Low Back PainNCT03328806
Cross Culture Adaptation and Validation of the Arabic Version of COMI in Patients With Low Back Pain
An observational study of Low Back Pain, run by Aliaa Rehan Youssef at 1 site in Egypt.
Trial summary
This study aims at translating, cross culturally adapting and establishing the psychometric properties of the The Core Outcome Measure Index (COMI) for patients with low back pain (LBP) in Egypt. This study will be conducted at the outpatient clinic of public hospitals in Egypt. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Low Back Pain
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Aug 2019
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study will be delimited to: 1-140 Egyptian patients diagnosed clinically with LBP with or without leg pain. 2- Patients' age ranging from 21 years to 50
Who may be able to join
- Adults male and females with age ranging from 21 to 50 years.
- Referred with a diagnosis of low back pain described as pain and discomfort, localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain (Airaksinen et al., 2006).
- Arabic speaking in the Egyptian dialect.
Who cannot join
- Back pain secondary to known specific pathology (e.g. infection, tumor, Osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis), radicular syndrome or cauda equine syndrome) (Mannion et al., 2012).
- Pregnant women
- Post-operative patients
- Patients who had traumatic injury in the lower quadrant within the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross Culture Adaptation and Validation of the Arabic Version of the Core Outcome Measure Index in Patients With Low Back Pain
This study aims at translating, cross culturally adapting and establishing the psychometric properties of the The Core Outcome Measure Index (COMI) for patients with low back pain (LBP) in Egypt. This study will be conducted at the outpatient clinic of public hospitals in Egypt.
This study will be divided into two main stages: (1) Translation and cross culture adaptation, and (2) Validation.
Read more
In the translation and cross culture adaptation stage, the original English version will be translated into modern Arabic following the guidelines described by Beaton et al. (2000). Then, the translated final version will be tested on a sample of 30-40 participants in a small pilot study to ensure linguistic clarity.
For the validation stage, 100 male and female adults with LBP will be recruited from public physiotherapy outpatient clinics. Eligible patients will be asked to complete a questionnaire booklet containing The Arabic versions of Oswestry Disability index (ODI), Ronald Morris Disability Questionnaire (RMDQ), Short-form 36 (SF-36) and the Visual analogy scale (VAS).
Further, disability and function will be assessed by Timed Up and Go test (TUG), 50 feet walking and loaded reach test.
Outcome measures will include:
- Face validity which will be evaluated subjectively based on judgment of expert committee and patients' feedback.
- Concurrent validity is assessed by testing correlation between the COMI and VAS, ODI, RMDQ and SF-36
- Construct validity will be assessed by testing the correlation between the scores for each item of the COMI and its corresponding valid back specific full-length questionnaire including the ODI, RMDQ, SF-36 and VAS.
All testing procedure will be repeated after seven days for testing reliability.
Read the detailed description
PROCEDURE:
(1) Translation and cross culture adaptation:
The cross-cultural adaptation process for the COMI will be done as described by (Beaton et al., 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. Both translators will be arabic native speakers.
- 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 by two independent native english translators. It is preferred that both translator do not have any information regarding the concept being tested nor have a medical background. The two translations will be compared and a Consensus will be developed.
- Expert committee that at least consists of a research methodologists, a health professionals, language professionals, and the translators (forward and back translators). The committee will compare between versions of the translated and original COMI and consolidate the pre-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 (30-40 individual) 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. The sample will fulfill the study inclusion and exclusion criteria of the proposed LBP sample that will be recruited for the validation and reliability testing. Patients will be asked to complete the pre-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.
- Submission of documentation to the developers or coordinating committee for appraisal of the adaptation process, IN this stage all reports will be submitted at the end of the translation process to explain details of the development of each. (2) Validation and reliability testing:
One hundred male and female adults will be recruited from public physiotherapy outpatient clinics. This sample size has been recommended as an appropriate size for reliability and validity analyses (Terwee et al., 2007). Patients will be eligible to participate in this study based on study inclusion and exclusion criteria.
Testing procedure:
First, eligible patients will have the purpose of the study and the procedures fully explained. Then, patients will be asked to participate in the study. If they accepted, an informed consent form will be signed.
Validation:
- Concurrent validity: Eligible patients will be asked to complete a questionnaire booklet containing The Arabic versions of ODI, RMDQ, SF-36 and VAS.
- Content validity:
Disability and function will be assessed by TUG, 50 feet walking and loaded reach test (Bennell, et al., 2011). All tests will be demonstrated to the patient in details before asking them to take the test as follow:
Timed Up and Go test (TUG):
First, a 3-meter distance will be marked on the floor. An armchair will be placed at one end of this distance. This test will be performed by measuring the time (in seconds) required by the patients to stand from sitting position and walk at his/her normal pace then turn back to the starting position(Bohannon, 2006; Herman and Hausdorff, 2011).
50-feet walk test: The patient will walk 25 foot forward then return back to the starting position as fast as s/he could. The time spent in this task will be measured in seconds using a stopwatch (Simmonds et al., 1998)
- Conditions
- Low Back Pain
- Keywords
- low back pain, outcome measures, cross culture adaptation, Core Outcome Measure Index
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the COMI and Ronald Morris Disability Questionnaire (RMDQ)
This will be done to assess the construct validity. RMDQ evaluates the disability associated with LBP. It consists of 24 yes/no items related specifically to physical functions including walking, bending over, sitting, lying down, dressing sleeping, self-care and daily activities. Patients are asked whether the statements apply to them that day (i.e. the last 24 h). One point is given for each item. The total score ranges from 0 (no disability) to 24 (severe disability).
Measured: 1 day
Secondary outcomes (6)
Correlation between the COMI and Visual Analogue Scale (VAS)
To assess concurrent validity. The VAS is a valid and reliable scale to assess pain. It ranges from 0 (no pain) to 10 (severe excruciating pain). Pain will be given a line measuring 10 com, with 0 and 10 marked on opposite ends. Then, patient will be asked to put a mark on that line to indicate the level of pain experienced.
Measured: 1 day
Correlation between the COMI and Oswestry Disability Index (ODI)
To assess concurrent validity. ODI is a self-reported questionnaire consisting of questions arranged in 10 domains. Each domain contains six questions that are scored ranging from 0 (minimum degree of difficulty in that activity) to 5 (maximum degree of difficulty). These questions assess the activities of daily living in patients with LBP, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. If more than one statement is marked in each section, the highest score should be taken. The total score is 50 which expressed as a percentage.
Measured: 1 day
Correlation between the COMI and Short Form 36 (SF-36)
To assess concurrent validity. SF-36 is a short-form questionnaire for measuring health surveys (physical, role, and social functioning, mental health, and general health perceptions) and two concepts were added by empirical work (bodily pain and vitality).
Measured: 1 day
Perceived changes in back and/or leg pain
Patients will be asked to report any change in current back or leg pain at the time of second testing using a 5-point Likert scale (a little bit better, better, no chance, a little bit worse, worse)
Measured: 1 day
Reliability of COMI
Patients will be asked to complete COMI after seven to 14 days days to test its reliability by comparing between the results at the first and second time to detect any discrepancies.
Measured: 7-14 days
Face validity
The face validity is dependent on judgment of expert committee and patients' feedback.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Jul 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aliaa Rehan Youssef
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aliaa Rehan Youssef, Cairo University
- Investigators
- Aliaa Rehan Youssef, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328806
- Sponsor's protocol ID
- Ay7au712017
- Status last verified
- Oct 2019
- First submitted
- 24 Sep 2017
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Disoky S, El-Ghoul Y, Heissam K, & Mohamed R. Prevalence of Low Back Pain and its Effect on Quality of Life among Patients Attending Abokhalefa Center, Ismailia Governorate. Med. J. Cairo Univ, 83(1), 385-394, 2015.
Duthey B. Background paper 6.24 low back pain. World Health Organisation (WHO)(ed.) Priority medicines for Europe and the world 'A public health approach to innovation'. Geneva: WHO. 2013 Mar 15.
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 11128900Nakhostin Ansari N, Naghdi S, Eskandari Z, Salsabili N, Kordi R, Hasson S. Reliability and validity of the Persian adaptation of the Core Outcome Measure Index in patients with chronic low back pain. J Orthop Sci. 2016 Nov;21(6):723-726. doi: 10.1016/j.jos.2016.07.022. Epub 2016 Aug 18.
PubMed 27545452Atlas SJ, Deyo RA. Evaluating and managing acute low back pain in the primary care setting. J Gen Intern Med. 2001 Feb;16(2):120-31. doi: 10.1111/j.1525-1497.2001.91141.x.
PubMed 11251764Azimi, P. Comparing COMI and RMDQ-24, NCOS, ODI, JOA and SSS Questionnaires in Patients with Lumbar Spinal Stenosis. WSCJ, 3: 87-90, 2012
Beaton 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 11124735Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70. doi: 10.1002/acr.20538. No abstract available.
PubMed 22588756Beurskens AJ, de Vet HC, Koke AJ, van der Heijden GJ, Knipschild PG. Measuring the functional status of patients with low back pain. Assessment of the quality of four disease-specific questionnaires. Spine (Phila Pa 1976). 1995 May 1;20(9):1017-28. doi: 10.1097/00007632-199505000-00008.
PubMed 7631231Bohannon RW. Reference values for the timed up and go test: a descriptive meta-analysis. J Geriatr Phys Ther. 2006;29(2):64-8. doi: 10.1519/00139143-200608000-00004.
PubMed 16914068Chou YC, Shih CC, Lin JG, Chen TL, Liao CC. Low back pain associated with sociodemographic factors, lifestyle and osteoporosis: a population-based study. J Rehabil Med. 2013 Jan;45(1):76-80. doi: 10.2340/16501977-1070.
PubMed 23052969Costa LO, Maher CG, Latimer J. Self-report outcome measures for low back pain: searching for international cross-cultural adaptations. Spine (Phila Pa 1976). 2007 Apr 20;32(9):1028-37. doi: 10.1097/01.brs.0000261024.27926.0f.
PubMed 17450079Damasceno LH, Rocha PA, Barbosa ES, Barros CA, Canto FT, Defino HL, Mannion AF. Cross-cultural adaptation and assessment of the reliability and validity of the Core Outcome Measures Index (COMI) for the Brazilian-Portuguese language. Eur Spine J. 2012 Jul;21(7):1273-82. doi: 10.1007/s00586-011-2100-3. Epub 2011 Dec 15.
PubMed 22170447Deyo 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 9779535Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
PubMed 9820257
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Culture Adaptation and Validation of the Arabic Version of the Core Outcome Measure Index in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT03328806
- Acronym / sponsor ID
- Ay7au712017
- Conditions
- Low Back Pain
- Keywords
- low back pain, outcome measures, cross culture adaptation, Core Outcome Measure Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Aliaa Rehan YoussefUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 1 Nov 2017 (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.
This study aims at translating, cross culturally adapting and establishing the psychometric properties of the The Core Outcome Measure Index (COMI) for patients with low back pain (LBP) in Egypt. This study will be conducted at the outpatient clinic of public hospitals in Egypt.
This study will be divided into two main stages: (1) Translation and cross culture adaptation, and (2) Validation.
In the translation and cross culture adaptation stage, the original English version will be translated into modern Arabic following the guidelines described by Beaton et al. (2000). Then, the translated final version will be tested on a sample of 30-40 participants in a small pilot study to ensure linguistic clarity.
For the validation stage, 100 male and female adults with LBP will be recruited from public physiotherapy outpatient clinics. Eligible patients will be asked to complete a questionnaire booklet containing The Arabic versions of Oswestry Disability index (ODI), Ronald Morris Disability Questionnaire (RMDQ), Short-form 36 (SF-36) and the Visual analogy scale (VAS).
Further, disability and function will be assessed by Timed Up and Go test (TUG), 50 feet walking and loaded reach test.
Outcome measures will include:
- Face validity which will be evaluated subjectively based on judgment of expert committee and patients' feedback.
- Concurrent validity is assessed by testing correlation between the COMI and VAS, ODI, RMDQ and SF-36
- Construct validity will be assessed by testing the correlation between the scores for each item of the COMI and its corresponding valid back specific full-length questionnaire including the ODI, RMDQ, SF-36 and VAS.
All testing procedure will be repeated after seven days for testing reliability.
Detailed description
PROCEDURE:
(1) Translation and cross culture adaptation:
The cross-cultural adaptation process for the COMI will be done as described by (Beaton et al., 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. Both translators will be arabic native speakers.
- 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 by two independent native english translators. It is preferred that both translator do not have any information regarding the concept being tested nor have a medical background. The two translations will be compared and a Consensus will be developed.
- Expert committee that at least consists of a research methodologists, a health professionals, language professionals, and the translators (forward and back translators). The committee will compare between versions of the translated and original COMI and consolidate the pre-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 (30-40 individual) 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. The sample will fulfill the study inclusion and exclusion criteria of the proposed LBP sample that will be recruited for the validation and reliability testing. Patients will be asked to complete the pre-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.
- Submission of documentation to the developers or coordinating committee for appraisal of the adaptation process, IN this stage all reports will be submitted at the end of the translation process to explain details of the development of each. (2) Validation and reliability testing:
One hundred male and female adults will be recruited from public physiotherapy outpatient clinics. This sample size has been recommended as an appropriate size for reliability and validity analyses (Terwee et al., 2007). Patients will be eligible to participate in this study based on study inclusion and exclusion criteria.
Testing procedure:
First, eligible patients will have the purpose of the study and the procedures fully explained. Then, patients will be asked to participate in the study. If they accepted, an informed consent form will be signed.
Validation:
- Concurrent validity: Eligible patients will be asked to complete a questionnaire booklet containing The Arabic versions of ODI, RMDQ, SF-36 and VAS.
- Content validity:
Disability and function will be assessed by TUG, 50 feet walking and loaded reach test (Bennell, et al., 2011). All tests will be demonstrated to the patient in details before asking them to take the test as follow:
Timed Up and Go test (TUG):
First, a 3-meter distance will be marked on the floor. An armchair will be placed at one end of this distance. This test will be performed by measuring the time (in seconds) required by the patients to stand from sitting position and walk at his/her normal pace then turn back to the starting position(Bohannon, 2006; Herman and Hausdorff, 2011).
50-feet walk test: The patient will walk 25 foot forward then return back to the starting position as fast as s/he could. The time spent in this task will be measured in seconds using a stopwatch (Simmonds et al., 1998)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will be delimited to: 1-140 Egyptian patients diagnosed clinically with LBP with or without leg pain. 2- Patients' age ranging from 21 years to 50
Key inclusion criteria (3 listed)
- Adults male and females with age ranging from 21 to 50 years.
- Referred with a diagnosis of low back pain described as pain and discomfort, localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain (Airaksinen et al., 2006).
- Arabic speaking in the Egyptian dialect.
Key exclusion criteria (4 listed)
- Back pain secondary to known specific pathology (e.g. infection, tumor, Osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis), radicular syndrome or cauda equine syndrome) (Mannion et al., 2012).
- Pregnant women
- Post-operative patients
- Patients who had traumatic injury in the lower quadrant within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between the COMI and Ronald Morris Disability Questionnaire (RMDQ)
Time frame: 1 day
This will be done to assess the construct validity. RMDQ evaluates the disability associated with LBP. It consists of 24 yes/no items related specifically to physical functions including walking, bending over, sitting, lying down, dressing sleeping, self-care and daily activities. Patients are asked whether the statements apply to them that day (i.e. the last 24 h). One point is given for each item. The total score ranges from 0 (no disability) to 24 (severe disability).
6 secondary outcomes
Correlation between the COMI and Visual Analogue Scale (VAS)
Time frame: 1 day
Correlation between the COMI and Oswestry Disability Index (ODI)
Time frame: 1 day
Correlation between the COMI and Short Form 36 (SF-36)
Time frame: 1 day
Perceived changes in back and/or leg pain
Time frame: 1 day
Reliability of COMI
Time frame: 7-14 days
Face validity
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- BackgroundAl-Disoky S, El-Ghoul Y, Heissam K, & Mohamed R. Prevalence of Low Back Pain and its Effect on Quality of Life among Patients Attending Abokhalefa Center, Ismailia Governorate. Med. J. Cairo Univ, 83(1), 385-394, 2015.
- BackgroundDuthey B. Background paper 6.24 low back pain. World Health Organisation (WHO)(ed.) Priority medicines for Europe and the world 'A public health approach to innovation'. Geneva: WHO. 2013 Mar 15.
- 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 27545452Nakhostin Ansari N, Naghdi S, Eskandari Z, Salsabili N, Kordi R, Hasson S. Reliability and validity of the Persian adaptation of the Core Outcome Measure Index in patients with chronic low back pain. J Orthop Sci. 2016 Nov;21(6):723-726. doi: 10.1016/j.jos.2016.07.022. Epub 2016 Aug 18.
- Background: PubMed 11251764Atlas SJ, Deyo RA. Evaluating and managing acute low back pain in the primary care setting. J Gen Intern Med. 2001 Feb;16(2):120-31. doi: 10.1111/j.1525-1497.2001.91141.x.
- BackgroundAzimi, P. Comparing COMI and RMDQ-24, NCOS, ODI, JOA and SSS Questionnaires in Patients with Lumbar Spinal Stenosis. WSCJ, 3: 87-90, 2012
- 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 22588756Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70. doi: 10.1002/acr.20538. No abstract available.
- Background: PubMed 7631231Beurskens AJ, de Vet HC, Koke AJ, van der Heijden GJ, Knipschild PG. Measuring the functional status of patients with low back pain. Assessment of the quality of four disease-specific questionnaires. Spine (Phila Pa 1976). 1995 May 1;20(9):1017-28. doi: 10.1097/00007632-199505000-00008.
- Background: PubMed 16914068Bohannon RW. Reference values for the timed up and go test: a descriptive meta-analysis. J Geriatr Phys Ther. 2006;29(2):64-8. doi: 10.1519/00139143-200608000-00004.
- Background: PubMed 23052969Chou YC, Shih CC, Lin JG, Chen TL, Liao CC. Low back pain associated with sociodemographic factors, lifestyle and osteoporosis: a population-based study. J Rehabil Med. 2013 Jan;45(1):76-80. doi: 10.2340/16501977-1070.
- Background: PubMed 17450079Costa LO, Maher CG, Latimer J. Self-report outcome measures for low back pain: searching for international cross-cultural adaptations. Spine (Phila Pa 1976). 2007 Apr 20;32(9):1028-37. doi: 10.1097/01.brs.0000261024.27926.0f.
- 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 Rehan 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 Low Back Pain, run by Aliaa Rehan Youssef 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between the COMI and Ronald Morris Disability Questionnaire (RMDQ) (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 NCT03328806, which also lists 48 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 15 Oct 2019.