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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04831931
Other study ID # C92F2628X5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2020
Est. completion date March 19, 2021

Study information

Verified date April 2021
Source Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Neck pain is a common musculoskeletal problem occurring as one of the first conditions causing decreased quality of life and disability. An estimated 67.5% of people experience neck pain in their lives (5, 6). When the adult population is considered (15-74 years old), the prevalence ranges from 5.9% to 38.7%. Causes of neck pain are largely variable, and include working in unsuitable ergonomic positions, sitting for a long time, and keeping the neck in abnormal physiological position for a long time. Various factors are effective in the chronic stage of neck pain. Neck pain is associated with decreased strength and endurance of the cervical muscles. It was observed that deep flexor muscles are weak and superficial flexor muscle activity is increased in patients with neck pain; and that exercise is effective in reducing neck pain because strength, endurance, and flexibility can be regained in the structures around the damaged tissue. There are several approaches that were found to be effective in the treatment of neck pain. These treatment strategies include physical therapy modalities, manual therapy, therapeutic exercise (stretching, strengthening, and endurance exercises) and home exercise programs. Home exercise programs are used to expand the clinic-based physical therapy approaches to treat neck pain. It was stated that it is now compulsory to develop new rehabilitation models and practices to cope with global increase in elderly population, limited resources allocated to public health, and changes in population needs. Telerehabilitation is recommended as a solution to provide physical therapy services; however, it was reported in previous studies that more studies are required in this field to accept its effectiveness. The purpose of the present study is to examine the effects of 4-week exercise protocol established with stretching, strengthening the scapula muscles for the neck and upper body, neck and core stabilization exercises by ensuring the follow-up of the patients with Telerehabilitation Method on patients' neck pain, Daily Life Activities (DLA), and quality of life by comparing its effects with individuals who apply only home program.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date March 19, 2021
Est. primary completion date November 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - voluntary individuals suffering from neck pain for at least 3 months - over the age of 18 - have a minimum score of 3/10 according to the Numeric Pain Rating Scale - who fill out the pain preliminary information form, and who will agree to participate in the study through this form. Exclusion Criteria: - Pregnant women, - History of malignancy - Congenital deformities or surgery history in the neck or shoulder area - perception problems for verbal commands - not having internet access - not having equipment to make video calls

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise Program Applied by Telerehabilitation
Patients will be evaluated 3 times for 4 weeks throughout the study; before the study commences, at the end of 2th and 4th week Exercises will be planned to last for 15 minutes a day, and will be progressed and changed weekly throughout the study period. To the exercise program; It will be created as a progressive program by including stretching, normal range of motion movements, neck, core and scapular stabilization and strengthening exercises and the same program will be given to both groups.

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (22)

Aydemir Ö., Köroglu E., Psikiyatride Kullanilan Klinik Ölçekler. 3'üncü baski. Ankara. Hekimler Yayin Birligi , 2007; 346-353

Bicer A, Yazici A, Camdeviren H, Erdogan C. Assessment of pain and disability in patients with chronic neck pain: reliability and construct validity of the Turkish version of the neck pain and disability scale. Disabil Rehabil. 2004 Aug 19;26(16):959-62. — View Citation

Christensen JO, Knardahl S. Time-course of occupational psychological and social factors as predictors of new-onset and persistent neck pain: a three-wave prospective study over 4 years. Pain. 2014 Jul;155(7):1262-1271. doi: 10.1016/j.pain.2014.03.021. Epub 2014 Apr 2. — View Citation

Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221. Review. — View Citation

Edmondston SJ, Wallumrød ME, Macléid F, Kvamme LS, Joebges S, Brabham GC. Reliability of isometric muscle endurance tests in subjects with postural neck pain. J Manipulative Physiol Ther. 2008 Jun;31(5):348-54. doi: 10.1016/j.jmpt.2008.04.010. — View Citation

Eser E, Fidaner H, Fidaner C, Eser SY ve ark. Psychometric properties of WHOQOL-100 and WHOQOL-BREF. 3P Dergisi 1999;7(2 Suppl.):23-40

Eser SY, Fidaner H, Fidaner C, Elbi H ve ark. Measure of quality of life WHOQOL-100 and WHOQOL-Bref. 3P Dergisi 1999;7(2 Suppl.):5-13.

Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. Epub 2005 Jul 6. Review. — View Citation

Galea MD. Telemedicine in Rehabilitation. Phys Med Rehabil Clin N Am. 2019 May;30(2):473-483. doi: 10.1016/j.pmr.2018.12.002. Epub 2019 Mar 5. Review. — View Citation

Hailey D, Roine R, Ohinmaa A, Dennett L. Evidence of benefit from telerehabilitation in routine care: a systematic review. J Telemed Telecare. 2011;17(6):281-7. doi: 10.1258/jtt.2011.101208. Epub 2011 Aug 15. Review. — View Citation

Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for asse — View Citation

Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9. — View Citation

Mäkelä M, Heliövaara M, Sievers K, Impivaara O, Knekt P, Aromaa A. Prevalence, determinants, and consequences of chronic neck pain in Finland. Am J Epidemiol. 1991 Dec 1;134(11):1356-67. — View Citation

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 201 — View Citation

May S, Gardiner E, Young S, Klaber-Moffett J. Predictor Variables for a Positive Long-Term Functional Outcome in Patients with Acute and Chronic Neck and Back Pain Treated with a McKenzie Approach: A Secondary Analysis. J Man Manip Ther. 2008;16(3):155-60. — View Citation

Moffett J, McLean S. The role of physiotherapy in the management of non-specific back pain and neck pain. Rheumatology (Oxford). 2006 Apr;45(4):371-8. Epub 2005 Dec 6. Review. — View Citation

Peterson C, Bolton J, Humphreys BK. Predictors of outcome in neck pain patients undergoing chiropractic care: comparison of acute and chronic patients. Chiropr Man Therap. 2012 Aug 24;20(1):27. doi: 10.1186/2045-709X-20-27. — View Citation

Rogante M, Grigioni M, Cordella D, Giacomozzi C. Ten years of telerehabilitation: A literature overview of technologies and clinical applications. NeuroRehabilitation. 2010;27(4):287-304. doi: 10.3233/NRE-2010-0612. Review. — View Citation

Sebastian D, Chovvath R, Malladi R. Cervical extensor endurance test: a reliability study. J Bodyw Mov Ther. 2015 Apr;19(2):213-6. doi: 10.1016/j.jbmt.2014.04.014. Epub 2014 Apr 18. — View Citation

Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15. Erratum in: J Manipulative Physiol Ther 1992 Jan;15(1):followi. — View Citation

Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32. Review. — View Citation

Zronek M, Sanker H, Newcomb J, Donaldson M. The influence of home exercise programs for patients with non-specific or specific neck pain: a systematic review of the literature. J Man Manip Ther. 2016 May;24(2):62-73. doi: 10.1179/2042618613Y.0000000047. Review. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale Numeric Pain Rating Scale (NPRS) will be used to evaluate pain subjectively. NPRS is used to evaluate pain. The patient is asked to rate the severity of pain over 10, 0 showing no pain, and 10 showing the worst pain score. Validity and validation of the use of NPRS to evaluate chronic pain in the literature with face-to-face and telepresentation methods.
Its reliability has been reported
4 weeks
Primary Deep Neck Flexor Endurance Test Patients are asked to lie on a flat ground in the form of a "hook" during the online video conference. They are then asked to move their jaws closer to their chests in the Chin Tuck Position, raise their heads approximately 2.5 cm, and remain in this position. If patients experience any pain and fatigue or put their heads back on the floor, the test is terminated. The physiotherapist keeps track of the patient during this period. Two measurements are made, and the long-lasting result is recorded. The validity and reliability of the evaluation has been demonstrated by the online video videoconferencing method. 4 weeks
Secondary Neck Disability Index (NDI) The level of disability associated with the neck pain will be evaluated with the Neck Disability Index. The NDI consists of 10 sections that include pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/job, driving, sleep, and social activities. Each question has 6 answer options measuring the severity of pain or limitation. Scoring is done between 0 and 5. The highest score is 50, and the minimum score in 0.
According to the total score; 0-4 means no limitation, 5-14 means slight limitation, 15-24 moderate limitation, 25-34 severe limitation, 34 and above completely limitation . The Turkish validity and reliability study of the survey was conducted.
4 weeks
Secondary World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref) There are two versions of this scale as the long (WHOQOLS-100) and short (WHOQOLS-27) form. The scale measures the bodily, spiritual, social, and environmental well-being of the individual, and consists of 26 questions. The Turkish version consists of 27 questions. The 27th question is the national question determining the Environmental Area Score. The scale can be applied to non-elderly adults . The field scores are calculated between 4 and 20 because each field refers to the quality of life in the relevant field independently from each other. As the score increases, the quality of life increases. The Turkish validity and reliability study of the scale was conducted . 4 weeks
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