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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05391997
Other study ID # REC/RCR & AHS/22/0117
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date January 1, 2023

Study information

Verified date May 2022
Source Riphah International University
Contact Imran Amjad, PhD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 22
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 25 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Modified Cervical and Shoulder Retraction exercises
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.
Cervical Extension Traction 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

Locations

Country Name City State
Pakistan Physiotherapy department Services Hospital Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

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. pii: bjsports-2020-102664. doi: 10.1136/bjsports-2020-102664. [Epub ahead of print] Review. — View Citation

Jahre H, Grotle M, Smedbråten K, Dunn KM, Øiestad 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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View Citation

Multanen J, Häkkinen 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. — View 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. Review. — View 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. — View 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). pii: 746. doi: 10.3390/healthcare9060746. Review. — View Citation

Villanueva-Ruiz I, Falla D, Lascurain-Aguirrebeña 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). pii: pzab259. doi: 10.1093/ptj/pzab259. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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