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.: PACTR201511000689333 Date of Approval: 28/10/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title An investigation into the prevalence of MSC and the effectiveness of an intervention program for these patients
Official scientific title An investigation into the prevalence and nature of musculoskeletal conditions amongst women attending Primary Health Care Clinics, and the effectiveness of an intervention program for these patients
Brief summary describing the background and objectives of the trial Musculoskeletal diseases are one of the main causes of disability and is let down by a considerable lack of epidemiological data across a range of geography and treatments. To explore the effectivenss of a non-pharmacological 6 weeks intervention program for MSD and either/or hypertension, obesity or diabetes mellitus type II.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal diseases, hypertension, obesity and diabetes mellitus type II
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2015
Actual trial start date 01/04/2015
Anticipated date of last follow up 20/05/2015
Actual Last follow-up date 20/05/2015
Anticipated target sample size (number of participants) 74
Actual target sample size (number of participants) 74
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known HREC Ref: 605/2013
nil known HREC Ref: 605/2013
nil known HREC Ref: 605/2013
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 Stratified according to three BMI levels and randomisation will be done for each group separately using the Microsoft Excell random function Microsoft Excell random function Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified according to three BMI levels and randomisation will be done for each group separately using the Microsoft Excell random function Microsoft Excell random function Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified according to three BMI levels and randomisation will be done for each group separately using the Microsoft Excell random function Microsoft Excell random function Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 6 weeks non-pharmacological intervention program 2 hours once a week 6 weeks Introduction session and baseline measurements, workbook, pedometers and exercises sessions under the guidance of a physiotherapist or physiotherapy student 37
Control Group 6 weeks non-pharmacological intervention program 2 baseline measurements and introduction session Twice in six weeks more or less 60 minutes Introduction, workbook and pedometer 37
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women between the ages of 40-64 years who tested positive on screening for joint pain, diabetes mellitus type II, hypertension and obesity during the survey. Minimum literacy required for the study will be Grade 4 to be able to understand and complete the workbook. All nine Primary Health Care clinics in Blomefontein and MUCPP participants will be eligble for inclusion. Participants must indicate their willigness to participate in the study. Participants must be contactable telephonically. Participants must understand English and/or Sesotho and must be willing to commit to the physiotherapy exercise program for 2 hours once a week for six weeks. Women who present with other chronic diseases including cancer, cardio-vascular diseases (coronary heart disease), stroke, depression and chronic respiratory diseases. Women screening positive for joint pain, diabetes mellitus type II, hypertension and obesity but who present with an increase risk for participating in exercise. This will be determined by screening and a physical examination by a qualified medical practitioner. Women with neurological disorders or who are wheelchair bound who are unlikely to be able to participate in the planned intervention. 40 Year(s) 64 Year(s) Female
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 02/10/2013 Human Research Ethics Committee University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Drive Cape Town 7925 South Africa
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 26/06/2014 UFS Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 339 Bloemfontein 9300 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine the effectiveness of a non-pharmacological intervention in reducing joint pain severtiy in 6 weeks Baseline After 6 weeks
Secondary Outcome Determine the efficacy of an introduction and workbook against structured classes and education sessions utilizing the same workbook Baseline After 6 weeks
Secondary Outcome Determine the contribution a non-pharmacological intervention will have on decreasing joint pain as measured by the Brief Pain Inventory (Short form) Baseline After 6 weeks
Secondary Outcome Determine if the implementation of an appropriate intervention program will improve the health related quality of life in women with joint pain, diabetes mellitus type II, hypertension and obesity as measured by teh EQ-5D Baseline After 6 weeks
Secondary Outcome Determine if the implementation of an appropriate intervention program will improve the functional impact joint pain has on the individual and co-morbidies as measured by the WHODASII and the Simmonds battery of functional tests; 6 mint walk test Baseline After 6 weeks
Secondary Outcome Determine the interrelationship between joint pain and co-morbidities of individuals as measured by blood pressure, body mass index, venous glucose readings, cholesterol readings and cardiovascular fitness using the 3 minute step test Baseline After 6 weeks
Secondary Outcome To determine whether self-efficacy will result in a greater compliance with medication Baseline After 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MUCPP Moshoeshoe Road Bloemfontein South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Directorate, University of the Free State Rectors Avenue Bloemfontein 9301 South Africa
National Research Foundation
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Directorate, University of the Free State Rectors Avenue Bloemfontein 9301 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Kobus Marais Rectors Avenue Bloemfontein 9301 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roline Barnes BarnesRY@ufs.ac.za +27514013295 Rectors Avenue
City Postal code Country Position/Affiliation
Bloemfontein 9301 South Africa Lecturer
Role Name Email Phone Street address
Public Enquiries Roline Barnes BarnesRY@ufs.ac.za +27514013295 Rectors Avenue
City Postal code Country Position/Affiliation
Bloemfontein 9301 Spain Lecturer
Role Name Email Phone Street address
Scientific Enquiries Roline Barnes BarnesRY@ufs.ac.za +27514013295 Rectors Avenue
City Postal code Country Position/Affiliation
Bloemfontein 9301 South Africa Lecturer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information