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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05059405
Other study ID # REC01035 Habib Khan
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 26, 2021
Est. completion date March 3, 2022

Study information

Verified date April 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. . 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date March 3, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients with other neurological disorders like multiple sclerosis, GBS, etc. - Congenital conditions, tumor etc. - Diabetic patients.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Paraplegic Center Peshawar KPK

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 week
Primary 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. 1 week
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