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

Sponsor
Cairo University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04136964
Collaborator
(none)
120
Enrollment
1
Location
28.4
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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?

Condition or Disease Intervention/Treatment Phase
  • Other: Neck COMI

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 Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Cross-cultural Adaptation and Validation of Arabic Version of the Core Outcome Measure Index (COMI) in Patients With Chronic Neck Pain
Actual Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Mar 15, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concurrent validity [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)

    Secondary Outcome Measures

    1. Test-retest reliability [5-14 days]

      This will be examined by comparing the results between the Arabic COMI questionnaires filled in the two testing sessions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo university Outpatient clinics Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Aliaa Rehan Youssef, Assistant professor of Orthopedic Physical Therapy, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04136964
    Other Study ID Numbers:
    • SYahya
    First Posted:
    Oct 23, 2019
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aliaa Rehan Youssef, Assistant professor of Orthopedic Physical Therapy, Cairo University
    Neck pain
    COMI
    Quality of life
    Questionnaire
    Validity
    Reliability
    Patient-reported outcome measures
    Additional relevant MeSH terms:
    Neck Pain

    Study Results

    No Results Posted as of Jul 28, 2021