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.: PACTR201606001660285 Date of Approval: 05/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparison of a pedometer-based walking program versus physiotherapy for patients suffering from nociceptive or neuropathic chronic, recurrent low b
Official scientific title A comparison of a pedometer-based walking program versus physiotherapy for patients suffering from nociceptive or neuropathic chronic, recurrent low back pain in Johannesburg
Brief summary describing the background and objectives of the trial The study aims to investigate whether a walking program will aid standard physiotherapy treatment in patients diagnosed with chronic, recurrent lower back pain (CLBP). Internationally, CLBP is one of the most prevalent musculoskeletal problems for which patients seek treatment (Koes 2010). Pharmaceutical investigations match diagnosis specific treatments to pain phenotypes, however physiotherapy is less discerning. This study will compare usual care physiotherapy and walking for the treatment of different CLBP phenotypes. The primary outcome measure will be pain and function. This will be a 12 week randomised controlled trial, held in three private practice physiotherapy clinics in Johannesburg South Africa. Participants will include men and women aged 18-65, reporting CLBP with or without leg pain. Prior to randomisation, participants will be categorised into nociceptive or neuropathic pain phenotypes using the painDETECT questionnaire. Participants will be randomly allocated into one of three groups: a) Standard physiotherapy treatment; b) standard physiotherapy treatment and pedometer based walking; and c) pedometer based walking only. Outcome measurements of pain, function, catastrophising, kinesiophobia, and treatment expectations will be recorded at initial assessment, at six and 12 weeks. Participants will wear pedometers from waking until bedtime daily (excluding bathing). This controls for walking done outside the walking programs. Pain diaries will be used for data collection of pain together with changes in walking speed, frequency and duration. Analysis will be on an intent to treat basis. The study will measure efficiency of the treatment by observing the drop-out rate and where possible, the related reasons. Observations will include inter and intra group differences in outcome measures. The researchers wish to study a conservative, equitable and quality solution to CLBP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Chronic Lower Back Pain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 11/08/2015
Actual trial start date 11/08/2015
Anticipated date of last follow up 01/03/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 147
Actual target sample size (number of participants) 147
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
EP 15/16 18 The Research Ethics Approval Committee for Health (REACH) University of Bath
EP 15/16 18 The Research Ethics Approval Committee for Health (REACH) University of Bath
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 a randomisation table created by a computer software program Allocation was determined by the holder of the sequence situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pedometer driven walking program 1-7 days per week. 20 minutes for week 1, increasing by 10%(2 minutes) every week. 12 weeks This will begin with 20 minutes walking at the participant¿s self-selected speed. The walking time is to increase by 20% every second week (www.acsm.org). Participants will be instructed to walk daily unless this causes any pain. If it does, they will be asked to continue once the pain ceases or returns to baseline levels. Physiotherapy visits will consist of walking program supervision. The super 49
Experimental Group Standard physiotherapy and a pedometer driven walking program 3-9 physiotherapy sessions, 1-7 walks per week for 20 minutes increasing by 10% duration per week 12 weeks This will include:10-15 minutes of lumbar and gluteal massage,¿ 5-10 minutes of Maitland mobilisation according to which mobilisation relives the patient¿s symptoms,and ¿ 10 minutes of Lumbar stabilisation exercise consisting of isometric transversus abdominus contractions. The patient will recieve this between 3 and 9 times over 12 weeks. Additionallythey will be asked to complete a walking progr 49
Control Group Standard Physiotherapy 1-9 treatments over 12 weeks 30 minutes manipulation, massage, isometric transversus abdominus exercise 49 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ LBP lasting for longer than 3 months and/or recurring episodes greater than 3 per year. ¿ Less than 150 minutes of intentional exercise per week. ¿ LBP with or without radiation into leg/s. ¿ Patients attending private practice physiotherapy. ¿ Age: 18-65 years. ¿ Patient must be able to walk a minimum of 20 minutes. ¿ Patient must be willing to participate in a 12 week study, which requires a minimum of three and a maximum of nine physiotherapy treatments mentioned in this RCT. ¿ Current pregnancy. ¿ Knowledge of a malignancy. ¿ Knowledge of rheumatic disease systemically causing lower back pain. ¿ Currently diagnosed with fibromyalgia. ¿ History of serious psychological or psychiatric illness (mild depression eligible for inclusion). ¿ LBP caused by involvement in a Workman¿s compensation claim or on-going litigation. ¿ Medically unfit to participate in exercise program. ¿ Acute/ recent spinal fractures. ¿ Any other current musculoskeletal injury or contraindication to increasing walking times, including and cardiorespiratory or other medical condition limiting exercise tolerance. ¿ Evidence of nerve root, spinal cord, or cauda equina compression indicating signs of neurogenic claudication. 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
Yes 10/08/2015 The Research Ethics Approval Committee for Health (REACH) University of Bath
Ethics Committee Address
Street address City Postal code Country
Building 1 West North 4.22, Bath BA2 7AY, United Kingdom University of Bath Bath BA2 7AY United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain daily for 12 weeks
Primary Outcome Function (Oswestry Disability Index) Baseline, after 6 weeks, after 12 weeks
Secondary Outcome Catastrophic thinking (Pain Catastrophic Scale) Baseline, after 6 weeks, after 12 weeks
Secondary Outcome Tampa Scale of Kinesiophobia Baseline, after 6 weeks, after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medicross Medical Centre corner of Malibongwe and Rabie roads Johannesburg 2195 South Africa
Dr Guy Teuwens Surgical rooms Corner pres. Fouche and Windsor way Johannesburg 2188 South Africa
Towers west medical centre corner of main and troye johannesburg 2000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Richard Feher post net suite 407 heathway centre Johannesburg 2195 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Omron 22 Friesland drive Johannesburg 1640 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr Guy Teuwen Market street Market street 2958 South Africa
Dr Alex Eckonomakis and Associates Corner of Rabie and Malibongwe streets randburg Johannesburg 2195 South Africa
Dr Imraan Tayob Towers West Medical Centre Corner of main and troye johannesburg 2195 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Richard Feher richphysio@vodamail.co.za +27 11 791 3454 postnet suite 407 heathway centre
City Postal code Country Position/Affiliation
Johannesburg 2195 South Africa Primary Investigator
Role Name Email Phone Street address
Public Enquiries Antonia Wadley Antonia.Wadley@wits.ac.za +270788028128 7 York road
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Local Supervisor (RSA)
Role Name Email Phone Street address
Scientific Enquiries Nikki Coghill N.coghill@bath.ac.uk +44(0)1225386623 Building 1 west 5. 116
City Postal code Country Position/Affiliation
Bath BA 7AY United Kingdom Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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