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.: PACTR201211000443397 Date of Approval:
Trial Status:
TRIAL DESCRIPTION
Public title The effects of supervised versus non-supervised pilates mat exercises on non-specific chronic lower back pain
Official scientific title The effects of supervised versus non-supervised pilates mat exercises on non-specific chronic lower back pain
Brief summary describing the background and objectives of the trial The aim of this study is to compare the effects of an eight-week supervised Pilates mat programme with those of a non-supervised home exercise programme with regard to pain, function, quality of life, adherence, and participant satisfaction with such exercise programmes in managing non-specific chronic lower back pain (NSCLBP). Outline of the study: Lower back pain (LBP) is a common musculoskeletal disorder in both developed and developing countries. Exercise is one of the few evidenced-based treatments recommended for non-specific CLBP (NSCLBP). NSCLBP is a subgroup of LBP, which is difficult for physiotherapists to manage effectively. Previous studies have examined various supervised and non-supervised exercise approaches in treating CLBP, but there is no conclusive evidence in favour of one type over another. Two popular and safe approaches are Pilates group exercises and home exercises, both of which include similar exercises; the difference is that the one is supervised. These exercise approaches have not thus far been compared to determine the effects on NSCLBP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,non-specific lower back pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/02/2013
Actual trial start date
Anticipated date of last follow up 15/01/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pilates Supervised mat exercises twice a week for 8 weeks hour sessions Supervised exercise group (SEG) 15
Control Group non-supervised pilates exercises 4 times a week half hour sessions Home exercise group (HEG) 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants will be eligible for the study if they are females between 20 and 55 years old, who have experienced LBP for longer than six weeks at the time of recruitment. Such pain must originate from the back, more specifically in an area bounded by the 12th thoracic vertebra and the 12th ribs superiorly, the gluteal folds inferiorly and the contours of the trunk laterally.51 Alternatively, it must be recurring LBP of sufficient intensity to restrict functional activity in some manner. Participants must obtain a score of ¿moderate¿ or ¿greater¿ on the questions relating to ¿usual activities¿ and ¿pain/discomfort¿ of the health related quality of life questionnaire (EQ-5D) adapted from Macedo¿s study. Alternatively, they must score 4 or more on the RMDQ at randomization. Back treatment with a therapist registered with the Health Professionals Council of South Africa (HPCSA) or the Allied Health Professionals Council of South Africa (AHPCSA), must have been completed two weeks prior to study inclusion. All participants will be screened to identify those who are unsuitable for exercise management of their LBP using a Back Screening Questionnaire and the Patient Activity Readiness Questionnaire (PAR-Q). If exercise management is unsuitable, the participant will be referred on to a medical practitioner/ therapist of their choice for further management. Participants will be excluded from the study if they present with one or more of the following: known or suspected serious spinal pathology; previous spinal surgery; signs and symptoms of a recent episode of acute disc pathology with or without leg pain; leg pain with evidence of nerve root compromise; rheumatic or metabolic disease; co-morbid health condition preventing active participation in an exercise programme; pregnancy; inability to understand spoken English; inability to commit to an eight-week intervention programme or previous participation in a Pilates programme or other regular therapeutic back exercise programme in the last three months. 20 Year(s) 55 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 Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room E52-54 Groote Schuur Hospital Old Main Building Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome function as measured by the Roland Morris Disability Questionnaire baseline 4 weeks 8 weeks 12 weeks
Secondary Outcome pain intensity as measured by the NRS in the Brief Pain Inventory Questionnaire Baseline 4 weeks 8 weeks 12 weeks
Secondary Outcome Fear Avoidance as measured by the fear avoidance beliefs questionnaire baseline 4 weeks 8 weeks 12 weeks
Secondary Outcome Confidence to perform certain tasks as measured by the pain self efficacy questionnaire basleine 4 weeks 8 weeks 12 weeks
Secondary Outcome Quality of life as measured by the EQ-5D health questionnaire baseline 4 weeks 8 weeks 12 weeks
Secondary Outcome patient satisfaction as measured by an adapted Austin Better Backs Questionnaire baseline 4 weeks 8 weeks 12 weeks
Secondary Outcome Rating of perceived effect baseline
Secondary Outcome Trunk flexion baseline 4 weeks 8 weeks 12 weeks
Secondary Outcome adherence 4 weeks 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Healthjunction 29 Derry Street Cape Town 8001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Healthjunction 29 Derry Street Cape Town 8001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cathy chambers Physio and Pilates 29 Derry Street Cape Town 8001 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Jennifer Jelsma Physiotherapy Dept Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Catherine Chemaly cathy@healthjunction.co.za 021 461 2159 29 1
City Postal code Country Position/Affiliation
Derry Street Vredehoek 8001 South Africa Physiotherapist
Role Name Email Phone Street address
Public Enquiries Catherine Chemaly cathy@healthjunction.co.za 021 461 2159 29 Derry Street Vredehoek
City Postal code Country Position/Affiliation
Cape Town 8001 South Africa Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Jennifer Jelsma jennifer.jelsma@uct.ac.za 021 4066401 Groote Schuur Hospital, Old Main Building
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Supervisor
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