Clinical trial NCT04136964: Cross-cultural Adaptation and Validation of Arabic Version of COMI in Patients With Chronic Neck Pain
Official title: Cross-cultural Adaptation and Validation of Arabic Version of the Core Outcome Measure Index (COMI) in Patients With Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Neck Pain
Keywords: Neck pain
COMI
Quality of life
Questionnaire
Validity
Reliability
Patient-reported outcome measures
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from orthopedic and Physical therapy outpatient clinics

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?

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Concurrent validity
timeFrame: 1 day
Secondary outcomes:
measure: Test-retest reliability
timeFrame: 5-14 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university Outpatient clinics
Study officials:
affiliation: Cairo University
name: Aliaa Regan Youssef, PhD
role: PRINCIPAL_INVESTIGATOR
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