Spinal Cord InjuriesNCT05059405
Pashto Translation of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale
An observational study of Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.
Trial summary
There is a need for a culturally adapted screening tool to aid health care professionals or clinicians screen for the presence of neuropathic pain associated with spinal cord injuries in Pashtoon population. . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 113 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Jun 2021to 3 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: spinal cord injury patients
Who may be able to join
- Patients with traumatic spinal cord injury
- Both Complete and Incomplete SCI patients
- Patients having pain history after spinal cord injury
- Patients having 3 or more than 3 months duration of SCI
- SCI at or below thoracic spine
Who cannot join
- Patients with other neurological disorders like multiple sclerosis, GBS, etc.
- Congenital conditions, tumor etc.
- Diabetic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pashto Translation, Validity and Reliability of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale in Spinal Cord Injuries
There is a need for a culturally adapted screening tool to aid health care professionals or clinicians screen for the presence of neuropathic pain associated with spinal cord injuries in Pashtoon population. . Since Paraplegic center Hayatabad Peshawar is a reputable institute for spinal cord injury patients' rehabilitation in Khyber pakhtun khwa where most of Pashto speaking SCI patients are rehabilitated. While working there as a physical therapist I, my other colleagues and patients felt a need for a screening tool for pain in Pashto language .So I decided to a conduct a tool validation study. This study will help the clinicians to assess their patient's pain type easily through the Pashto version of LANSS pain scale in Pashtoon population and hence will help in timely management of the pain.
Read the detailed description
The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, a screening questionnaire for identifying patients with neuropathic pain, was developed to identify patients with neuropathic mechanisms dominating their pain experience. The original English version of the LANSS pain scale has been translated and validated in Turkish, Spanish, Swedish, Brazilian, Portuguese, and Chinese Mandarin languages. However, no neuropathic pain questionnaire including the LANSS has yet been established in Pasto language in Pakistan.
Although these screening tools are based on descriptors, their linguistic adaptation and validation into different languages are feasible and this ensures their reliability and validity in languages other than those in which they were initially developed.
- Conditions
- Spinal Cord Injuries
- Keywords
- Pain
- Medical subject headings
- Spinal Cord Injuries, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pashto version of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
Pashto version of the LANSS will be developed through our study which will be same in contents to English version and will be applied on the spinal cord injury patients for validity and reliability in Pashtoon population.
Measured: 1 week
Douleur Neuropathique 4 Questions (DN4) questionnaire
The DN4 questionnaire consists of a total of 10 items grouped in 4 sections . The first seven items are related to the quality of pain (burning, painful cold, electric shocks) and its association to abnormal sensations (tingling, pins and needles, numbness, itching). The other 3 items are related to neurological examination in the painful area (touch hypoesthesia, pinprick hypoesthesia, tactile allodynia). A score of 1 is given to each positive item and a score of 0 to each negative item. The total score is calculated as the sum of all 10 items, and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start26 Jun 2021
- Primary completion31 Jan 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT(NMR), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059405
- Sponsor's protocol ID
- REC01035 Habib Khan
- Status last verified
- Apr 2022
- First submitted
- 17 Sep 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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
- Pashto Translation, Validity and Reliability of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale in Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT05059405
- Acronym / sponsor ID
- REC01035 Habib Khan
- Conditions
- Spinal Cord Injuries
- Keywords
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 28 Sep 2021 (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.
There is a need for a culturally adapted screening tool to aid health care professionals or clinicians screen for the presence of neuropathic pain associated with spinal cord injuries in Pashtoon population. . Since Paraplegic center Hayatabad Peshawar is a reputable institute for spinal cord injury patients' rehabilitation in Khyber pakhtun khwa where most of Pashto speaking SCI patients are rehabilitated. While working there as a physical therapist I, my other colleagues and patients felt a need for a screening tool for pain in Pashto language .So I decided to a conduct a tool validation study. This study will help the clinicians to assess their patient's pain type easily through the Pashto version of LANSS pain scale in Pashtoon population and hence will help in timely management of the pain.
Detailed description
The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, a screening questionnaire for identifying patients with neuropathic pain, was developed to identify patients with neuropathic mechanisms dominating their pain experience. The original English version of the LANSS pain scale has been translated and validated in Turkish, Spanish, Swedish, Brazilian, Portuguese, and Chinese Mandarin languages. However, no neuropathic pain questionnaire including the LANSS has yet been established in Pasto language in Pakistan.
Although these screening tools are based on descriptors, their linguistic adaptation and validation into different languages are feasible and this ensures their reliability and validity in languages other than those in which they were initially developed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- spinal cord injury patients
Key inclusion criteria (5 listed)
- Patients with traumatic spinal cord injury
- Both Complete and Incomplete SCI patients
- Patients having pain history after spinal cord injury
- Patients having 3 or more than 3 months duration of SCI
- SCI at or below thoracic spine
Key exclusion criteria (3 listed)
- Patients with other neurological disorders like multiple sclerosis, GBS, etc.
- Congenital conditions, tumor etc.
- Diabetic patients.
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
Pashto version of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
Time frame: 1 week
Pashto version of the LANSS will be developed through our study which will be same in contents to English version and will be applied on the spinal cord injury patients for validity and reliability in Pashtoon population.
Douleur Neuropathique 4 Questions (DN4) questionnaire
Time frame: 1 week
The DN4 questionnaire consists of a total of 10 items grouped in 4 sections . The first seven items are related to the quality of pain (burning, painful cold, electric shocks) and its association to abnormal sensations (tingling, pins and needles, numbness, itching). The other 3 items are related to neurological examination in the painful area (touch hypoesthesia, pinprick hypoesthesia, tactile allodynia). A score of 1 is given to each positive item and a score of 0 to each negative item. The total score is calculated as the sum of all 10 items, and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
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
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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.
Mirza Obaid Baig, MSPT(NMR) principal investigator
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 Cord Injuries, 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 5 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?
Pashto version of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale (time frame: 1 week). The study lists 2 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.