NCT06034223

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

September 5, 2023

Last Update Submit

December 1, 2023

Conditions

Keywords

proprioceptionjoint position sense errorhead mounted lasercervical range of motion

Outcome Measures

Primary Outcomes (4)

  • cervical joint position sense error

    use to assess proprioception

    4 weeks

  • bubble inclinometer

    use to assess cervical range of motion

    4 weeks

  • numerical pain rating scale

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

    4 weeks

  • 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

Study Arms (2)

Conventional Physical Therapy + Proprioceptive Training Using Head Mounted Laser

EXPERIMENTAL

Conventional 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.

Other: Proprioceptive training using head mounted laserOther: Conventional Physical therpay

Conventional Physical Therapy only

OTHER

Conventional 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.

Other: Conventional Physical therpay

Interventions

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 Therapy + Proprioceptive Training Using Head Mounted Laser

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.

Conventional Physical Therapy + Proprioceptive Training Using Head Mounted LaserConventional Physical Therapy only

Eligibility Criteria

Age45 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa Tameer-e-Millat University Islamabad

Islamabad, Fedral, 44000, Pakistan

Location

Related 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.

    PMID: 26755405BACKGROUND
  • 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.

    PMID: 33464539BACKGROUND
  • 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.

    PMID: 25264016BACKGROUND
  • 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.

    PMID: 12586557BACKGROUND
  • 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.

    PMID: 28826164BACKGROUND
  • 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.

    PMID: 23165183BACKGROUND
  • 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.

    PMID: 12372310BACKGROUND
  • 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.

    PMID: 18923311BACKGROUND
  • 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.

    PMID: 27345747BACKGROUND
  • 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.

    PMID: 25269764BACKGROUND
  • 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.

    PMID: 16311191BACKGROUND
  • 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.

    PMID: 31615495BACKGROUND
  • 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.

    PMID: 33992242BACKGROUND
  • 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.

    PMID: 18852550BACKGROUND
  • 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.

    PMID: 25983238BACKGROUND
  • 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.

    PMID: 20075783BACKGROUND
  • 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.

    PMID: 11034885BACKGROUND
  • 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.

    PMID: 23344871BACKGROUND

Study Officials

  • Nida Waseem, MS-PT*

    Shifa Tameer-e-millet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
It is a single blinded study in which participants will be alocated in two groups using simple random sampling.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

September 5, 2023

Primary Completion

November 1, 2023

Study Completion

November 10, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations