Cross-cultural Adaptation and Validation of Arabic Version of COMI in Patients With Chronic Neck Pain

July 27, 2021 updated by: Aliaa Rehan Youssef, Cairo University

Cross-cultural Adaptation and Validation of Arabic Version of the Core Outcome Measure Index (COMI) in Patients With Chronic Neck Pain

PURPOSE:

To translate, validate and examine the psychometric properties of the Arabic version of the COMI in Egyptian patients with neck pain.

BACKGROUND:

Neck pain is a highly prevalent musculoskeletal disorders in adults affecting from 45.5% to 48%. It may cause disability that interferes with the quality of life. It is usually treated conservatively. To evaluate treatment effectiveness, patients need close monitoring and follow-up.

Different assessment tools are recommended including patient reported outcome measures. One of the newly introduced outcome measure is The Neck Core Outcome Measure Index (COMI). It is characterized by being brief, simple, self-reported and easy to answer questionnaire. The SPINE TANGO, which is the spine organization In Europe, has recommended its use for all patients with spine disorders.

This questionnaire has been translated into different languages such as German, Polish and Italian but it has never been translated and validated in the Arabic language.

HYPOTHESES

  1. The Arabic version of neck-COMI will be a valid tool for the assessment of neck pain in Egyptian patients.
  2. The Arabic version of neck-COMI will be a reliable tool for the assessment of neck pain in Egyptian patients.

RESEARCH QUESTION:

Will the Arabic version of neck-COMI be a valid and reliable tool to assess neck pain in the Egyptian patients?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study is translating and cross culturally adapting the COMI outcome measure for patients with neck pain in Egypt. This study will be conducted at the outpatient clinic of Cairo University hospitals in Egypt.

Translation:

The cross-cultural adaptation process for the COMI will be done as described by Beaton and colleagues (2000). This will include the following phases:

  1. Initial translation that includes forward translation to translate the questionnaire from the English language to Arabic by two independent bilingual translators one of them is familiar with the concepts of the COMI and the other translator doesn't have medical background.
  2. Synthesis of the translations by comparing the two Arabic translations and combine them into one version.
  3. Back translation to translate the Arabic version to the English language again. This should be done by two independent translators both of them shouldn't have medical background, yet not familiar with the use of COMI then comparing between two backwards translations to determine any differences between them and the original one.
  4. Expert committee that consists of both translators, one of the back-translators, one bilingual clinician and one native English clinical research scientist to compare between versions of the COMI and consolidate the final version. The role of the expert committee to detect and correct any conceptual errors or inconsistencies, grammatical or other errors.
  5. Test of the pre-final version of the instrument in a small sample to assess its content and face validity according to patients' feedback and collect comments about wording and clarity of the translated version via semi-structured interview. This will be done in a sample of 20 patients who fulfill the study inclusion and exclusion criteria. Patients will be asked to complete the final Arabic version of COMI and will be asked to comment on any linguistic ambiguity. Finally, researcher will discuss received comments and a consensus will be done to adapt any necessary changes.

(2) Validation and reliability testing:

One hundred male and female adults will be recruited from physiotherapy and Orthopedic outpatient clinics.This sample size has been recommended as an appropriate size for reliability and validity analyses.

Validation testing:

COMI will be tested by comparing it with Visual Analogue scale (VAS), EuroQol-visual analogue scale (EQ-VAS), EuroQo-5D (EQ-5D), Neck disability index (NDI).

Reliability testing:

Each patient will be asked to complete the questionnaire booklet in two-separate sessions within 14 days.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo university Outpatient clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be selected from orthopedic and Physical therapy outpatient clinics

Description

Inclusion Criteria:

  1. Egyptian adult patients who are native Arabic speakers.
  2. Age ranges from 20 and 60 years.
  3. Referred with the diagnosis of chronic mechanical neck pain with and without arm pain.
  4. Pain duration is greater than 3 months.

Exclusion Criteria:

  1. Systemic diseases e.g. rheumatic diseases
  2. Specific etiology of neck pain like spinal stenosis or fracture.
  3. Previous surgery or trauma to the spine
  4. Upper quadrant dysfunction, rather than radiculopathy.
  5. Inability to read (illiterate)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients group
Patients who have pain located in the anatomical region of the neck for more than three months due to mechanical causes; with or without radiation to the head, trunk, and upper limbs. Posteriorly, pain may be present in the neck region from the superior nuchal line to the spine of the scapula and the side region down to the superior border of the clavicle and the suprasternal notch.
Other: Neck COMI
Patients will be asked to fill a questionnaire booklet consisting of five patient-reported outcome measures twice within 14 days.
Other Names:
  • VAS, NDI, EQ-VAS, EQ-5D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concurrent validity
Time Frame: 1 day
It will be established by correlating the COMI subsections to the relevant sections in the questionnaire booklet (that consists of the NDI, VAS, EQ-VAS, EQ-D5)
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test-retest reliability
Time Frame: 5-14 days
This will be examined by comparing the results between the Arabic COMI questionnaires filled in the two testing sessions.
5-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Aliaa Regan Youssef, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ANTICIPATED)

December 30, 2021

Study Completion (ANTICIPATED)

March 15, 2022

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 22, 2019

First Posted (ACTUAL)

October 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYahya

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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