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.: PACTR201911553990405 Date of Approval: 05/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Manual therapy on pain, activity and quality of life in beninese hip osteoarthritis patients: a randomised controlled trial.
Official scientific title Effectiveness of Manual therapy on pain, activity and quality of life in beninese hip osteoarthritis patients: a randomised controlled trial.
Brief summary describing the background and objectives of the trial Osteoarthritis is a degenerative joint disease that modifies cartilage structure. Cartilage thickness is reduced and adjacent structures, i.e. synovial membrane, menisci and subjacent bones, are also affected. In time, osteoarthritis causes pain, decreased physical function and, finally, reduced quality of life. Total hip replacement is the most reported of the treatment options that are available. It is recognized as effective in pain relief, and relatively safe and cost-efficient in patients suffering from severe hip osteoarthritis. However, it is inaccessible for most patients in underdeveloped countries like Benin. A country characterized by a low health insurance policy and too expensive access to health care in general and arthroplasty. As a result, they face a long-term disability. Based on the literature, several authors have reported that, regardless of the important effects of hip replacement on pain and stiffness, patients' activities and quality of life have remained less than desired 6 months after surgery. To improve patient care, new approaches are developed in the recent years. One of these methods is called manual therapy. Many studies have shown its beneficial effect on pain, physical function and quality of life in certain Musculoskeletal disorders. But few have been performed on hip OA, following the International Classification of Functioning, Disability and Health (ICF) model. This project is initiated to study the effects of manual therapy on structures and functions, activity and quality of life in patients with hip osteoarthritis in Benin.
Type of trial RCT
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 Rehabilitation
Anticipated trial start date 06/11/2018
Actual trial start date
Anticipated date of last follow up 06/03/2020
Actual Last follow-up date 06/03/2020
Anticipated target sample size (number of participants) 58
Actual target sample size (number of participants) 66
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Self rehabilitation One session per day 30 minutes to one hour a day for 6 weeks A Series of exercises described and illustrated in a document. The purpose of these exercises is to prevent the hip from stiffening, to increase flexibility and to reinforce the muscles around the thigh. All exercises are repeated once or twice. 29 Active-Treatment of Control Group
Experimental Group Manual therapy Twice a week 1 session of one hour for six weeks The therapy is based on passive hip joint mobilization. The Maitland mobilisation method is the one applied in the intervention, specifically the mobilisation in flexion-adduction-internal rotation. For the clinical approach, we start with the flexion-adduction-internal rotation mobilisation in distraction if patient "irritable" then in neutral then in compression (slight... strong) if patient End Of Range. 29
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who have hip osteoarthritis as defined by standard antero posterior radiographs of pelvis using the Kellgren and Lawrence scale. - No hip arthroplasty on fracture, - Being able to walk on treadmill, - Associated neurological diseases, - Serious cardio-pulmonary history preventing walking, - Hip Replacement Revision, - Disorders of comprehension or inability to understand instructions and complete the assessments. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 80 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 17/10/2018 COMITE ETHIQUE DE LA RECHERCHE DE LA CLINIQUE UNIVERSITAIRE DE MEDECINE PHYSIQUE ET READAPTATION DU CNHU HKM
Ethics Committee Address
Street address City Postal code Country
Avenue Pape Jean-Paul II 01 BP 386 Cotonou 00229 Benin
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Numerical Pain Rating Scale and Oxford Hip Score to measure pain intensity Before intervention, end of intervention and 3 months follow-up
Secondary Outcome Kellgren and Lawrence radiographic classification to measure the severity of osteoarthritis Before intervention, end of intervention and 3 months follow-up
Secondary Outcome The classic goniometer to assess hip joint mobility. Before intervention, end of intervention and 3 months follow-up
Secondary Outcome The Medical Research Council scale to measure muscle strength. Before intervention, end of intervention and 3 months follow-up
Secondary Outcome The 10-meter walk test to measure spontaneous walking speed of the patient. Before intervention, end of intervention and 3 months follow-up
Secondary Outcome The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Short form 36 (SF 36) to assess patients' quality of life. Before intervention, end of intervention and 3 months follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre National Hospitalier et Universitaire Hubert Koutoukou Maga Avenue Pape Jean-Paul II 01 BP 386. Cotonou 00229 Benin
HIA du Camp Guezo Zongo Ehuzu BP 517 Cotonou 00229 Benin
HOPITAL DE ZONE DE SURULERE Rue 1305 Avotrou Cotonou 00229 Benin
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre National Hospitalier Universitaire Hubert K Maga Avenue Pape Jean Paul II Cotonou 00229 Benin Hospital
COLLABORATORS
Name Street address City Postal code Country
Detrembleur Christine Avenue Mounier 53 Bruxelles 1200 Belgium
Mahaudens Philippe Avenue Mounier 53 Bruxelles 1200 Belgium
Kpadonou Godonou Toussaint Avenue Jean Paul II Cotonou 00229 Benin
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator TODEGNON FRANCK ASSOGBA francky5583@yahoo.fr +22997033776 CARRE 192
City Postal code Country Position/Affiliation
Portonovo 00229 Benin PhD student UNIVERSITE CATHOLIQUE DE LOUVAIN
Role Name Email Phone Street address
Principal Investigator Christine Detrembleur christine.detrembleur@uclouvain.be +32497356901 Avenue Mounier 53
City Postal code Country Position/Affiliation
Bruxelles 1200 Belgium UNIVERSITE CATHOLIQUE DE LOUVAIN
Role Name Email Phone Street address
Principal Investigator Philippe Mahaudens philippe.mahaudens@uclouvain.be +32496022206 Avenue Mounier 53
City Postal code Country Position/Affiliation
Bruxelles 1200 Belgium UNIVERSITE CATHOLIQUE DE LOUVAIN
Role Name Email Phone Street address
Public Enquiries TODEGNON FRANCK ASSOGBA francky5583@yahoo.fr +22997033776 CARRE 192
City Postal code Country Position/Affiliation
Portonovo 00229 Benin PhD Student UNIVERSITE CATHOLIQUE DE LOUVAIN
Role Name Email Phone Street address
Scientific Enquiries Christine Detrembleur christine.detrembleur@uclouvain.be +32497356901 Avenue Mounier 53
City Postal code Country Position/Affiliation
Bruxelles 1200 Belgium UNIVERSITE CATHOLIQUE DE LOUVAIN
Role Name Email Phone Street address
Scientific Enquiries Philippe Mahaudens philippe.mahaudens@uclouvain.be +32496022206 Avenue Mounier 53
City Postal code Country Position/Affiliation
Bruxelles 1200 Belgium UNIVERSITE CATHOLIQUE DE LOUVAIN
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data described in the protocol Study Protocol After publication Co-authors' agreement
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