NCT05391997

Brief Summary

The study aims to explore whether the modified cervical and shoulder retraction exercise program restores cervical sagittal alignment and reduces neck pain in patients with non-specific neck pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

May 23, 2022

Conditions

Keywords

neck painretractiondisabilitycervical traction

Outcome Measures

Primary Outcomes (3)

  • NPRS for pain

    The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    6th week

  • NDI for disability

    The neck disability index (NDI) has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50

    6th week

  • Lateral cervical radiograph for Cobb's angle

    Radiography of a patient provides important spine/posture data, such as segmental and total angles of curvature and sagittal balance. Cobb's angle measurement taken by Lateral Cervical Radiograph.

    6th week

Study Arms (2)

Modified Cervical and Shoulder Retraction exercises

EXPERIMENTAL

Cervical extension traction protocol will be added as standard treatment. Then, patients either sit or stand in an upright position while pushing their chin backward and simultaneously raising their head within the pain-free range, then, in a seated or standing position, patients will maintain an upright posture and try to pull back their shoulders and extend their neck within the pain-free range.

Other: Modified Cervical and Shoulder Retraction exercises

Cervical Extension Traction exercises

ACTIVE COMPARATOR

Here, patients will receive Cervical Extension Traction exercises as standard treatment. Cervical extension traction includes a protocol in which traction will be applied within the extension range of the cervical region in full spine position.

Other: Cervical Extension Traction exercises

Interventions

11 patients will receive cervical traction and modified cervical and shoulder retraction exercises (10 to 12 repetitions). The total treatment session will be of 20-25 minutes with a total intervention period of 6 weeks with 3 sessions per week on alternative days.

Modified Cervical and Shoulder Retraction exercises

11 patients will receive cervical traction force for 10 seconds and extend the cervical spine. The total treatment session will be of 20-25 minutes with a total intervention period of 6 weeks with 3 sessions per week on alternative days

Cervical Extension Traction exercises

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Neck pain history
  • Patients with Lateral Cervical Radiograph
  • Patients who agreed for a follow up of 6 weeks

You may not qualify if:

  • Congenital abnormalities e.g. torticollis
  • Past surgical history of cervical spine
  • Positive VBI sign
  • Patients with inflammatory or rheumatic diseases
  • Already undergoing physiotherapy treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy department Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (12)

  • Sbardella S, La Russa C, Bernetti A, Mangone M, Guarnera A, Pezzi L, Paoloni M, Agostini F, Santilli V, Saggini R, Paolucci T. Muscle Energy Technique in the Rehabilitative Treatment for Acute and Chronic Non-Specific Neck Pain: A Systematic Review. Healthcare (Basel). 2021 Jun 17;9(6):746. doi: 10.3390/healthcare9060746.

    PMID: 34204590BACKGROUND
  • Paolucci T, Agostini F, Mangone M, Bernetti A, Cordiani B, Bellomo RG, Saggini R, Villani C. Sagittal spine alignment and postural balance in pre-puberty age: a multidisciplinary and multi-professional rehabilitative point of view. J Biol Regul Homeost Agents. 2021 Jan-Feb;35(1):367-372. doi: 10.23812/20-621-L. No abstract available.

    PMID: 33511839BACKGROUND
  • Lee MY, Jeon H, Choi JS, Park Y, Ryu JS. Efficacy of Modified Cervical and Shoulder Retraction Exercise in Patients With Loss of Cervical Lordosis and Neck Pain. Ann Rehabil Med. 2020 Jun;44(3):210-217. doi: 10.5535/arm.19117. Epub 2020 May 29.

    PMID: 32475094BACKGROUND
  • de Zoete RM, Armfield NR, McAuley JH, Chen K, Sterling M. Comparative effectiveness of physical exercise interventions for chronic non-specific neck pain: a systematic review with network meta-analysis of 40 randomised controlled trials. Br J Sports Med. 2020 Nov 2:bjsports-2020-102664. doi: 10.1136/bjsports-2020-102664. Online ahead of print.

    PMID: 33139256BACKGROUND
  • Multanen J, Hakkinen A, Kautiainen H, Ylinen J. Associations of neck muscle strength and cervical spine mobility with future neck pain and disability: a prospective 16-year study. BMC Musculoskelet Disord. 2021 Oct 29;22(1):911. doi: 10.1186/s12891-021-04807-3.

    PMID: 34715847BACKGROUND
  • Jahre H, Grotle M, Smedbraten K, Dunn KM, Oiestad BE. Risk factors for non-specific neck pain in young adults. A systematic review. BMC Musculoskelet Disord. 2020 Jun 9;21(1):366. doi: 10.1186/s12891-020-03379-y.

    PMID: 32517732BACKGROUND
  • Jun D, Johnston V, McPhail SM, O'Leary S. A Longitudinal Evaluation of Risk Factors and Interactions for the Development of Nonspecific Neck Pain in Office Workers in Two Cultures. Hum Factors. 2021 Jun;63(4):663-683. doi: 10.1177/0018720820904231. Epub 2020 Mar 2.

    PMID: 32119582BACKGROUND
  • Moustafa IM, Diab AA, Hegazy F, Harrison DE. Demonstration of central conduction time and neuroplastic changes after cervical lordosis rehabilitation in asymptomatic subjects: a randomized, placebo-controlled trial. Sci Rep. 2021 Jul 28;11(1):15379. doi: 10.1038/s41598-021-94548-z.

    PMID: 34321539BACKGROUND
  • Oakley PA, Ehsani NN, Moustafa IM, Harrison DE. Restoring cervical lordosis by cervical extension traction methods in the treatment of cervical spine disorders: a systematic review of controlled trials. J Phys Ther Sci. 2021 Oct;33(10):784-794. doi: 10.1589/jpts.33.784. Epub 2021 Oct 13.

    PMID: 34658525BACKGROUND
  • Moon H, Lee SK, Kim WM, Seo YG. Effects of exercise on cervical muscle strength and cross-sectional area in patients with thoracic hyperkyphosis and chronic cervical pain. Sci Rep. 2021 Feb 15;11(1):3827. doi: 10.1038/s41598-021-83344-4.

    PMID: 33589667BACKGROUND
  • Villanueva-Ruiz I, Falla D, Lascurain-Aguirrebena I. Effectiveness of Specific Neck Exercise for Nonspecific Neck Pain; Usefulness of Strategies for Patient Selection and Tailored Exercise-A Systematic Review With Meta-Analysis. Phys Ther. 2022 Feb 1;102(2):pzab259. doi: 10.1093/ptj/pzab259.

    PMID: 34935963BACKGROUND
  • Kashfi P, Karimi N, Peolsson A, Rahnama L. The effects of deep neck muscle-specific training versus general exercises on deep neck muscle thickness, pain and disability in patients with chronic non-specific neck pain: protocol for a randomized clinical trial (RCT). BMC Musculoskelet Disord. 2019 Nov 14;20(1):540. doi: 10.1186/s12891-019-2880-x.

    PMID: 31727085BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Salman Bashir, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

May 23, 2022

First Posted

May 26, 2022

Study Start

June 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations