Chronic Neck PainNCT04136964
Cross-cultural Adaptation and Validation of Arabic Version of COMI in Patients With Chronic Neck Pain
An observational study of Chronic Neck Pain, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Neck COMI
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients will be selected from orthopedic and Physical therapy outpatient clinics
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- The Arabic version of neck-COMI will be a valid tool for the assessment of neck pain in Egyptian patients.
- 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?
Read the 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:
- 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.
- Synthesis of the translations by comparing the two Arabic translations and combine them into one version.
- 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.
- 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.
- 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.
- Conditions
- Chronic Neck Pain
- Being tested
- Neck COMI
- Keywords
- Neck pain, COMI, Quality of life, Questionnaire, Validity, Reliability, Patient-reported outcome measures
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck COMIOther
Also called VAS, NDI, EQ-VAS, EQ-5D
Patients will be asked to fill a questionnaire booklet consisting of five patient-reported outcome measures twice within 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neck COMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 day
Secondary outcomes (1)
Test-retest reliability
This will be examined by comparing the results between the Arabic COMI questionnaires filled in the two testing sessions.
Measured: 5-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Nov 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Rehan Youssef, Cairo University
- Investigators
- Aliaa Regan Youssef, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136964
- Sponsor's protocol ID
- SYahya
- Status last verified
- Jul 2021
- First submitted
- 21 Oct 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11128900Ariens GA, van Mechelen W, Bongers PM, Bouter LM, van der Wal G. Psychosocial risk factors for neck pain: a systematic review. Am J Ind Med. 2001 Feb;39(2):180-93. doi: 10.1002/1097-0274(200102)39:23.0.co;2-#.
PubMed 11170160Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
PubMed 28666405Bongers PM, Ijmker S, van den Heuvel S, Blatter BM. Epidemiology of work related neck and upper limb problems: psychosocial and personal risk factors (part I) and effective interventions from a bio behavioural perspective (part II). J Occup Rehabil. 2006 Sep;16(3):279-302. doi: 10.1007/s10926-006-9044-1.
PubMed 16850279Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
PubMed 18467932Borghouts JAJ, Koes BW, Bouter LM. The clinical course and prognostic factors of non-specific neck pain: a systematic review. Pain. 1998 Jul;77(1):1-13. doi: 10.1016/S0304-3959(98)00058-X.
PubMed 9755013Cagnie B, Danneels L, Van Tiggelen D, De Loose V, Cambier D. Individual and work related risk factors for neck pain among office workers: a cross sectional study. Eur Spine J. 2007 May;16(5):679-86. doi: 10.1007/s00586-006-0269-7. Epub 2006 Dec 8.
PubMed 17160393Deyo RA, Battie M, Beurskens AJ, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, Von Korff M, Waddell G. Outcome measures for low back pain research. A proposal for standardized use. Spine (Phila Pa 1976). 1998 Sep 15;23(18):2003-13. doi: 10.1097/00007632-199809150-00018.
PubMed 9779535Drost, E. A. (2011). Validity and Reliability in Social Science Research. Education Research and Perspectives, 38(1), 105-123
Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
PubMed 15621359Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G. Internal and external validity of cluster randomised trials: systematic review of recent trials. BMJ. 2008 Apr 19;336(7649):876-80. doi: 10.1136/bmj.39517.495764.25. Epub 2008 Mar 25.
PubMed 18364360Fankhauser CD, Mutter U, Aghayev E, Mannion AF. Validity and responsiveness of the Core Outcome Measures Index (COMI) for the neck. Eur Spine J. 2012 Jan;21(1):101-14. doi: 10.1007/s00586-011-1921-4. Epub 2011 Aug 20.
PubMed 21858567Feise RJ, Michael Menke J. Functional rating index: a new valid and reliable instrument to measure the magnitude of clinical change in spinal conditions. Spine (Phila Pa 1976). 2001 Jan 1;26(1):78-86; discussion 87. doi: 10.1097/00007632-200101010-00015.
PubMed 11148650Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
PubMed 15999284
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Validation of Arabic Version of the Core Outcome Measure Index (COMI) in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04136964
- Acronym / sponsor ID
- SYahya
- Conditions
- Chronic Neck Pain
- Keywords
- Neck pain, COMI, Quality of life, Questionnaire, Validity, Reliability, Patient-reported outcome measures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- The Arabic version of neck-COMI will be a valid tool for the assessment of neck pain in Egyptian patients.
- 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:
- 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.
- Synthesis of the translations by comparing the two Arabic translations and combine them into one version.
- 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.
- 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.
- 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Other: Neck COMIPatients 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be selected from orthopedic and Physical therapy outpatient clinics
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck COMIAlso: VAS, NDI, EQ-VAS, EQ-5DPatients will be asked to fill a questionnaire booklet consisting of five patient-reported outcome measures twice within 14 days. | Other | Patients group |
Primary outcome
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 secondary outcome
Test-retest reliability
Time frame: 5-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Background: PubMed 11128900Andresen 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.
- Background: PubMed 11170160Ariens GA, van Mechelen W, Bongers PM, Bouter LM, van der Wal G. Psychosocial risk factors for neck pain: a systematic review. Am J Ind Med. 2001 Feb;39(2):180-93. doi: 10.1002/1097-0274(200102)39:23.0.co;2-#.
- Background: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- Background: PubMed 28666405Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
- Background: PubMed 16850279Bongers PM, Ijmker S, van den Heuvel S, Blatter BM. Epidemiology of work related neck and upper limb problems: psychosocial and personal risk factors (part I) and effective interventions from a bio behavioural perspective (part II). J Occup Rehabil. 2006 Sep;16(3):279-302. doi: 10.1007/s10926-006-9044-1.
- Background: PubMed 18467932Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
- Background: PubMed 9755013Borghouts JAJ, Koes BW, Bouter LM. The clinical course and prognostic factors of non-specific neck pain: a systematic review. Pain. 1998 Jul;77(1):1-13. doi: 10.1016/S0304-3959(98)00058-X.
- Background: PubMed 17160393Cagnie B, Danneels L, Van Tiggelen D, De Loose V, Cambier D. Individual and work related risk factors for neck pain among office workers: a cross sectional study. Eur Spine J. 2007 May;16(5):679-86. doi: 10.1007/s00586-006-0269-7. Epub 2006 Dec 8.
- Background: PubMed 9779535Deyo RA, Battie M, Beurskens AJ, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, Von Korff M, Waddell G. Outcome measures for low back pain research. A proposal for standardized use. Spine (Phila Pa 1976). 1998 Sep 15;23(18):2003-13. doi: 10.1097/00007632-199809150-00018.
- BackgroundDrost, E. A. (2011). Validity and Reliability in Social Science Research. Education Research and Perspectives, 38(1), 105-123
- Background: PubMed 15621359Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
- Background: PubMed 18364360Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G. Internal and external validity of cluster randomised trials: systematic review of recent trials. BMJ. 2008 Apr 19;336(7649):876-80. doi: 10.1136/bmj.39517.495764.25. Epub 2008 Mar 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliaa Regan Youssef, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Neck Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concurrent validity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04136964, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.