AzTrials
AzTrials

Neck PainNCT04843241

Translation of Neck Disability Index Into Local Pakistani Languages of Pakistan

An observational study of Neck Pain, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The aim of the study is to translate the neck disability index (NDI) questionnaire into Pushto, Punjabi, Sindhi and Balochi versions and o test the validity \& reliability of translated versions of NDI among neck pain patients in Pakistan. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Neck Pain
How many people
500 participants
Where
1 sitePakistan
Study dates
1 Apr 2021to 30 Dec 2021
Phase
Observational
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 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: To meet inclusion criteria participants diagnosed with neck pain, clinically stable, and able to read the local language version of NDI. Then patient response will be checked on the translated version

Who may be able to join

  • Mechanical neck pain
  • Participants belonging to Urdu, Pushto, Punjabi, Sindhi and Balochi speaking class
  • Participants from inpatient and outpatient department of hospitals
  • participants should complete the questionnaire in their respective language without the help

Who cannot join

  • Healthy Individuals
  • Pathological neck pain
  • Traumatic cervical or neck injuries
  • Participants with disability due to any structural/ congenital cause

Trial locations and contacts

1 site in 1 country.

Imran Amjad, PhD contact

03324390125

imran.amjad@riphah.edu.pk

Syed Hashir Ali, MSPT(SPT) contact

Pakistan1 site, 1 recruiting

  • Margalla Rehabilitation Center

    Rawalpindi, Punjab Province

    Nazim Farooq, Phd, 03004269864, nazimfarooq@yahoo.com

    Syed Hashir Ali, MS

    Recruiting

Other trials in Pakistan

About this study

Official title: Test of Reliability and Validation of Neck Disability Index Questionnaire in Local Languages of Pakistan

The aim of the study is to translate the neck disability index (NDI) questionnaire into Pushto, Punjabi, Sindhi and Balochi versions and o test the validity \& reliability of translated versions of NDI among neck pain patients in Pakistan.

Read the detailed description

The Neck Disability Index is a state-unambiguous instrument for the description of a disability. It is revised from the Oswestry Low Back Pain Questionnaire It contains 10 items mentioning various activities (personal care, lifting, driving, work, sleeping, concentration, reading, recreation) and pain (pain intensity, headache) with 6 conceivable answers for each item. Patients are educated to choose only one answer which most closely suits their condition at the current time. The score of each item ranges between 0 (no pain and no functional limitation) and 5 (worst pain and maximal limitation) that lead to the total score of 0 (no disability) to 50 (totally disabled), as 0-4 points (no disability), 5-14 points (10-28% disability), 15-24 points (30-48% disability), 25-34 points (50-64% disability) and 35-50 points (70-100% disability). The meantime to fill the questionnaire is 3-7.8 minutes. The NDI showed high validity and reliability for patients with neck pain.

By this study, the accuracy and reproducibility of the translated versions of NDI questionnaires will be enhanced and thus can create a useful measure to obtain data from culturally/linguistically diverse people belonging to different ethnic background as in Pakistan. It will create trustworthiness among clinicians and researchers to utilize the tool as a measure of what it is supposed to measure.

Conditions
Neck Pain
Keywords
Neck Pain, Neck Disability Index, Tool Translation
Medical subject headings
Neck Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Translation of the Neck Disability Index questionnaire into Pushto, Punjabi, Sindhi and Balochi versions

    The Neck Disability Index is a state-unambiguous instrument for the description of a disability. It is revised from the Oswestry Low Back Pain Questionnaire It contains 10 items mentioning various activities (personal care, lifting, driving, work, sleeping, concentration, reading, recreation) and pain (pain intensity, headache) with 6 conceivable answers for each item, so translation for this NDI is to be done into regional languages of Pakistan through a rigorous and approved process. The minimum and maximum possible scores could be 0 and 50. The higher the score more the disability is there.

    Measured: 6 months

Secondary outcomes (1)

  1. Test the validity & reliability of translated versions of Neck Disability Index among neck pain patients in Pakistan

    To determine reliability and validity of cross-culturally adapted and the translated NDI versions in patients with neck pain of respective languages۔ Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two or more interval between different visits of the patient and validity is how accurate the results are. Thus these both are to measured through various parameters to validate the translated versions as appropriate and applicable.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2021
  2. Study start1 Apr 2021
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion30 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04843241
Sponsor's protocol ID
REC/00934 Syed Hashir Ali
Status last verified
Apr 2021
First submitted
8 Apr 2021
Last updated
19 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rathore FA, Attique R, Asmaa Y. Prevalence and Perceptions of Musculoskeletal Disorders Among Hospital Nurses in Pakistan: A Cross-sectional Survey. Cureus. 2017 Jan 26;9(1):e1001. doi: 10.7759/cureus.1001.

    PubMed 28280654

  • Andersson HI, Ejlertsson G, Leden I, Rosenberg C. Chronic pain in a geographically defined general population: studies of differences in age, gender, social class, and pain localization. Clin J Pain. 1993 Sep;9(3):174-82. doi: 10.1097/00002508-199309000-00004.

    PubMed 8219517

  • Howell ER. The association between neck pain, the Neck Disability Index and cervical ranges of motion: a narrative review. J Can Chiropr Assoc. 2011 Sep;55(3):211-21.

    PubMed 21886283

  • Farooq MN, Mohseni-Bandpei MA, Gilani SA, Hafeez A. Urdu version of the neck disability index: a reliability and validity study. BMC Musculoskelet Disord. 2017 Apr 8;18(1):149. doi: 10.1186/s12891-017-1469-5.

    PubMed 28388888

Questions about this trial

What is this clinical trial studying?

An observational study of Neck Pain, run by Riphah International University at 1 site in Pakistan.

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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. 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 Pakistan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Translation of the Neck Disability Index questionnaire into Pushto, Punjabi, Sindhi and Balochi versions (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04843241, which also lists 4 linked publications.

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 19 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in