| CTRI Number |
CTRI/2024/06/068628 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Translation and Validation in Hindi language, social adaptation of Neuropathic pain Questionnaire |
|
Scientific Title of Study
|
Hindi Translation, Validation and Test- Retest Reliability of Neuropathic Pain Questionnaire(NPQ) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashica sharma |
| Designation |
PG student (MPT) |
| Affiliation |
Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana |
| Address |
General outpatient department (OPD), Room no 4, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9818085108 |
| Fax |
|
| Email |
yashicasharma1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
MMIPR |
| Address |
Room No 1, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Yashica sharma |
| Designation |
PG student (MPT) |
| Affiliation |
MMIPR |
| Address |
General outpatient department (OPD), Room no 1, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
09818085108 |
| Fax |
|
| Email |
yashicasharma1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markendeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markendeshwar Deemed to be University, Mullana, Ambala, Haryana, Pin Code- 133207 |
|
|
Primary Sponsor
|
| Name |
Yashica Sharma |
| Address |
Maharishi Markendeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markendeshwar Deemed to be University, Mullana, Ambala, Haryana, Pin Code- 133207 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sunita Sharma |
Maharishi Markendeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markendeshwar Deemed to be University, Mullana, Ambala, Haryana, Pin Code- 133207 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Yashica |
Maharishi Markandeshwar Super Speciality Hospital |
Room no.4, General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be-University), Mullana-Ambala, Haryana
Ambala
HARYANA |
9818085108
yashicasharma1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MMIMSR, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G60-G65||Polyneuropathies and other disorders of the peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neuropathic Pain |
Each patient will fill out the newly translated followed by an interview session, which will be helpful to find out if there is a lag in each item of the questionnaire by asking them certain questions like what they thought when attempting the particular item in the domain and thus the chosen response. The responses that will be obtained for each item in the questionnaire will be explored. This ensures that the acclimated interpretation retains its parity in a practical situation.
Duration- 10-15 minutes |
| Comparator Agent |
NILL |
NILL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Neuropathic chronic pain patients
2. Non- Neuropathic chronic pain patients
3. Other chronic pain patients
4. Both males and females |
|
| ExclusionCriteria |
| Details |
1. Acute pain
2. children
3. Non Hindi speaking population
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neuropathic Pain Questionnaire (NPQ) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
30/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 - NO
|
|
Brief Summary
|
The recognition that neuropathic pain syndromes were very common necessitated the development of pain scales specific to neuropathic pain. Recent studies have confirmed the existence of neuropathic pain components in patients with musculoskeletal disorders. English, Turkish, Urdu, Spanish, version of NPQ is available for assessment, but no Hindi version of NPQ is yet available for population who only communicates and understands Hindi language. It is necessary that the questionnaire is understood by the Indian population. In fact, a correct exposition of the items by patients is crucial to obtain correct feedback thus making the questionnaire valid to evaluate patient’s contentment and well being. The purpose of this study is to translate into the Hindi version of the NPQ and to evaluate its validity and reliability. A cross-sectional study. The study method includes the translation of the NPQ in Hindi language from English by 2 translators i.e.T1 and T2 from medical and non-medical background respectively. The recording observer then takes a seat to create a T12 version of the translated questionnaire. The reverse translation from the T12 form to the previous form is now being done. Then, an expert panel analyses all the stages and all of the questionnaire items that the translated form of the questionnaire is free of errors, allowing it to be field tested. Evaluation of content’s validity is done. The pre-final form is then fully tested on patients, and the scale’s validity is reported. Finally, the translated questionnaire version will be analyzed by the ethics committee. |