NCT04834895

Brief Summary

In study, the researchers examine the effectiveness of digital-based exercises in patients with chronic neck pain.The planned study has 2 main objectives:

  • Increase exercise adherence with mhealth apps.
  • To reduce pain and disability of patients with chronic neck pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

February 21, 2021

Last Update Submit

April 6, 2021

Conditions

Neck Pain

Keywords

Neck painexercisedigital healthmHealthadherence

Outcome Measures

Primary Outcomes (2)

  • Change from Visual Analog Scale (VAS) score at 6 Weeks

    VAS is the most commonly used method to assess pain intensity. The leftmost value in the 10 cm horizontal line used for VAS is scored between 0 cm (no pain) and the rightmost value is between 10 cm (unbearable pain) (Boonstra, Schiphorst Preuper et al. 2008). Measurements were recorded at the beginning and end of exercise training for both groups.

    Baseline and Week 6

  • Change from Exercise Adherence Scale Points at 6 Weeks

    It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence.

    Baseline and Week 6

Secondary Outcomes (1)

  • Change from Neck Pain and Disability Index Points at 6 Weeks

    Baseline and Week 6

Other Outcomes (1)

  • Change from The Nordic Musculoskeletal Questionnaire at 6 Weeks

    Baseline and Week 6

Study Arms (2)

mhealth exercise group

ACTIVE COMPARATOR

home exercise program is given to patients via mobile application

Other: mhealth exercise group

brochure exercise group

EXPERIMENTAL

home exercise program is given to patients via brochure

Other: brochure exercise group

Interventions

mhealth exercise groupOTHER

Participants were asked to perform 18 exercises specially prepared for neck pain in the M.ü Neck Exercises application according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks

mhealth exercise group
brochure exercise groupOTHER

Participants were asked to perform 18 exercises specially prepared for neck pain in the brochure according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks

brochure exercise group

Eligibility Criteria

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

You may qualify if:

  • Neck pain that has been going on for at least 3 months
  • Participant can use smart phone,
  • No problem affecting reading and answering survey questions

You may not qualify if:

  • Presence of visual and auditory problems that may prevent the use of the smartphone application
  • Torticollis
  • Vertigo
  • Pregnancy
  • Additional diseases such as vertebrobasilar insufficiency, heart failure, chronic heart disease and hypertension
  • Dementia
  • Inflammatory rheumatic disease
  • Psychosis and neurological disease diagnosis
  • Receiving another treatment or having surgery in 3 months
  • Exposure to any neck trauma in the past 6 months
  • A past or ongoing cancer history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Eda TONGA

CONTACT

90 216 330 20 70eda.tonga@marmara.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Philosopy

Study Record Dates

First Submitted

February 21, 2021

First Posted

April 8, 2021

Study Start

February 1, 2021

Primary Completion

July 20, 2021

Study Completion

July 30, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

TU(1)