/j.gaitpost.2004.11.019. — View Citation

Vincent K, Maigne JY, Fischhoff C, Lanlo O, Dagenais S. Systematic review of manual therapies for nonspecific neck pain. Joint Bone Spine. 2013 Oct;80(5):508-15. doi: 10.1016/j.jbspin.2012.10.006. Epub 2012 Nov 16. — View Citation

Vuillerme N, Pinsault N, Bouvier B. Cervical joint position sense is impaired in older adults. Aging Clin Exp Res. 2008 Aug;20(4):355-8. doi: 10.1007/BF03324868. — View Citation

Walker MJ, Boyles RE, Young BA, Strunce JB, Garber MB, Whitman JM, Deyle G, Wainner RS. The effectiveness of manual physical therapy and exercise for mechanical neck pain: a randomized clinical trial. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2371-8. doi: 10.1097/BRS.0b013e318183391e. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary cervical joint position sense error use to assess proprioception 4 weeks
Primary bubble inclinometer use to assess cervical range of motion 4 weeks
Primary numerical pain rating scale used for assessment of pain in which 0 means no pain and 10 means severe pain 4 weeks
Primary neck disability index used for pain related disability in which 0-4 means no disability 5-14 means mild disability 15-24 means moderate disability, 25-34 means severe disability and 35-50 means complete disability 4 weeks
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