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Different Home Exercise Programs in Neck Pain

Primary Purpose

Neck Pain, Exercise Training

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group 1 (printed materials)
Group 2 (video phone reminder)
Sponsored by
Özden Laçin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • İstanbul Arel University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1 (printed materials),

Group 2 (video phone reminder)

Arm Description

Group 1 was given home exercise method with printed materials

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

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

Full Information

First Posted
October 14, 2019
Last Updated
February 7, 2020
Sponsor
Özden Laçin
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1. Study Identification

Unique Protocol Identification Number
NCT04135144
Brief Title
Different Home Exercise Programs in Neck Pain
Official Title
Comparison of the Effects of Two Different Home Exercise Programs in Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Özden Laçin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Both groups were prescribed the same type of exercise, duration of exercise and number of repetitions. group 1 completed the exercise program and marked the exercise attendance schedule. At the end of the program, these charts were collected from the subjects and the continuity was evaluated. The group marked the exercises completed with 2 phone app. In the program used, exercise continuity of the cases was evaluated as days. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Exercise Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (printed materials),
Arm Type
Active Comparator
Arm Description
Group 1 was given home exercise method with printed materials
Arm Title
Group 2 (video phone reminder)
Arm Type
Active Comparator
Arm Description
Group 2 was given exercise with home exercise method with video phone reminder
Intervention Type
Other
Intervention Name(s)
Group 1 (printed materials)
Other Intervention Name(s)
home exercise with printed materials
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group 2 (video phone reminder)
Other Intervention Name(s)
home exercise with video phone reminder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neck disability
Description
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.
Time Frame
6 weeks
Title
Pain intensity
Description
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)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: complaint of neck pain, Being between 25-60 years of age Exclusion Criteria: taking painkillers regularly, undergoing any neck surgery and severe trauma, presence of any diagnosed neck disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özden Laçin
Organizational Affiliation
İstanbul Arel Uiversity
Official's Role
Study Director
Facility Information:
Facility Name
İstanbul Arel University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Different Home Exercise Programs in Neck Pain

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