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Mechanical Neck PainNCT06034223

Effect of Proprioceptive Training Using Head Mounted Laser in Chronic Mechanical Neck Pain

A study testing Proprioceptive training using head mounted laser and Conventional Physical therpay in people with Mechanical Neck Pain, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 45 to 55 years
Conditions the study is for
Mechanical Neck Pain
What is being tested?
Proprioceptive training using head mounted laser and Conventional Physical therpay
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
5 Sep 2023to 10 Nov 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 45 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Shifa Tameer-e-Millat University Islamabad

    Islamabad, Fedral, 44000

Other trials in Pakistan

About this study

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

Read the detailed 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.

Being tested
Proprioceptive training using head mounted laser, Conventional Physical therpay
Keywords
proprioception, joint position sense error, head mounted laser, cervical range of motion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proprioceptive training using head mounted laserOther

    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 therpayOther

    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.

Study groups in NCT06034223
Study groupRoleWhat they receive
Conventional Physical Therapy + Proprioceptive Training Using Head Mounted LaserExperimentalConventional physical therapy along with proprioceptive training, head relocation practice that is relocating the head back to the natural head posture and to pre determined postions in range with eyes open. Tracing figure of eight with eyes open. 3 days per week for 4 weeks, 15 repititions, 1 set.
Receives: Other: Proprioceptive training using head mounted laser; Other: Conventional Physical therpay
Conventional Physical Therapy onlyOtherConventional physical therapy, cervical range of motion (flexion, extension, lateral flexion and rotation), isometric exercises of neck muscles, stretching (scalene, trapezius, sternocleidomastoid), TENS, heating pad. 3 days per week for 4 weeks, 15 repitions, 1 set.
Receives: Other: Conventional Physical therpay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cervical joint position sense error

    use to assess proprioception

    Measured: 4 weeks

  2. bubble inclinometer

    use to assess cervical range of motion

    Measured: 4 weeks

  3. numerical pain rating scale

    used for assessment of pain in which 0 means no pain and 10 means severe pain

    Measured: 4 weeks

  4. 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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start5 Sep 2023
  3. Primary completion1 Nov 2023
  4. Study completion10 Nov 2023

Resources

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
Randomised
Intervention model
Parallel groups
Model description
the participants are divided into two groups, control group will recieve conventional physical therapy and experimental group will recieve proprioceptive training with conventional physcial therapy.
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06034223
Sponsor's protocol ID
IRB # 0220-23
Status last verified
Dec 2023
First submitted
5 Sep 2023
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26755405
  • 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.

    PubMed 33464539
  • 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.

    PubMed 25264016
  • 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.

    PubMed 12586557
  • 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.

    PubMed 28826164
  • 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.

    PubMed 23165183
  • 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.

    PubMed 12372310
  • 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.

    PubMed 18923311
  • 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.

    PubMed 27345747
  • 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.

    PubMed 25269764
  • 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.

    PubMed 16311191
  • 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.

    PubMed 31615495
  • 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.

    PubMed 33992242
  • 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.

    PubMed 18852550
  • 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.

    PubMed 25983238

Questions about this trial

What is this clinical trial studying?

A study testing Proprioceptive training using head mounted laser and Conventional Physical therpay in people with Mechanical Neck Pain, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.

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 7 inclusion and 7 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 8 Dec 2023. 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 Pakistan. 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?

cervical joint position sense error (time frame: 4 weeks). The study lists 4 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 NCT06034223, which also lists 18 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 8 Dec 2023.

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