Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401754503987 Date of Approval: 15/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Neuropathic Pain in Ankylosing Spondylitis: Association with Functional Status, Quality of Life, Sleep Quality, Disease Activity, and Depression Levels
Official scientific title Neuropathic pain in ankylosing spondylitis: Association with functional status, quality of life, sleep quality, disease activity and depression levels: A multi-center cross-sectional study
Brief summary describing the background and objectives of the trial Background: Ankylosing spondylitis (AS) is one of the most prevalent disorders in rheumatology. Functional capacities are impaired in AS, which lowers patients' quality of life and makes them feel invalidated. The primary symptom of AS is chronic pain, which can sometimes be caused by both the neuropathic and inflammatory components of pain; further research is necessary to fully understand this problem. Objectives: To assess neuropathic pain in patients with AS and its association with functional status, Quality of Life, Sleep Quality, Disease Activity, and Depression Levels
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/11/2023
Actual trial start date 01/03/2024
Anticipated date of last follow up 01/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Questionnaires Assessment 4 months • Neuropathic pain (NP) Will be assessed by the Leeds Neuropathic Pain Rating Scale (LANSS) and by the Douleur Neuropathique 4 (DN4). • Quality of life (QOL): Will be evaluated by the Evaluation of Ankylosing Spondylitis Quality of Life (EASi-QoL) questionnaire and by the Short-Form 36 (SF-36). • Disease activity: This will be evaluated by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP). • Functional Disability: Will be evaluated by the Bath AS Functional Index (BASFI), The Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ‑S), • Sleep quality: The Pittsburgh Sleep Quality Index (PSQI) will be used. • Depression: Will be measured by the Center for Epidemiologic Studies Depression Scale (CES-D) questionnaire 250
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Consecutive patients >18 years - Consecutive patients <65 years - Classified with Ankylosing Spondylitis according to the New York classification criteria - Patients agreed to participate in the study - Patients who were pregnant; - Patients with any rheumatological disease other than Ankylosing Spondylitis - Patients diagnosed with fibromyalgia or other systemic diseases affecting sleep quality Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/01/2024 Al Azhar University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Nasr City Cairo 11765 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Quality of life (QOL): was evaluated by Evaluation of Ankylosing Spondylitis Quality of Life (EASi-QoL) questionnaire, Short-Form 36 (SF-36) baseline
Primary Outcome • Fatigue: was measured by a visual analogic scale (VAS-F) baseline
Primary Outcome • Functional Disability: was evaluated by The Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ‑S), the Bath Ankylosing Functional Index (BASFI). baseline
Primary Outcome • Depression: was measured by the CES-D questionnaire baseline
Secondary Outcome • Disease activity: was evaluated by ASDAS-ESR, BASDAI baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rheumatology Department Al Azhar University Al Azhar University Square Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al Azhar University Al Azhar University Square Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Al Azhar University Nasr City Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wesam Gouda drwesamgouda@yahoo.com +201002753754 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Al Azhar University
Role Name Email Phone Street address
Scientific Enquiries Seham A. Elazab s.abdallah.azab@gmail.com +201000263048 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Al Azhar University
Role Name Email Phone Street address
Public Enquiries Wesam Gouda drwesamgouda@yahoo.com +201002753754 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Al Azhar University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data was collected during the trial after identification. Results will be published by the investigators in academic journals. The generated study data will be shared in several different ways. We plan to make our results available to researchers and potential collaborators interested in Ankylosing Spondylitis research.” Informed Consent Form,Study Protocol Time Frame: “Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.” Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information