NCT04135144

Brief Summary

Purpose: The aim of this study was to compare the effects of two different home exercise methods on exercise compliance, neck pain and neck disability in individuals with neck pain. Material and metods: The study, carried out between February 2018 and May 2018 at Istanbul Arel University Vocational School, was performed with 60 people aged 25-60 years who were suffering from neck pain in academic and administrative staff. The cases were randomly divided into two groups. In Group 1, the case was given home exercise method (B.M.E.Y) with printed materials whereas Group 2 was given exercise with home exercise method (V.H.E.Y) with video phone reminder. Pain intensity was evaluated before and after exercise with 'Visual Analog Scale' (VAS), whereas the level of neck disability was evaluated before and after exercise with 'Neck Pain and Disability Score' (NPDS). The obtained results were analyzed using appropriate statistical methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

October 14, 2019

Last Update Submit

February 7, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Neck disability

    Self reported. The level of neck disability was evaluated before and after exercise with 'Neck Pain and Disability Score' . Each question is measured on a scale from 0 (no disability) to 5, and an overall score out of 100 is calculated by adding each item score together.

    6 weeks

  • Pain intensity

    Self reported pain intensity .. Pain intensity was evaluated before and after exercise with 'Visual Analog Scale'. Each item scored is 0-10 (0=no pain 10=pain as bad as can be)

    6 weeks

Study Arms (2)

Group 1 (printed materials),

ACTIVE COMPARATOR

Group 1 was given home exercise method with printed materials

Other: Group 1 (printed materials)

Group 2 (video phone reminder)

ACTIVE COMPARATOR

Group 2 was given exercise with home exercise method with video phone reminder

Other: Group 2 (video phone reminder)

Interventions

Exercises were given at least 3 times a week for 10 weeks and 1 set per day for a total of 6 weeks. individuals; normal joint movement exercises; neck flexion, lateral flexion, rotation, extension and retraction movements, isometric exercises; neck flexion, extension, lateral flexion and rotation movements and stretching exercises; neck lateral flexion, neck rotation and flexion movements were given.

Also known as: home exercise with printed materials
Group 1 (printed materials),

Exercises were given at least 3 times a week for 10 weeks and 1 set per day for a total of 6 weeks. individuals; normal joint movement exercises; neck flexion, lateral flexion, rotation, extension and retraction movements, isometric exercises; neck flexion, extension, lateral flexion and rotation movements and stretching exercises; neck lateral flexion, neck rotation and flexion movements were given.

Also known as: home exercise with video phone reminder
Group 2 (video phone reminder)

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • complaint of neck pain,
  • Being between 25-60 years of age

You may not qualify if:

  • taking painkillers regularly,
  • undergoing any neck surgery and severe trauma,
  • presence of any diagnosed neck disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Arel University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Özden Laçin

    İstanbul Arel Uiversity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 22, 2019

Study Start

February 1, 2018

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations