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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202506664204956 Date of Registration: 04/06/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the Effect of Therapeutic Education on Lower Limb Pain and Low Back Pain in Moroccan Pilgrims : Randomized Clinical Trial
Official scientific title Evaluation of the Effect of Therapeutic Education on Lower Limb Pain and Low Back Pain in Moroccan Pilgrims : Randomized Clinical Trial
Brief summary describing the background and objectives of the trial The Hajj pilgrimage involves intense physical effort, often under harsh environmental conditions. Such exertion frequently leads to lower limb and back pain, including tendinitis, musculoskeletal disorders, and circulatory issues. This study aims to assess whether therapeutic education can reduce these types of pain among Muslim pilgrims traveling to Mecca. This randomized controlled clinical trial aims to evaluate the effect of a therapeutic education program on musculoskeletal pain—specifically lower limb pain and low back pain—among Moroccan pilgrims preparing for Hajj 2025. Hajj involves prolonged physical exertion under extreme environmental conditions, often exacerbating or triggering musculoskeletal discomfort, especially in older adults. Therapeutic education (TE) offers a non-pharmacological approach to help patients manage pain, reduce inappropriate medication use, and improve functional capacity. This study will assess whether a structured TE program—delivered before departure and supported via audiovisual materials and mobile messaging—can improve pain levels, decrease analgesic intake, and enhance quality of life among participants. Primary outcomes will focus on changes in global pain intensity (measured via visual analog scale) before and after Hajj. Secondary outcomes include analgesic use, specific joint pain, and quality of life assessed using the EQ-5D-5L questionnaire.
Type of trial CCT
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 Education /Training
Anticipated trial start date 20/05/2025
Actual trial start date
Anticipated date of last follow up 20/05/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 218
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
PACTR
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Therapeutic Education Program One group session lasting 1 hour, in groups of 10 participants. Additional components include: • Daily home-based physical preparation exercises, guided by audiovisual materials • Regular reminders and educational messages sent via WhatsApp group, up to the departure and throughout the Hajj period The intervention spans approximately 4 to 6 weeks, starting before departure and continuing until the end of the Hajj rites. The intervention consists of a structured Therapeutic Education Program for Pilgrims (TEPP) designed to prevent and manage musculoskeletal pain during Hajj. It includes: • A one-hour in-person educational session (groups of 10), delivered before departure, covering: Practical advice on pain prevention and joint protection Fall prevention strategies Equipment recommendations (e.g., appropriate footwear, walking aids, medical kits) • A home-based physical preparation program, with tailored exercises presented through audiovisual materials • An audiovisual module focusing on techniques to prevent muscular fatigue during Hajj • A WhatsApp group used to: Send regular reminders and motivational messages Reinforce educational content and encourage adherence to the program The intervention aims to improve physical readiness, reduce pain, decrease medication use, and enhance overall quality of life during and after the pilgrim 108
Control Group Usual Care No Specific Intervention. Participants in the control group will receive usual care only, with no scheduled sessions or specific therapeutic intervention provided during the study period. Usual Care No Specific Intervention. 108 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged between 50 and 75 years. Registered to participate in the Hajj 2025 pilgrimage. Provided written informed consent prior to enrollment. Presence of an active inflammatory joint disease. Lower limb prosthesis. Medical contraindication to prolonged walking Cognitive or psychiatric disorder that may interfere with participation or adherence to the study protocol. Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 75 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 12/03/2025 Ethics Committee for Biomedical Research Mohammed V University Faculty of Medicine and Pharmacy of Rabat Faculty of Dental Medicine of Rabat
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine and Pharmacy of Rabat RABAT 10000 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in the average global pain in the lower limbs and lumbar spine, measured using the Visual Analog Scale (VAS). One week before departure for Hajj , 48 hours after the end of the Hajj rites and one week after the end of Hajj rites.
Secondary Outcome Use of analgesics (frequency and type) during the pilgrimage. One week before departure for Hajj , and one week after the end of Hajj rites.
Secondary Outcome Quality of life, assessed by the EQ-5D-5L questionnaire One week before departure for Hajj , and one week after the end of Hajj rites.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Ayachi Hospital Route de la plage SALE 11150 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
AMRAR Route de la plage SALE 11150 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AMRAR Route de la plage SALE 11150 Morocco Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator YASSER BOUCHOUATA Bouchouata.yasser@gmail.com +212637051288 Al Ayachi Hospital
City Postal code Country Position/Affiliation
SALE 11150 Morocco Department of Rheumatology B Al Ayachi Hospital
Role Name Email Phone Street address
Public Enquiries LATIFA TAHIRI latifatahiri@yahoo.fr +212661425506 Route de la plage
City Postal code Country Position/Affiliation
SALE 11150 Morocco Department of Rheumatology B Al Ayachi Hospital
Role Name Email Phone Street address
Scientific Enquiries FADOUA ALLALI fadouaallali@yahoo.fr +212661181824 Route de la plage
City Postal code Country Position/Affiliation
SALE 11150 Morocco Department of Rheumatology B Al Ayachi Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No data sharing is planned; individual participant data (IPD) will remain confidential and inaccessible to external researchers or organisations. Study Protocol No data sharing is planned; individual participant data (IPD) will remain confidential and inaccessible to external researchers or organisations. No data sharing is planned; individual participant data (IPD) will remain confidential and inaccessible to external researchers or organisations.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 29/05/2025 I’ve included a brief background section for your study. This randomized controlled clinical trial aims to evaluate the effect of a therapeutic education program on musculoskeletal pain—specifically lower limb pain and low back pain—among Moroccan pilgrims preparing for Hajj 2025. Hajj involves prolonged physical exertion under extreme environmental conditions, often exacerbating or triggering musculoskeletal discomfort, especially in older adults. Therapeutic education (TE) offers a non-pharmacological approach to help patients manage pain, reduce inappropriate medication use, and improve functional capacity. This study will assess whether a structured TE program—delivered before departure and supported via audiovisual materials and mobile messaging—can improve pain levels, decrease analgesic intake, and enhance quality of life among participants. Primary outcomes will focus on changes in global pain intensity (measured via visual analog scale) before and after Hajj. Secondary outcomes include analgesic use, specific joint pain, and quality of life assessed using the EQ-5D-5L questionnaire. The Hajj pilgrimage involves intense physical effort, often under harsh environmental conditions. Such exertion frequently leads to lower limb and back pain, including tendinitis, musculoskeletal disorders, and circulatory issues. This study aims to assess whether therapeutic education can reduce these types of pain among Muslim pilgrims traveling to Mecca. This randomized controlled clinical trial aims to evaluate the effect of a therapeutic education program on musculoskeletal pain—specifically lower limb pain and low back pain—among Moroccan pilgrims preparing for Hajj 2025. Hajj involves prolonged physical exertion under extreme environmental conditions, often exacerbating or triggering musculoskeletal discomfort, especially in older adults. Therapeutic education (TE) offers a non-pharmacological approach to help patients manage pain, reduce inappropriate medication use, and improve functional capacity. This study will assess whether a structured TE program—delivered before departure and supported via audiovisual materials and mobile messaging—can improve pain levels, decrease analgesic intake, and enhance quality of life among participants. Primary outcomes will focus on changes in global pain intensity (measured via visual analog scale) before and after Hajj. Secondary outcomes include analgesic use, specific joint pain, and quality of life assessed using the EQ-5D-5L questionnaire.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 29/05/2025 No data sharing is planned; individual participant data (IPD) will remain confidential and inaccessible to external researchers or organisations. Demographic data (age, gender). Group allocation (intervention or control). Pain scores (VAS) at all time points. Use of analgesics (type and frequency). Quality of life scores (EQ-5D-5L). No data sharing is planned; individual participant data (IPD) will remain confidential and inaccessible to external researchers or organisations.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 23/05/2025 the informed consent obtained from participants does not explicitly include permission for secondary data sharing with external researchers or organizations. Individual Participant Data (IPD) will be made available 6 months after the final results are published. The data will remain accessible for a period of 5 years, upon reasonable request, for academic and non-commercial purposes, and only after approval by the ethics committee and the principal investigator. There is no plan to share the individual participant data (IPD) from this study.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 29/05/2025 No data sharing is planned; individual participant data (IPD) will remain confidential and inaccessible to external researchers or organisations. There is no plan to share the individual participant data (IPD) from this study. No data sharing is planned; individual participant data (IPD) will remain confidential and inaccessible to external researchers or organisations.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 23/05/2025 the informed consent obtained from participants does not explicitly include permission for secondary data sharing with external researchers or organizations. A written request outlining the purpose and scope of the data use. Use for academic and non-commercial research only. Approval by the principal investigator. Approval by the Ethics Committee for Biomedical Research – Mohammed V University. A signed data-sharing agreement ensuring confidentiality and appropriate data use. There is no plan to share the individual participant data (IPD) from this study.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 29/05/2025 No data sharing is planned; individual participant data (IPD) will remain confidential and inaccessible to external researchers or organisations. There is no plan to share the individual participant data (IPD) from this study. No data sharing is planned; individual participant data (IPD) will remain confidential and inaccessible to external researchers or organisations.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 29/05/2025 No data sharing is planned; individual participant data (IPD) will remain confidential and inaccessible to external researchers or organisations. Study Protocol, Statistical Analysis Plan, Informed Consent Form Study Protocol