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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
RESEARCH QUESTION:
Will the Arabic version of neck-COMI be a valid and reliable tool to assess neck pain in the Egyptian patients?
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:
(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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neck COMI | Other | Patients will be asked to fill a questionnaire booklet consisting of five patient-reported outcome measures twice within 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concurrent validity | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Test-retest reliability | This will be examined by comparing the results between the Arabic COMI questionnaires filled in the two testing sessions. | 5-14 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be selected from orthopedic and Physical therapy outpatient clinics
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| Name | Affiliation | Role |
|---|---|---|
| Aliaa Regan Youssef, PhD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university Outpatient clinics | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11128900 | Background | Andresen EM. Criteria for assessing the tools of disability outcomes research. Arch Phys Med Rehabil. 2000 Dec;81(12 Suppl 2):S15-20. doi: 10.1053/apmr.2000.20619. | |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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