NCT05059405

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

September 17, 2021

Last Update Submit

April 2, 2022

Conditions

Keywords

Pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

spinal cord injury patients

You may qualify if:

  • 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

You may not qualify if:

  • Patients with other neurological disorders like multiple sclerosis, GBS, etc.
  • Congenital conditions, tumor etc.
  • Diabetic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paraplegic Center

Peshawar, KPK, Pakistan

Location

MeSH Terms

Conditions

Spinal Cord InjuriesPain

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mirza Obaid Baig, MSPT(NMR)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 28, 2021

Study Start

June 26, 2021

Primary Completion

January 31, 2022

Study Completion

March 3, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations