- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05391997
Effects of Cervical Extension Traction With & Without Modified Cervical and Shoulder Retraction Exercises in Neck Pain
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Physiotherapy department Services Hospital Lahore
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Principal Investigator:
- Fatima Saqib, MSPT-OM
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Modified Cervical and Shoulder Retraction exercises
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.
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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.
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Active Comparator: Cervical Extension Traction exercises
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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NPRS for pain
Time Frame: 6th week
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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).
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6th week
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NDI for disability
Time Frame: 6th week
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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
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6th week
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Lateral cervical radiograph for Cobb's angle
Time Frame: 6th week
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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.
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6th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Salman Bashir, PhD, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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