NCT04831931

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

March 31, 2021

Last Update Submit

April 1, 2021

Conditions

Keywords

Neck pain, telerehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Neck Disability Index (NDI)

    4 weeks

  • World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)

    4 weeks

Study Arms (3)

Supervised Exercise Group

EXPERIMENTAL

Telerehabilitation will be applied in this group, which will last 4 weeks, and include the following processes * Exercises that will be performed every Monday will be taught and applied face-to-face under the supervision of the therapist with online videoconferencing method. Then, videos of weekly exercises that will be prepared by the therapist will be transmitted online to patients. * Patients will be asked to perform these exercises 4 days a week in the same week, on Wednesdays, Fridays and Sundays. * Also, a video call will be made on Fridays to evaluate whether the movements are done effectively and correctly, and questions of patients (if any) will be answered. * Patients will be informed by the physiotherapist that they should send messages on Wednesdays and Sundays to show that they are doing the exercises. * The exercise program of new week will be taught every Monday for 4 weeks, the prepared video will be sent, and the program will be advanced and completed.

Other: Exercise Program Applied by Telerehabilitation

Exercise Group

ACTIVE COMPARATOR

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.

Other: Exercise Program Applied by Telerehabilitation

Control Group

NO INTERVENTION

No exercise application will be done in this group.Evaluation tests will be applied for 4 weeks only online.

Interventions

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.

Exercise GroupSupervised Exercise Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

Location

Related Publications (22)

  • 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.

    PMID: 1755449BACKGROUND
  • 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.

    PMID: 15999284BACKGROUND
  • Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.

    PMID: 28807894BACKGROUND
  • 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.

    PMID: 19119405BACKGROUND
  • 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.

    PMID: 22920497BACKGROUND
  • 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.

    PMID: 24704365BACKGROUND
  • Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32.

    PMID: 17369784BACKGROUND
  • 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.

    PMID: 16332949BACKGROUND
  • 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.

    PMID: 27559275BACKGROUND
  • 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.

    PMID: 21844172BACKGROUND
  • 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.

    PMID: 21160118BACKGROUND
  • 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.

    PMID: 30954160BACKGROUND
  • 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.

  • 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.

  • 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.

  • Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

  • 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

    RESULT
  • 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

    RESULT
  • 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.

    RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

October 30, 2020

Primary Completion

November 30, 2020

Study Completion

March 19, 2021

Last Updated

April 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations