| CTRI Number |
CTRI/2024/12/077714 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
cross cultural adaptation of Cognitive Behavior Questionnaire in Low Back Pain |
|
Scientific Title of Study
|
Turkish Adaptation, Validity and Reliability Study of the Cognitive Behavior Questionnaire in Non-Specific Chronic Low Back Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Saini |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Vidyapeeth |
| Address |
room no 2, Physiotherapy Department,
Dr D Y Patil Vidyapeeth, Pune, India
190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seemasaini80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Seema Saini |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Vidyapeeth |
| Address |
room no 2, Physiotherapy Department,
Dr D Y Patil Vidyapeeth, Pune, India
190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seemasaini80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Seema Saini |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Vidyapeeth |
| Address |
room no 2, Physiotherapy Department,
Dr D Y Patil Vidyapeeth, Pune, India
190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seemasaini80@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Vidyapeeth |
| Address |
190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| stanbul Medipol University |
Kavacık Mah Ekinciler Cad No: 19 Kavacık Kavşağı 34810 Beykoz İstanbul |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Seema Saini |
Dr D Y Patil College of Physiotherapy |
190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
08087564345
seemasaini80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Non-Invasive Clinical Research Ethics Committee Council |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants ages ranging from 18 to 65 were eligible for inclusion who had experienced low
back pain for a minimum duration of six months and if pain was exacerbated by changes in
posture, movement, or physical activity. |
|
| ExclusionCriteria |
| Details |
Individuals who had undergone surgery for low back pain, received any medical procedures
such as facet or sacroiliac joint injections, myofascial trigger point injections, or denervation
procedures within the past three months were excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Oswestry Disability Index (ODI), Back Pain Attitudes Questionnaire (Back-PAQ), Fear
Avoidance Beliefs Questionnaire (FABQ), Tampa Kinesiophobia Scale (TKS), Beck Anxiety
Inventory (BAI) and Beck Depression Inventory (BDI) were administered to individuals with
chronic low back pain. |
0 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fear
Avoidance Beliefs Questionnaire (FABQ), Tampa Kinesiophobia Scale (TKS), Beck Anxiety
Inventory (BAI) & Beck Depression Inventory (BDI) were administered to individuals with
chronic low back pain. |
0 week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [seemasaini80@gmail.com].
- For how long will this data be available start date provided 30-03-2025 and end date provided 15-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The Turkish Adaptation, Validity, and Reliability Study of the Cognitive Behavior Questionnaire (CBQ) in Non-Specific Chronic Low Back Pain focuses on the adaptation of the CBQ into the Turkish language and cultural context. This research evaluates the psychometric properties of the CBQ, including its validity (how well the questionnaire measures cognitive-behavioral aspects in this population) and reliability (the consistency of its results over time and across different groups). The study is essential for understanding cognitive and behavioral patterns associated with chronic low back pain among Turkish speakers, aiding in tailored interventions and enhancing patient outcomes. |