- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04831931
The Effectiveness of the Exercise Program Applied by Telerehabilitation Method in Individuals With Chronic Neck Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34810
- Istanbul Medipol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 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 |
---|---|
Experimental: Supervised Exercise Group
Telerehabilitation will be applied in this group, which will last 4 weeks, and include the following processes
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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. |
Active Comparator: Exercise Group
Exercise recommendations will be made to this group.
Videos and photographs of weekly exercises prepared by the therapist will be sent online to the patient every Monday for 4 weeks, patients will be advised to repeat these exercises 4 days a week.
|
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. |
No Intervention: Control Group
No exercise application will be done in this group.Evaluation tests will be applied for 4 weeks only online.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale
Time Frame: 4 weeks
|
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
|
Deep Neck Flexor Endurance Test
Time Frame: 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index (NDI)
Time Frame: 4 weeks
|
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
|
World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)
Time Frame: 4 weeks
|
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 .
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4 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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 assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
- 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. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
- 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.
- 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.
- Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
- 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.
- 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.
- Makela M, Heliovaara 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. doi: 10.1093/oxfordjournals.aje.a116038.
- 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. doi: 10.1179/jmt.2008.16.3.155.
- 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.
- Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32.
- 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. doi: 10.1093/rheumatology/kei242. Epub 2005 Dec 6.
- 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.
- 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.
- 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.
- 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 2019 Jul 4.
- Edmondston SJ, Wallumrod ME, Macleid 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.
- 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.
- 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. doi: 10.1080/09638280410001696755.
- Aydemir Ö., Köroğlu E., Psikiyatride Kullanılan Klinik Ölçekler. 3'üncü baskı. Ankara. Hekimler Yayın Birliği , 2007; 346-353
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- C92F2628X5
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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