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.: PACTR202405901603120 Date of Registration: 31/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Short-term effects of pain neuroscience education combined with a physiotherapy protocol on patients with chronic low back pain.
Official scientific title Short-term effects of pain neuroscience education combined with a physiotherapy protocol on patients with chronic low back pain : a single-blind randomised controlled trial
Brief summary describing the background and objectives of the trial Chronic low back pain is currently regarded as one of the most debilitating conditions. When it occurs, bodily sensitivity increases, thereby reducing overall physical activity. This state of inactivity and physical incapacity hampers patients' functional recovery, compounded by psychological distress such as anxiety and depression, which fosters fear of pain and movement. While most treatments primarily target the biomedical aspect of the pathology, pain neuroscience education aims to address the psychological dimension of chronic low back pain. Integrating this education into treatment enables a comprehensive biopsychosocial approach to managing low back pain. This study primarily emphasizes educating patients about the neuroscientific foundations of their chronic low back pain. Main Objective: The primary objective is to determine whether conventional physiotherapy treatment combined with Pain Neuroscience Education (PNE) in patients with chronic low back pain will reduce pain intensity compared to conventional physiotherapy treatment alone. Secondary Objective: The secondary objective is to determine whether conventional physiotherapy treatment combined with PNE will reduce functional disability, pain-related beliefs (kinesiophobia and pain catastrophizing), and improve the quality of life in patients with chronic low back pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/05/2024
Actual trial start date 05/05/2024
Anticipated date of last follow up 28/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pain neuroscience education combined with a conventional physiotherapy protocol 30 days Patients in the intervention group receive, in addition to conventional physiotherapy sessions ( Massage,thermotherapy, and lower back strengthening exercises, totaling 12 sessions over 4 weeks, 3 times per week), four (04) group sessions of pain neuroscience education, which will take place once a week for four (04) weeks, lasting 30 to 45 minutes each. A PowerPoint presentation (Microsoft Corp., Redmond, WA, USA) will be utilized to effectively convey concepts to the patients. 20
Control Group conventional physiotherapy protocol 30 days Patients in the control group receive only conventional physiotherapy sessions consisting of massage,thermotherapy, and lower back strengthening exercises, totaling 12 sessions over 4 weeks (three times per week) with a physiotherapist of their choice. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible, individuals must be aged 18 or older, present themselves to the rehabilitation service with chronic low back pain (defined as pain in the lumbar region that may radiate to the buttock or iliac crest) persisting for more than 3 months. The pain intensity, measured on a Numeric Rating Pain Scale (NRPS) ranging from 0 "no pain" to 10 "worst pain imaginable," must fall between 3 and 10, inclusive. Any patient diagnosed with symptomatic low back pain or already operated upon; Any systemic inflammatory disease other than low back pain; Any patient diagnosed with chronic low back pain refusing to participate in the study; Any patient presenting debilitating cognitive and/or speech disorders; Illiteracy and any patient who does not speak Arabic. Adult: 19 Year-44 Year,Aged: 65+ Year(s),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
No 05/05/2024 Ethics Committee for Biomedical Research Mohammed V University of Rabat.
Ethics Committee Address
Street address City Postal code Country
Imp. Souissi Rabat 10100 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Numeric Pain Rating Scale (NPRS) To measure pain intensity Baseline, and at 1 month .
Secondary Outcome Arabic version of the Oswestry Disability Index (ODI) Arabic version of the Pain Catastrophizing Scale (PCS) Arabic version of the Tampa Scale of Kinesiophobia (TSK) Arabic version of the SF-12 (Medical Outcome Study Short Form – 12) Baseline, and at 1 month .
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Ayachi Hospital Sidi Bouhaja Street Sale 11150 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
El Ayachi Hospital Sidi Bouhaja street Sale 11150 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Physical medicine and rehabilitation unit El Ayachi Hospital Sidi Bouhaja Steet Sale Morocco Hospital
COLLABORATORS
Name Street address City Postal code Country
Physical medicine and rehabilitation unit of El Ayachi Hospital Sidi Bouhaja Street Sale 11150 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali IKEN ali.iken@gmail.com +212672494840 328 hay nahda 2
City Postal code Country Position/Affiliation
Rabat 10210 Morocco Mohammed V University of Rabat
Role Name Email Phone Street address
Public Enquiries Samia KARKOURI s.karkouri@um5r.ac.ma +2120661400735 Sidi Bouhaja Street
City Postal code Country Position/Affiliation
Sale 11150 Morocco Mohammed V University of Rabat
Role Name Email Phone Street address
Scientific Enquiries Anas Messouber anas_messouber@um5.ac.ma +212622589343 22 Rue Zaouia Naciria
City Postal code Country Position/Affiliation
Rabat 10140 Morocco Mohammed V University of Rabat
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in pain neuroscience education. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 1 month after article publication and the data will be made accessible for up to 24 months Access to the IPD and documents may be granted to individuals or entities engaged in scientific or scholarly research. Interested researchers or organizations must formally submit a request to : ali_iken@um5.ac.ma
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