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

NCT04136964 | Unknown

• 1 other identifier: SYahya
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Neck Pain

Keywords

Neck pain; COMI; Quality of life; Questionnaire; Validity; Reliability; Patient-reported outcome measures

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Test-retest reliability

  5-14 days

Study Arms (1)

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

Interventions

Neck COMI OTHER

Patients will be asked to fill a questionnaire booklet consisting of five patient-reported outcome measures twice within 14 days.

Also known as: VAS, NDI, EQ-VAS, EQ-5D

Patients group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from orthopedic and Physical therapy outpatient clinics

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university Outpatient clinics

Cairo, Egypt

Location

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MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aliaa Regan Youssef, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Orthopedic Physical Therapy

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: November 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: March 15, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

EG (1)