NCT05261698

Brief Summary

The main aim of this study is to determine the effects of routine physical therapy with and without home-based exercise manual on pain and disability in patients of postural neck pain. To exceptional time, the effects and outcomes of home-based exercise manual for the patients with postural neck pain have not yet been explored. Due to the current Covid-19 pandemic and social isolation, most of the individuals with office based occupations are performing their duties from their homes, which has some negative impact on their neck biomechanics and leads to the postural neck pain, this study will not only enlighten the beneficial effects of home-based exercise manual for the patients of postural neck pain, to reduce the risk of disability and improve their quality of life, but it will also be cost effective for them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

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

Study Start

First participant enrolled

July 9, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

February 19, 2022

Last Update Submit

May 7, 2022

Conditions

Keywords

Postural Neck Pain

Outcome Measures

Primary Outcomes (2)

  • Numerical Pain Rating Scale (NPRS)

    Pain will be measured by Numerical Pain Rating Scale (NPRS), in which patients are asked to circle the number between 0 and 10. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." The patient picks (verbal version) or draws a circle around.

    2 weeks

  • Neck Disability Index (NDI)

    The Neck Disability Index (NDI) is a self-report questionnaire which is used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. This questionnaire is used to gather the details about the intensity of neck pain among patients that has affected the capability to manage in daily routine. Every single section of this questionnaire is scored on a 0 to 5 rating scale, in which 0 means "no pain" whereas 5 means "worst imaginable pain".

    2 weeks

Study Arms (2)

Arms

ACTIVE COMPARATOR

Control group: in control group moist heating pads along with TENS shall be applied on neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed.

Other: Conventional PT

Assigned Interventions

EXPERIMENTAL

Experimental group: in the experimental group we will provide moist heating pads along with TENS on the neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed. Patients in the experimental group will also receive a home-based exercise manual.

Other: Home-based Exercise Manual

Interventions

in the experimental group we will provide moist heating pads along with TENS on the neck for 10 minutes and then neck isometrics and strengthening exercises shall be performed. Patients in the experimental group will also receive a home-based exercise manual.

Assigned Interventions

In this group patients will receive routine physical therapy including hot pack for 10 minutes, stretching, strengthening exercise and TENS at the end of each session.

Arms

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients with postural neck pain aged 18-60 years shall be included.
  • Patients experiencing postural neck pain at least once a week.
  • A symptom duration of greater than 3 months.
  • Postural neck pain that is aggravated by the sustained postural loading, and relieved by postural modification.
  • Patients who are able to read and write.

You may not qualify if:

  • Neck pain due to specific causes i.e. disc protrusion, radicular syndrome
  • Any accidental injury of spine
  • Inflammatory rheumatic disease
  • Congenital deformity of the spine
  • Spinal canal stenosis
  • Neoplasm
  • Females who are pregnant
  • Patients who had spinal surgery within the previous 12 months or any other invasive treatment of the spine within the previous 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Society for Rehabilitation of the Disabled

Lahore, Punjab Province, 54770, Pakistan

Location

Related Publications (14)

  • Gupta BD, Aggarwal S, Gupta B, Gupta M, Gupta N. Effect of Deep Cervical Flexor Training vs. Conventional Isometric Training on Forward Head Posture, Pain, Neck Disability Index In Dentists Suffering from Chronic Neck Pain. J Clin Diagn Res. 2013 Oct;7(10):2261-4. doi: 10.7860/JCDR/2013/6072.3487. Epub 2013 Oct 5.

    PMID: 24298492BACKGROUND
  • Argent R, Daly A, Caulfield B. Patient Involvement With Home-Based Exercise Programs: Can Connected Health Interventions Influence Adherence? JMIR Mhealth Uhealth. 2018 Mar 1;6(3):e47. doi: 10.2196/mhealth.8518.

    PMID: 29496655BACKGROUND
  • Cramer H, Lauche R, Hohmann C, Ludtke R, Haller H, Michalsen A, Langhorst J, Dobos G. Randomized-controlled trial comparing yoga and home-based exercise for chronic neck pain. Clin J Pain. 2013 Mar;29(3):216-23. doi: 10.1097/AJP.0b013e318251026c.

    PMID: 23249655BACKGROUND
  • Fakhry F, Spronk S, de Ridder M, den Hoed PT, Hunink MG. Long-term effects of structured home-based exercise program on functional capacity and quality of life in patients with intermittent claudication. Arch Phys Med Rehabil. 2011 Jul;92(7):1066-73. doi: 10.1016/j.apmr.2011.02.007.

    PMID: 21704786BACKGROUND
  • Baggetta R, D'Arrigo G, Torino C, ElHafeez SA, Manfredini F, Mallamaci F, Zoccali C, Tripepi G; EXCITE Working group. Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: a secondary analysis of the EXCITE trial. BMC Geriatr. 2018 Oct 20;18(1):248. doi: 10.1186/s12877-018-0938-5.

    PMID: 30342464BACKGROUND
  • Damasceno GM, Ferreira AS, Nogueira LAC, Reis FJJ, Andrade ICS, Meziat-Filho N. Text neck and neck pain in 18-21-year-old young adults. Eur Spine J. 2018 Jun;27(6):1249-1254. doi: 10.1007/s00586-017-5444-5. Epub 2018 Jan 6.

    PMID: 29306972BACKGROUND
  • Korakakis V, O'Sullivan K, O'Sullivan PB, Evagelinou V, Sotiralis Y, Sideris A, Sakellariou K, Karanasios S, Giakas G. Physiotherapist perceptions of optimal sitting and standing posture. Musculoskelet Sci Pract. 2019 Feb;39:24-31. doi: 10.1016/j.msksp.2018.11.004. Epub 2018 Nov 17.

    PMID: 30469124BACKGROUND
  • 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.

    PMID: 27134391BACKGROUND
  • Edmondston S, Bjornsdottir G, Palsson T, Solgard 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/j.math.2010.12.005. Epub 2011 Jan 20.

    PMID: 21256071BACKGROUND
  • Mani S, Sharma S, Singh DK. Concurrent validity and reliability of telerehabilitation-based physiotherapy assessment of cervical spine in adults with non-specific neck pain. J Telemed Telecare. 2021 Feb;27(2):88-97. doi: 10.1177/1357633X19861802. Epub 2019 Jul 4.

    PMID: 31272309BACKGROUND
  • Nasir MF, Jawed R, Baig NN, Younus M, Arshad A, Tahir A. A study to observe the effects of physiotherapy with and without manual therapy in the management postural neck pain: A randomized control trial. J Pak Med Assoc. 2021 Jan;71(1(A)):8-11. doi: 10.47391/JPMA.186.

    PMID: 33484509BACKGROUND
  • Wegner S, Jull G, O'Leary S, Johnston V. The effect of a scapular postural correction strategy on trapezius activity in patients with neck pain. Man Ther. 2010 Dec;15(6):562-6. doi: 10.1016/j.math.2010.06.006. Epub 2010 Jul 21.

    PMID: 20663706BACKGROUND
  • Pillastrini P, de Lima E Sa Resende F, Banchelli F, Burioli A, Di Ciaccio E, Guccione AA, Villafane JH, Vanti C. Effectiveness of Global Postural Re-education in Patients With Chronic Nonspecific Neck Pain: Randomized Controlled Trial. Phys Ther. 2016 Sep;96(9):1408-16. doi: 10.2522/ptj.20150501. Epub 2016 Mar 24.

    PMID: 27013576BACKGROUND
  • Richards KV, Beales DJ, Smith AJ, O'Sullivan PB, Straker LM. Neck Posture Clusters and Their Association With Biopsychosocial Factors and Neck Pain in Australian Adolescents. Phys Ther. 2016 Oct;96(10):1576-1587. doi: 10.2522/ptj.20150660. Epub 2016 May 12.

    PMID: 27174256BACKGROUND

Study Officials

  • Muhammad Adil, MPHIL-MSK*

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2022

First Posted

March 2, 2022

Study Start

July 9, 2021

Primary Completion

April 22, 2022

Study Completion

May 2, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations