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Effects of Cervical Extension Traction With & Without Modified Cervical and Shoulder Retraction Exercises in Neck Pain

Primary Purpose

Neck Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Modified Cervical and Shoulder Retraction exercises
Cervical Extension Traction exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, retraction, disability, cervical traction

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Physiotherapy department Services Hospital Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Cervical and Shoulder Retraction exercises

Cervical Extension Traction exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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
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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
May 23, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05391997
Brief Title
Effects of Cervical Extension Traction With & Without Modified Cervical and Shoulder Retraction Exercises in Neck Pain
Official Title
Comparative Effects of Cervical Extension Traction Exercises With and Without Modified Cervical and Shoulder Retraction Exercises on Pain, Disability and Cobb's Angle in Patients With Non-specific Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Neck pain is a musculoskeletal system disorder that causes social and economic loss by reducing the quality of life (QOL) of the individual, and its prevalence varies from 16.7 to 75.1% in the adult population. Non-specific neck pain (NNP) is a symptom related to a postural or mechanical cause. NNP is also associated with loss of cervical curvature. In healthy spines, the axial load along the cervical spine is supported along the ventral column of the spine. However, in spines with the loss of lordosis, the load moves more anteriorly, which causes neck pain. Cervical exercise has been shown to be an effective treatment for neck pain and cervical alignment, but there is still a need for more clinical trials evaluating the effectiveness of the exercise approach. It seems reasonable to assume that naturally good neck muscle strength and range of motion are likely to be protective factors against neck pain. As per previous research, the effects of exercise therapy on non-specific neck pain have been examined but there is limited literature available for use of cervical and shoulder retraction exercises in patients with nonspecific neck pain. Most of the studies have been done with neck isometrics, manual mobilization, and deep cervical flexors training and there is less scope of practicing cervical extension traction in contrast with modified cervical and shoulder retraction exercises. Previous research is limited by no use of a control group in a modified retraction exercise regime. To fill this literature gap this study is proposed which will focus on the clinical significance of modified cervical and shoulder retraction exercises on pain, disability, and Cobb's angle in the management of non-specific neck pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, retraction, disability, cervical traction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Cervical and Shoulder Retraction exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Cervical Extension Traction exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Modified Cervical and Shoulder Retraction exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cervical Extension Traction exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
NPRS for pain
Description
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).
Time Frame
6th week
Title
NDI for disability
Description
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
Time Frame
6th week
Title
Lateral cervical radiograph for Cobb's angle
Description
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.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neck pain history Patients with Lateral Cervical Radiograph Patients who agreed for a follow up of 6 weeks Exclusion Criteria: Congenital abnormalities e.g. torticollis Past surgical history of cervical spine Positive VBI sign Patients with inflammatory or rheumatic diseases Already undergoing physiotherapy treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy department Services Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatima Saqib, MSPT-OM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34204590
Citation
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.
Results Reference
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PubMed Identifier
33511839
Citation
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.
Results Reference
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PubMed Identifier
32475094
Citation
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.
Results Reference
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PubMed Identifier
33139256
Citation
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.
Results Reference
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PubMed Identifier
34715847
Citation
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.
Results Reference
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PubMed Identifier
32517732
Citation
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.
Results Reference
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PubMed Identifier
32119582
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
34658525
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Effects of Cervical Extension Traction With & Without Modified Cervical and Shoulder Retraction Exercises in Neck Pain

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