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Cognitive Exercise Therapy Approach Scale in Patients With Chronic Neck Pain

Primary Purpose

Evaluation, Treatment

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Assigned Interventions
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Evaluation focused on measuring Cognitive Exercise Therapy Approach Scale, validity, reliability, responsiveness, neck pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals aged between 18-65 years
  • Neck pain VAS out of 3 and above which individuals
  • Individuals who have neck pain for more than 3 months

Exclusion Criteria:

  • Patients with previous neck surgery history
  • Not willing to participate in the study
  • Attract trouble understanding for filling scale

Sites / Locations

  • Özge Şahin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

traditional treatment

Arm Description

30 minutes of conventional TENS, 20 minutes of hotpack, 8 minutes of therapeutic ultrasound and isotonic, isometric, stretching and relaxation exercises 2 weeks, 5 days in a week.

Outcomes

Primary Outcome Measures

Cognitive Exercise Therapy Approach Scale (BETY)
The biopsychosocial process associated with the neck pain will be evaluated by the 'Cognitive Exercise Therapy Approach Scale'. The scale consists of 30 items. The scale was scored using a 5-point Likert system. Every question; No in no time: 0, Yes rarely: 1, Yes sometimes: 2, Yes often: 3, Yes is always scored as 4: and gives a total score of 30 items. High score means low biopsychosocial status assessment is "bad

Secondary Outcome Measures

Neck Disability Index (NDI)
It is used to assess the disability caused by neck pain. The index consists of 10 chapters including the severity of pain, personal care, lifting, reading, headache, concentration, working life, driving, sleep and leisure time. There are 6 responses for each section, 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). There was no apology between 0-4 points in the NDI, mild disability between 5-14 points, moderate disability between 15-24 points, severe apology between 25-34 points and full disability over 35 points . The Turkish validity and reliability study was conducted by Aslan et al.
Arm, Shoulder and Hand Problems Questionnaire (DASH)
It is a scale used to evaluate the functional disability associated with upper extremity. The scale consists of three parts. DASH has a total of 30 questions and includes 8 questions for people who are engaged in work and social activities. In case of not answering more than 3 questions, the questionnaire is considered invalid. Response options in scale are between 1 and 5. Scoring for each section is calculated as 0-100. High scores indicate serious activity limitations . The scale is valid, reliable and sensitive to changes. The Turkish cultural adaptation was also made and the scale was found to be valid and reliable for the Turkish version.
Hospital Anxiety and Depression Scale (HADS)
The area of use of the scale is not to diagnose, but to reveal the depression and anxiety associated with existing diseases. It has been widely used in a variety of somatic, psychiatric and primary care populations and in many chronic diseases such as musculoskeletal, cancer, end-stage renal disease, and has been found to be able to measure depression and anxiety significantly . It is a 14-item scale consisting of seven anxiety-related subscales (HADS-A) and depression subscale (HADS-D). Each question is scored between 0 and 3 and is interpreted according to the total score. Although the total score indicates the increased level of anxiety and depression, it can be interpreted as being 'normal' between 0-7, being between 8-10, 'borderline normal', and between 11-21 being 'abnormal'. The Turkish validity and reliability study was conducted by Aydemir et al.
Short Form-36 (SF-36)
This questionnaire, which evaluates the quality of life of the person, consists of 36 questions on eight sub-scales: physical function, physical role restriction, emotional role restriction, body pain, social function, mental health, vitality, and general health. The scores are scored separately for each subscale and the scores range from 0 to 100. 100 points indicate good health status, while 0 points indicate poor health status . The reliability and validity study of Turkish by Koçyiğit et al .
Visual Analogue Scale (VAS)
The pain intensity of individuals was questioned by Vizel Analog Scale. VAS is a method used in numerical form to quantify non-measured values. It is often preferred because it can be easily applied and repeated in a short time. The parameter to be evaluated in a horizontal line of 10 centimeters is written to define both endpoints and the patient is asked to mark the appropriate point for the parameter evaluated on this 10-centimeter line. The severity of the patient's pain is determined by measuring the length of the distance from the point of pain to the point determined by the patient

Full Information

First Posted
February 18, 2019
Last Updated
March 8, 2020
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT03856333
Brief Title
Cognitive Exercise Therapy Approach Scale in Patients With Chronic Neck Pain
Official Title
Determining the Validity, Reliability and Responsiveness of Cognitive Exercise Therapy Approach Scale in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
January 24, 2020 (Actual)
Study Completion Date
January 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

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
The aim of this study was to determine the validity, reliability and sensitivity of the Cognitive Exercise Therapy Approach Scale in patients with neck pain.
Detailed Description
According to the power analyzes 199 neck pain patients will be taken to the study.The study will be initiated after the approval of the Ethics Committee of the Eastern Mediterranean University Faculty of Health Sciences. After informing about the content of the study, individuals who want to participate in the study will be asked to sign the informed consent form. In order to evaluate the validity and reliability of the BETY scale in the study, the same individuals will be given a test-retest with 1 week intervals. In these tests, the Neck Disability Index (NDI), Arm Shoulder and Hand Problems Questionnaire (DASH), Short Form-36 (SF-36), Hospital Anxiety and Depression Scale (HADS) and BETY scale will be applied.In order to assess the sensitivity to change, 44 individuals will be asked to re-fill the forms after the traditional physiotherapy program for neck pain, which will be administered 10 sessions. For 2 weeks, a routine exercise program consisting of 20 minutes of conventional TENS, 20 minutes of hotpack, 8 minutes of therapeutic ultrasound and isotonic, isometric, stretching and relaxation exercises will be applied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaluation, Treatment
Keywords
Cognitive Exercise Therapy Approach Scale, validity, reliability, responsiveness, neck pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
traditional treatment
Arm Type
Other
Arm Description
30 minutes of conventional TENS, 20 minutes of hotpack, 8 minutes of therapeutic ultrasound and isotonic, isometric, stretching and relaxation exercises 2 weeks, 5 days in a week.
Intervention Type
Other
Intervention Name(s)
Assigned Interventions
Intervention Description
exercises, physical agents
Primary Outcome Measure Information:
Title
Cognitive Exercise Therapy Approach Scale (BETY)
Description
The biopsychosocial process associated with the neck pain will be evaluated by the 'Cognitive Exercise Therapy Approach Scale'. The scale consists of 30 items. The scale was scored using a 5-point Likert system. Every question; No in no time: 0, Yes rarely: 1, Yes sometimes: 2, Yes often: 3, Yes is always scored as 4: and gives a total score of 30 items. High score means low biopsychosocial status assessment is "bad
Time Frame
Change from the baseline will be assesed at the first week and at the third week.
Secondary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
It is used to assess the disability caused by neck pain. The index consists of 10 chapters including the severity of pain, personal care, lifting, reading, headache, concentration, working life, driving, sleep and leisure time. There are 6 responses for each section, 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). There was no apology between 0-4 points in the NDI, mild disability between 5-14 points, moderate disability between 15-24 points, severe apology between 25-34 points and full disability over 35 points . The Turkish validity and reliability study was conducted by Aslan et al.
Time Frame
At the beginning and 2 weeks after the start of treatment
Title
Arm, Shoulder and Hand Problems Questionnaire (DASH)
Description
It is a scale used to evaluate the functional disability associated with upper extremity. The scale consists of three parts. DASH has a total of 30 questions and includes 8 questions for people who are engaged in work and social activities. In case of not answering more than 3 questions, the questionnaire is considered invalid. Response options in scale are between 1 and 5. Scoring for each section is calculated as 0-100. High scores indicate serious activity limitations . The scale is valid, reliable and sensitive to changes. The Turkish cultural adaptation was also made and the scale was found to be valid and reliable for the Turkish version.
Time Frame
At the beginning and 2 weeks after the start of treatment
Title
Hospital Anxiety and Depression Scale (HADS)
Description
The area of use of the scale is not to diagnose, but to reveal the depression and anxiety associated with existing diseases. It has been widely used in a variety of somatic, psychiatric and primary care populations and in many chronic diseases such as musculoskeletal, cancer, end-stage renal disease, and has been found to be able to measure depression and anxiety significantly . It is a 14-item scale consisting of seven anxiety-related subscales (HADS-A) and depression subscale (HADS-D). Each question is scored between 0 and 3 and is interpreted according to the total score. Although the total score indicates the increased level of anxiety and depression, it can be interpreted as being 'normal' between 0-7, being between 8-10, 'borderline normal', and between 11-21 being 'abnormal'. The Turkish validity and reliability study was conducted by Aydemir et al.
Time Frame
At the beginning and 2 weeks after the start of treatment
Title
Short Form-36 (SF-36)
Description
This questionnaire, which evaluates the quality of life of the person, consists of 36 questions on eight sub-scales: physical function, physical role restriction, emotional role restriction, body pain, social function, mental health, vitality, and general health. The scores are scored separately for each subscale and the scores range from 0 to 100. 100 points indicate good health status, while 0 points indicate poor health status . The reliability and validity study of Turkish by Koçyiğit et al .
Time Frame
At the beginning and 2 weeks after the start of treatment
Title
Visual Analogue Scale (VAS)
Description
The pain intensity of individuals was questioned by Vizel Analog Scale. VAS is a method used in numerical form to quantify non-measured values. It is often preferred because it can be easily applied and repeated in a short time. The parameter to be evaluated in a horizontal line of 10 centimeters is written to define both endpoints and the patient is asked to mark the appropriate point for the parameter evaluated on this 10-centimeter line. The severity of the patient's pain is determined by measuring the length of the distance from the point of pain to the point determined by the patient
Time Frame
At the beginning, and 2 weeks after the start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals aged between 18-65 years Neck pain VAS out of 3 and above which individuals Individuals who have neck pain for more than 3 months Exclusion Criteria: Patients with previous neck surgery history Not willing to participate in the study Attract trouble understanding for filling scale
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özge Şahin
Organizational Affiliation
EMU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sevim Öksüz, PhD
Organizational Affiliation
EMU
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ender Angın, PhD
Organizational Affiliation
EMU
Official's Role
Study Director
Facility Information:
Facility Name
Özge Şahin
City
Famagusta
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not ethical

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Cognitive Exercise Therapy Approach Scale in Patients With Chronic Neck Pain

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