NCT06818422

Brief Summary

Brief Summary Neck pain is a common global health issue, often classified as nonspecific neck pain when no specific cause is identified. This study aims to compare the effectiveness of telemedicine (which involves providing home exercises and recommendations through pre-recorded exercise videos and remote follow-up) versus conventional care (which involves providing home exercises and recommendations through informational brochures and in-person follow-ups) for patients with nonspecific neck pain. Participants will be randomly assigned to either group. The primary outcomes are pain intensity (VAS) and neck function (NDI), with secondary outcomes including exercise adherence, patient satisfaction, and time and distance spent for in-patient follow-ups. The study hypothesizes that telemedicine will result in greater pain reduction, improved neck function, and higher patient satisfaction due to the convenience and accessibility of video-based exercises. If proven effective, telemedicine could reduce hospital crowding, minimize infection risks, save time and money, and reduce environmental impacts, making it a valuable tool in non-serious pathologies and during events like pandemics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

February 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

February 5, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

neck painhome exercisetelemedicineteleexercise

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    Pain intensity will be measured using the Visual Analog Scale (VAS). Minimum value is 0 (no pain), maximum value is 10 (most imaginable pain).

    Baseline, 15th day, 30th day and 3rd month

  • Neck function

    Neck function will be assessed using the Neck Disability Index (NDI). Minimum value is 0 (no disability), maximum value is 50 (maximum disability).

    Baseline and 3rd month

Secondary Outcomes (4)

  • Adherence to the exercise program

    15th day

  • Patient satisfaction

    3rd month

  • Transportation distance

    Baseline

  • The time spent

    Baseline

Study Arms (2)

Telemedicine Group

EXPERIMENTAL

Patients will receive pre-recorded neck exercise and educational videos sent to their phones by the physician. They will follow the exercise routine at home three times a day for 2 weeks, based on the provided videos. They will mark the exercise diary given to them when they do their exercises. They will be advised to continue exercise program for 3 months. Additionally, the physician will conduct video calls to monitor their pain levels and offer support at the 15th day, 30th day and the 3rd month of the study.

Other: Home exercise and recommendations for nonspecific neck pain

Conventional Follow-up Group

ACTIVE COMPARATOR

Patients will receive an exercise brochure and a brochure with educational recommendations given by a physician face-to-face in the clinic. These patients will follow the exercise routine at home three times a day for 2 weeks, based on the provided brochures. They will mark the exercise diary given to them when they do their exercises. They will also be advised to continue exercises for 3 months. They will be come to clinic check-ups to monitor pain intensity and provide support at the 15th day, 30th day and the 3rd month of the study.

Other: Home exercise and recommendations for nonspecific neck pain

Interventions

The intervention involves neck exercises and recommendations for nonspecific neck pain. Patients will perform the exercises at home three times a day for 2 weeks and record their progress in an exercise diary. They will be monitored by a physician for pain levels and receive additional support at the 15th day, 30th day and 3rd months.

Conventional Follow-up GroupTelemedicine Group

Eligibility Criteria

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

You may qualify if:

  • Non-specific neck pain for at least 3 months (neck pain without a specific underlying cause such as infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder or radicular symptoms)
  • Clinical and/or radiological presence of one of the following diagnoses: cervicalgia, cervical flattening, cervical arthrosis, cervical discopathy
  • Able to understand and apply the given exercises; literate and therefore able to read and interpret the given brochure; familiar with smartphones, tablets and computers, able to use them easily, able to open and watch sent videos, have internet access

You may not qualify if:

  • Having a cognitive disorder
  • Red flag findings indicating serious pathology, recent trauma to the neck region, fracture, lysis, listhesis, spinal mass and malignancy, syringomyelia, presence of canal stenosis
  • Having undergone surgery in the cervical region
  • Having received injections to the neck and back region in the last 3 months
  • Having received physical therapy or home exercise recommendations in the same hospital or in another center in the last 3 months
  • Not having their own smartphone or smart tablet and/or uninterrupted internet access
  • Having a visual impairment
  • Having an upper extremity amputation
  • Having advanced cancer, receiving cancer treatment
  • Having complicated diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Selkin Yılmaz Muluk

Antalya, 07040, Turkey (Türkiye)

Location

Antalya City Hospital

Antalya, Turkey (Türkiye)

Location

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (6)

  • Fandim JV, Nitzsche R, Michaleff ZA, Pena Costa LO, Saragiotto B. The contemporary management of neck pain in adults. Pain Manag. 2021 Jan;11(1):75-87. doi: 10.2217/pmt-2020-0046. Epub 2020 Nov 25.

    PMID: 33234017BACKGROUND
  • Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1.

    PMID: 18758050BACKGROUND
  • Guzman J, Hurwitz EL, Carroll LJ, Haldeman S, Cote P, Carragee EJ, Peloso PM, van der Velde G, Holm LW, Hogg-Johnson S, Nordin M, Cassidy JD. A new conceptual model of neck pain: linking onset, course, and care: the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S17-28. doi: 10.1016/j.jmpt.2008.11.007.

    PMID: 19251062BACKGROUND
  • Bier JD, Scholten-Peeters WGM, Staal JB, Pool J, van Tulder MW, Beekman E, Knoop J, Meerhoff G, Verhagen AP. Clinical Practice Guideline for Physical Therapy Assessment and Treatment in Patients With Nonspecific Neck Pain. Phys Ther. 2018 Mar 1;98(3):162-171. doi: 10.1093/ptj/pzx118.

    PMID: 29228289BACKGROUND
  • Corp N, Mansell G, Stynes S, Wynne-Jones G, Morso L, Hill JC, van der Windt DA. Evidence-based treatment recommendations for neck and low back pain across Europe: A systematic review of guidelines. Eur J Pain. 2021 Feb;25(2):275-295. doi: 10.1002/ejp.1679. Epub 2020 Nov 12.

    PMID: 33064878BACKGROUND
  • Swenson RS. Therapeutic modalities in the management of nonspecific neck pain. Phys Med Rehabil Clin N Am. 2003 Aug;14(3):605-27. doi: 10.1016/s1047-9651(03)00038-x.

    PMID: 12948344BACKGROUND

Related Links

MeSH Terms

Conditions

Neck PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Selkin Yılmaz Muluk, MD

    Antalya Training and Research Hospital, Antalya City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be unaware of the procedures used in the other group. Additionally, the outcome assessor will be blinded to group assignments during the statistical analysis to prevent bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled clinical study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 10, 2025

Study Start

February 10, 2025

Primary Completion

June 13, 2025

Study Completion

June 15, 2025

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

I am planning to share a portion of the study plan, specifically the plan description section, with the public. This will provide transparency and allow for greater engagement with the community regarding our research objectives and methodology.

Shared Documents
STUDY PROTOCOL
Time Frame
I plan to share the study protocol with the public once it has received the necessary approvals from the relevant authorities.
Access Criteria
Access to the study protocol will be granted to individuals and organizations interested in our research, subject to the approval of the relevant ethical and regulatory bodies. This includes researchers, healthcare professionals, and members of the public who seek to understand the study's objectives and methodology

Locations