EvaluationNCT03856333
Cognitive Exercise Therapy Approach Scale in Patients With Chronic Neck Pain
A study testing Assigned Interventions in people with Evaluation and Treatment, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Evaluation, Treatment
- What is being tested?
- Assigned Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteCyprus
- Study dates
- 31 Jan 2019to 24 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with previous neck surgery history
- Not willing to participate in the study
- Attract trouble understanding for filling scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Validity, Reliability and Responsiveness of Cognitive Exercise Therapy Approach Scale in Patients With Chronic Neck Pain
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.
Read the 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.
- Conditions
- Evaluation, Treatment
- Being tested
- Assigned Interventions
- Keywords
- Cognitive Exercise Therapy Approach Scale, validity, reliability, responsiveness, neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsOther
exercises, physical agents
| Study group | Role | What they receive |
|---|---|---|
| traditional treatment | Other | 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. Receives: Other: Assigned Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from the baseline will be assesed at the first week and at the third week.
Secondary outcomes (5)
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.
Measured: At the beginning and 2 weeks after the start of treatment
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.
Measured: At the beginning and 2 weeks after the start of treatment
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.
Measured: At the beginning and 2 weeks after the start of treatment
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 .
Measured: At the beginning and 2 weeks after the start of treatment
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
Measured: At the beginning, and 2 weeks after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start31 Jan 2019
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Şahin, Eastern Mediterranean University
- Investigators
- Özge Şahin, Principal investigator, EMUSevim Öksüz, PhD, Study director, EMUEnder Angın, PhD, Study director, EMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856333
- Sponsor's protocol ID
- OZ 1313
- Status last verified
- Mar 2020
- First submitted
- 18 Feb 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not ethical
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Validity, Reliability and Responsiveness of Cognitive Exercise Therapy Approach Scale in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT03856333
- Acronym / sponsor ID
- OZ 1313
- Conditions
- Evaluation, Treatment
- Keywords
- Cognitive Exercise Therapy Approach Scale, validity, reliability, responsiveness, neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| traditional treatment | Other | Other: Assigned Interventions30 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with previous neck surgery history
- Not willing to participate in the study
- Attract trouble understanding for filling scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assigned Interventionsexercises, physical agents | Other | traditional treatment |
Primary outcome
Cognitive Exercise Therapy Approach Scale (BETY)
Time frame: Change from the baseline will be assesed at the first week and at the third week.
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
5 secondary outcomes
Neck Disability Index (NDI)
Time frame: At the beginning and 2 weeks after the start of treatment
Arm, Shoulder and Hand Problems Questionnaire (DASH)
Time frame: At the beginning and 2 weeks after the start of treatment
Hospital Anxiety and Depression Scale (HADS)
Time frame: At the beginning and 2 weeks after the start of treatment
Short Form-36 (SF-36)
Time frame: At the beginning and 2 weeks after the start of treatment
Visual Analogue Scale (VAS)
Time frame: At the beginning, and 2 weeks after the start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No. Not ethical
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özge Şahin principal investigator
EMU
Sevim Öksüz, PhD study director
EMU
Ender Angın, PhD study director
EMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions in people with Evaluation and Treatment, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Exercise Therapy Approach Scale (BETY) (time frame: Change from the baseline will be assesed at the first week and at the third week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.