Spinal DeformityNCT05239962
A Reliability And Validity Study Of The Urdu Version Of Spine Functional Index.
An observational study of Spinal Deformity, run by Riphah International University at 1 site in Pakistan.
Trial summary
The Aim of the study is to translate Spine Functional Index scale into Urdu Language and to investigate the validity and reliability in Pakistan with the populace of Spinal disorders. Also checks its co-relation with Neck disability Index and Roland-Morris Disability Questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Deformity
- How many people
- 220 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 5 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be of Spinal cord disorders like. Lumbar or thoracic or Cervical or Multiple Areas pain
Who may be able to join
- The criteria for participation in this study were at least 18 years of age.
- The patient must be diagnosed with musculoskeletal disorder of the spine.
- The patient can be chronic and sub-acute and acute.
- The patient can be referred by a physician or physical therapist.
Who cannot join
- Lack of reading Urdu or reply to the survey questions were the criteria for exclusion.
- Infectious diseases and patient without spinal disorders were excluded.
- The patients with late surgery or systemic sickness which effects spine was excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Evaluation of Reliability and Validity of Urdu Version of Spine Functional Index
The Aim of the study is to translate Spine Functional Index scale into Urdu Language and to investigate the validity and reliability in Pakistan with the populace of Spinal disorders. Also checks its co-relation with Neck disability Index and Roland-Morris Disability Questionnaire.
Read the detailed description
As per the previous recommendations, the Spine Functional Index will be interpreted in urdu language and adapted culturally. Participants will be selected by the convenience sampling technique based on pre-defined inclusion and exclusion criteria from a total of 220 participants with spinal Disorders. To test the reliability of Urdu Version Of Spine Functional Index, Neck Disability Index and Roland-Morris Disability Questionnaire in the inter and intra-observer environment, two observers and an interim interval of 45 minutes between the first and second application fill out a questionnaire on the same day for the inter-observer assessment. Observer-1 for the intra-observer evaluation will conduct a third evaluation after 7 days. Using Statistical Package of Social Sciences version 24, data is entered and analyzed. Cronbach Alpha Value is used to analyze center consistency. The intraclass correlation coefficient is used to assess the reliability of the test-retest. For content validity, criteria validity and responsiveness, the Urdu Version Of Spine Functional Index was assessed.
- Conditions
- Spinal Deformity
- Keywords
- Spine Functional Index, Spinal Disorders, Cultural adaptation, Validity, Urdu Version, Reliability
What is being measured
The primary outcome is the main question the study is designed to answer.
Spine Functional Index
Spine Functional Index is a single page of 25 items with a three-point respond option. The score of 25 items is summed and this score is then multiplied by four and deducted from 100 (0 % score = max disability or functional loss and 100 % score = no impairments or normal).
Measured: 1st day
Roland-Morris Questionnaire
Roland-Morris Questionnaire is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.
Measured: 1st day
Neck Disability Index
Neck Disability Index contains total 50 scores. 5 marks for each statement. If the response is missing then the score will not be conducted or included in total marks.
Measured: 1st day
Oswestry Low Back Pain Index
Oswestry Low Back Pain Index is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start30 May 2021
- Primary completion1 Mar 2022
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239962
- Sponsor's protocol ID
- REC/FSD/0289
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reliability and Validity of Urdu Version of Spine Functional Index
- ClinicalTrials.gov ID
- NCT05239962
- Acronym / sponsor ID
- REC/FSD/0289
- Conditions
- Spinal Deformity
- Keywords
- Spine Functional Index, Spinal Disorders, Cultural adaptation, Validity, Urdu Version, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 15 Feb 2022 (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 Aim of the study is to translate Spine Functional Index scale into Urdu Language and to investigate the validity and reliability in Pakistan with the populace of Spinal disorders. Also checks its co-relation with Neck disability Index and Roland-Morris Disability Questionnaire.
Detailed description
As per the previous recommendations, the Spine Functional Index will be interpreted in urdu language and adapted culturally. Participants will be selected by the convenience sampling technique based on pre-defined inclusion and exclusion criteria from a total of 220 participants with spinal Disorders. To test the reliability of Urdu Version Of Spine Functional Index, Neck Disability Index and Roland-Morris Disability Questionnaire in the inter and intra-observer environment, two observers and an interim interval of 45 minutes between the first and second application fill out a questionnaire on the same day for the inter-observer assessment. Observer-1 for the intra-observer evaluation will conduct a third evaluation after 7 days. Using Statistical Package of Social Sciences version 24, data is entered and analyzed. Cronbach Alpha Value is used to analyze center consistency. The intraclass correlation coefficient is used to assess the reliability of the test-retest. For content validity, criteria validity and responsiveness, the Urdu Version Of Spine Functional Index was assessed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be of Spinal cord disorders like. Lumbar or thoracic or Cervical or Multiple Areas pain
Key inclusion criteria (4 listed)
- The criteria for participation in this study were at least 18 years of age.
- The patient must be diagnosed with musculoskeletal disorder of the spine.
- The patient can be chronic and sub-acute and acute.
- The patient can be referred by a physician or physical therapist.
Key exclusion criteria (3 listed)
- Lack of reading Urdu or reply to the survey questions were the criteria for exclusion.
- Infectious diseases and patient without spinal disorders were excluded.
- The patients with late surgery or systemic sickness which effects spine was excluded
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
Spine Functional Index
Time frame: 1st day
Spine Functional Index is a single page of 25 items with a three-point respond option. The score of 25 items is summed and this score is then multiplied by four and deducted from 100 (0 % score = max disability or functional loss and 100 % score = no impairments or normal).
Roland-Morris Questionnaire
Time frame: 1st day
Roland-Morris Questionnaire is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.
Neck Disability Index
Time frame: 1st day
Neck Disability Index contains total 50 scores. 5 marks for each statement. If the response is missing then the score will not be conducted or included in total marks.
Oswestry Low Back Pain Index
Time frame: 1st day
Oswestry Low Back Pain Index is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
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 5 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Spinal Deformity
Not yet recruitingEarly Phase 1
SPX-01 Gene Therapy in Pediatric Patients With Spinal Muscular Atrophy Type 1 (RISE)
Spinal Muscular Atrophy (SMA)
Active, not recruitingObservational study
Natural History of Spinocerebellar Ataxia Type 7 (SCA7)
Spinocerebellar Ataxia
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
Colon Cancer
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.
Muhammad Kashif study chair
Riphah International 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 Spinal Deformity, run by Riphah International University at 1 site in Pakistan.
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 3 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 5 Apr 2022. 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 Pakistan. 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?
Spine Functional Index (time frame: 1st day). The study lists 4 primary outcomes in all. 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 5 Apr 2022.