Nonspecific Spinal Pain (Including Cervical, Thoracic, and Lumbar Spinal Pain)NCT07671196
Validity and Reliability of Arabic Version of Extended Aberdeen Spine Pain Scale
An observational study of Nonspecific Spinal Pain (Including Cervical, Thoracic, and Lumbar Spinal Pain), run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this observational study is to determine whether the Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS) is a valid and reliable tool for assessing spine-related pain and functional disability in Arabic-speaking adults with nonspecific spinal pain. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Nonspecific Spinal Pain (Including Cervical, Thoracic, and Lumbar Spinal Pain)
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 1 Apr 2026
- How long will I take part?
- 7 Days
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population will consist of Arabic-speaking adults aged 18 to 45 years diagnosed with nonspecific spinal pain involving the cervical, thoracic, and/or lumbar regions of the spine. Eligible participants will be recruited from outpatient physical therapy and musculoskeletal clinics. Participants must be able to read and understand Arabic and provide informed consent. Individuals with a history of spinal surgery, neurological deficits, serious spinal pathology (e.g., cancer or infection), cognitive impairment, or psychiatric conditions that may interfere with questionnaire completion will be excluded.
Who may be able to join
- Adults aged 18-45 years.
- Both sexes.
- Diagnosed with nonspecific spinal pain (cervical, thoracic, or lumbar).
- Arabic is a primary spoken and written language.
- Ability to provide informed consent.
- Their experiences aren't less than ten years or at least master's degree in physical therapy.
Show all 9Show fewer
- Major part of their work is with the Arabic population.
- They are fluent in Arabic and English language.
- Both genders were included.
Who cannot join
- History of spinal surgery.
- Neurological deficits or serious pathology (e.g., cancer, infection).
- Cognitive impairment or psychiatric conditions preventing questionnaire completion.
- Undergoing active treatment changes during test-retest interval.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to determine whether the Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS) is a valid and reliable tool for assessing spine-related pain and functional disability in Arabic-speaking adults with nonspecific spinal pain.
The main questions it aims to answer are:
Read more
- Is the Arabic version of the EASPS a valid instrument for evaluating spine-related pain and disability among Arabic-speaking patients?
- Is the Arabic version of the EASPS a reliable instrument with acceptable internal consistency and test-retest reliability?
Participants will:
- Complete the Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS).
- Complete the Arabic version of the Short Form-36 (SF-36) questionnaire to assess construct validity.
- Participate in the cultural adaptation and validation process of the Arabic EASPS.
- A subgroup of participants will complete the Arabic EASPS again after 7 days to assess test-retest reliability.
Read the detailed description
Spinal pain, including cervical, thoracic, and lumbar pain, is one of the most common musculoskeletal disorders worldwide and is associated with significant disability, reduced quality of life, and increased healthcare utilization. Accurate assessment of spinal pain and its impact on functional activities is essential for clinical decision-making, monitoring treatment outcomes, and conducting research. Patient-reported outcome measures provide a practical and efficient method for evaluating pain severity and disability; however, the availability of culturally adapted and validated assessment tools for Arabic-speaking populations remains limited.
The Extended Aberdeen Spine Pain Scale (EASPS) is a multidimensional self-administered questionnaire designed to assess pain intensity, functional limitations, and disability related to the cervical, thoracic, and lumbar regions of the spine. The instrument has demonstrated acceptable psychometric properties in its original English version and has been culturally adapted into other languages. However, an Arabic version has not yet been developed or validated.
The purpose of this prospective observational study is to translate, culturally adapt, and evaluate the validity and reliability of the Arabic version of the Extended Aberdeen Spine Pain Scale among Arabic-speaking adults with nonspecific spinal pain. The translation and cross-cultural adaptation process will follow internationally accepted guidelines and will include forward translation, reconciliation, backward translation, expert committee review, and cognitive debriefing with representatives of the target population.
A total of 300 Arabic-speaking adults aged 18 to 45 years with nonspecific cervical, thoracic, or lumbar spinal pain will be recruited. Participants will complete the Arabic version of the EASPS and the validated Arabic version of the Short Form-36 (SF-36) Health Survey. Construct validity will be assessed by examining the relationship between EASPS scores and SF-36 outcomes. Face and content validity will be evaluated by expert panels consisting of healthcare professionals and language specialists. Exploratory factor analysis will be conducted to investigate the underlying factor structure of the questionnaire.
Reliability testing will include assessment of internal consistency using Cronbach's alpha coefficient and test-retest reliability using intraclass correlation coefficients (ICC). A subgroup of participants will complete the Arabic EASPS for a second time after a seven-day interval, provided that no significant clinical changes occur during that period.
The findings of this study are expected to provide a culturally appropriate, valid, and reliable Arabic version of the Extended Aberdeen Spine Pain Scale, facilitating the assessment of spinal pain and disability in clinical practice and research settings across Arabic-speaking populations.
- Keywords
- Spinal Pain, Neck Pain, Low back Pain, Extended Aberdeen Spine Pain Scale, Arabic Version, Cross-Cultural Adaptation, Questionnaire Validation, Reliability, Patient-Reported Outcome Measures
- Medical subject headings
- Neck Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arabic-Speaking Adults with Nonspecific Spinal Pain | This cohort consists of Arabic-speaking adults aged 18 to 45 years diagnosed with nonspecific spinal pain affecting the cervical, thoracic, and/or lumbar regions of the spine. Participants will complete the Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS) and the Arabic version of the SF-36 questionnaire. A subgroup of participants will complete the Arabic EASPS again after 7 days to evaluate test-retest reliability as part of the psychometric validation process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arabic Version of the Extended Aberdeen Spine Pain Scale (EASPS)
The Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS) will be used to assess spine-related pain and disability. The questionnaire contains 30 items covering pain, physical impairment, and functional disability. Responses are summed and converted to a score ranging from 0 to 100, with higher scores indicating greater disability. The measure will be used to evaluate the validity and reliability of the Arabic version of the instrument.
Measured: Baseline and 7 Days
Secondary outcomes (1)
Arabic Version of the Short Form-36 Health Survey (SF-36)
The Arabic version of the SF-36 questionnaire will be administered to assess construct validity of the Arabic EASPS. The SF-36 evaluates health-related quality of life across physical and mental health domains. The SF-36 yields domain scores ranging from 0 to 100, with higher scores indicating better health status and functioning. Correlations between SF-36 scores and EASPS scores will be analyzed to determine construct validity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 Sep 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonspecific Spinal Pain (Including Cervical, Thoracic, and Lumbar Spinal Pain)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Salah Ismaiel Elballat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671196
- Sponsor's protocol ID
- P.T.REC/012/006036
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Arabic Version of Extended Aberdeen Spine Pain Scale
- ClinicalTrials.gov ID
- NCT07671196
- Acronym / sponsor ID
- P.T.REC/012/006036
- Keywords
- Spinal Pain, Neck Pain, Low back Pain, Extended Aberdeen Spine Pain Scale, Arabic Version, Cross-Cultural Adaptation, Questionnaire Validation, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 26 Jun 2026 (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.
The goal of this observational study is to determine whether the Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS) is a valid and reliable tool for assessing spine-related pain and functional disability in Arabic-speaking adults with nonspecific spinal pain.
The main questions it aims to answer are:
- Is the Arabic version of the EASPS a valid instrument for evaluating spine-related pain and disability among Arabic-speaking patients?
- Is the Arabic version of the EASPS a reliable instrument with acceptable internal consistency and test-retest reliability?
Participants will:
- Complete the Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS).
- Complete the Arabic version of the Short Form-36 (SF-36) questionnaire to assess construct validity.
- Participate in the cultural adaptation and validation process of the Arabic EASPS.
- A subgroup of participants will complete the Arabic EASPS again after 7 days to assess test-retest reliability.
Detailed description
Spinal pain, including cervical, thoracic, and lumbar pain, is one of the most common musculoskeletal disorders worldwide and is associated with significant disability, reduced quality of life, and increased healthcare utilization. Accurate assessment of spinal pain and its impact on functional activities is essential for clinical decision-making, monitoring treatment outcomes, and conducting research. Patient-reported outcome measures provide a practical and efficient method for evaluating pain severity and disability; however, the availability of culturally adapted and validated assessment tools for Arabic-speaking populations remains limited.
The Extended Aberdeen Spine Pain Scale (EASPS) is a multidimensional self-administered questionnaire designed to assess pain intensity, functional limitations, and disability related to the cervical, thoracic, and lumbar regions of the spine. The instrument has demonstrated acceptable psychometric properties in its original English version and has been culturally adapted into other languages. However, an Arabic version has not yet been developed or validated.
The purpose of this prospective observational study is to translate, culturally adapt, and evaluate the validity and reliability of the Arabic version of the Extended Aberdeen Spine Pain Scale among Arabic-speaking adults with nonspecific spinal pain. The translation and cross-cultural adaptation process will follow internationally accepted guidelines and will include forward translation, reconciliation, backward translation, expert committee review, and cognitive debriefing with representatives of the target population.
A total of 300 Arabic-speaking adults aged 18 to 45 years with nonspecific cervical, thoracic, or lumbar spinal pain will be recruited. Participants will complete the Arabic version of the EASPS and the validated Arabic version of the Short Form-36 (SF-36) Health Survey. Construct validity will be assessed by examining the relationship between EASPS scores and SF-36 outcomes. Face and content validity will be evaluated by expert panels consisting of healthcare professionals and language specialists. Exploratory factor analysis will be conducted to investigate the underlying factor structure of the questionnaire.
Reliability testing will include assessment of internal consistency using Cronbach's alpha coefficient and test-retest reliability using intraclass correlation coefficients (ICC). A subgroup of participants will complete the Arabic EASPS for a second time after a seven-day interval, provided that no significant clinical changes occur during that period.
The findings of this study are expected to provide a culturally appropriate, valid, and reliable Arabic version of the Extended Aberdeen Spine Pain Scale, facilitating the assessment of spinal pain and disability in clinical practice and research settings across Arabic-speaking populations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arabic-Speaking Adults with Nonspecific Spinal Pain | – | –This cohort consists of Arabic-speaking adults aged 18 to 45 years diagnosed with nonspecific spinal pain affecting the cervical, thoracic, and/or lumbar regions of the spine. Participants will complete the Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS) and the Arabic version of the SF-36 questionnaire. A subgroup of participants will complete the Arabic EASPS again after 7 days to evaluate test-retest reliability as part of the psychometric validation process. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of Arabic-speaking adults aged 18 to 45 years diagnosed with nonspecific spinal pain involving the cervical, thoracic, and/or lumbar regions of the spine. Eligible participants will be recruited from outpatient physical therapy and musculoskeletal clinics. Participants must be able to read and understand Arabic and provide informed consent. Individuals with a history of spinal surgery, neurological deficits, serious spinal pathology (e.g., cancer or infection), cognitive impairment, or psychiatric conditions that may interfere with questionnaire completion will be excluded.
Key inclusion criteria (9 listed)
- Adults aged 18-45 years.
- Both sexes.
- Diagnosed with nonspecific spinal pain (cervical, thoracic, or lumbar).
- Arabic is a primary spoken and written language.
- Ability to provide informed consent.
Key exclusion criteria (4 listed)
- History of spinal surgery.
- Neurological deficits or serious pathology (e.g., cancer, infection).
- Cognitive impairment or psychiatric conditions preventing questionnaire completion.
- Undergoing active treatment changes during test-retest interval.
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
Arabic Version of the Extended Aberdeen Spine Pain Scale (EASPS)
Time frame: Baseline and 7 Days
The Arabic version of the Extended Aberdeen Spine Pain Scale (EASPS) will be used to assess spine-related pain and disability. The questionnaire contains 30 items covering pain, physical impairment, and functional disability. Responses are summed and converted to a score ranging from 0 to 100, with higher scores indicating greater disability. The measure will be used to evaluate the validity and reliability of the Arabic version of the instrument.
1 secondary outcome
Arabic Version of the Short Form-36 Health Survey (SF-36)
Time frame: Baseline
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 1 Jul 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nonspecific Spinal Pain (Including Cervical, Thoracic, and Lumbar Spinal 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 9 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 1 Jul 2026. 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?
Arabic Version of the Extended Aberdeen Spine Pain Scale (EASPS) (time frame: Baseline and 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.