Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201508000907314 Date of Approval: 08/10/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Additional Lumbosacral Brace on the Outcome of Patients with Acute Low Back Pain at the Aga Khan University Hospital, Nairobi
Official scientific title Effect of Additional Lumbosacral Brace on the Outcome of Patients with Acute Low Back Pain at the Aga Khan University Hospital, Nairobi
Brief summary describing the background and objectives of the trial Low back pain (LBP) is a common problem world over affecting 60-90% of the population in their lifetime. It is a leading cause of hospital admission, absenteeism from work and consumption of healthcare funding. Up to 90% of patients suffering from low back pain do not have a serious pathology warranting imaging or further intervention besides symptom relief. These are categorised as having non-specific (mechanical) low back pain.The use of lumbosacral corset (brace) as a physical therapy for non-specific acute LBP has not been clearly supported with scientific evidence. However, it is commonly prescribed for this category of patients. It is important to assess the effect of this modality on the outcome of patients with non-specific acute LBP. Objective To assess the outcomes {change in pain score (VAS) and disability index (ODI)} of patients with non-specific acute low back pain treated with lumbosacral corset in addition to standard analgesic protocol compared to those on standard analgesic protocol alone over a 3 week duration of treatment at Aga Khan University Hospital, Nairobi, Kenya. Methods A single-blinded two-arm randomized controlled trial will be carried out on 110 consecutively sampled patients presenting with acute low back pain at the Aga Khan University Hospital (55 on each arm). The treatment arm will have a standard analgesic protocol and lumbosacral corset while the control arm will have the standard analgesic protocol only. Patients will be followed up for three weeks and assessed using the ODI tool and the VAS for pain. The mean change in ODI and VAS will be calculated using th
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,low back pain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2013
Actual trial start date 01/04/2015
Anticipated date of last follow up 01/04/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 82
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 consecutive sampling with patients picking sealed envelopes containing the arm allocation Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard analgesic protocol betapyn two tabs thrice a day if necessary AND airtal 100 milligrams twice a day when necessary for one week until review at the appointed follow-up time standard analgesic protocol 41 Active-Treatment of Control Group
Experimental Group Lumbosacral Corset in addition to the standard analgesia protocol appropriate size of lumbosacral corset IN ADDITION TO betapyn two tabs thrice a day if necessary AND airtal 100 milligrams twice a day when necessary 3 weeks Patients who are randomized into the intervention arm will have the appropriate size of lumbosacral corset (SuperOrtho TM) supplied within 24 hours of recruitment and wear them all the time except when asleep or when taking a shower. They will also have the standard analgesia as prescribed for the control arm. 41
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Acute low back pain patients aged 18-60 years. An episode of acute low back pain is defined as pain bound by 12th rib superiorly, gluteal creases inferiorly without leg pain, occurring over a duration of up to 6 weeks (van tulder-european guidelines, de vet ¿definitions) ¿ Consenting ¿ Red flags (indicators of serous pathology as picked from history and physical examination) o age less than 15 or more than 60 years o history of trauma or injury to the back o thoracic spine pain o past history of cancer o prolonged use of steroids o unexplained weight loss o symptoms of cord compression with focal deficits (saddle anaesthesia, limb weakness, urine incontinence or retention, cauda equina syndrome) o structural deformity of the back o fever and signs of infection - present or past (urinary infection, TB) ¿ Those who have used a lumbar corset before ¿ Patient who have already used the analgesics before ¿ Patients who have had spine surgery. ¿ Patients suffering from heart or respiratory disease ¿ Pregnant patients ¿ Patients already on the analgesic protocol with worsening pain 18 Year(s) 60 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 20/02/2015 The Aga Khan University Hospital, Nairobi Research and ethics Committee
Ethics Committee Address
Street address City Postal code Country
30270, 3rd Parklands Avenue Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome back specific disability as measured on the Oswestry disability Index at initial assessment, at end of first week, at end of second week, at end of third week
Secondary Outcome change in Pain score as measured through visual analogue score (VAS) f at initiation, at the end of first week, end of second week, end of third week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital 30270-00100, 3rd parklands avenue Nairobi +254 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
departmental research funding for residents' dissertations 3rd parklands. 30270-00100 Nairobi +254 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan Unviersity Hospital, Research Office 3rd parklands. 30270-00100 Nairobi +254 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Akil Fazal 30270, Nairobi 00100 Kenya
hassan Said 30270, Nairobi 00100 Kenya
Parmenas Oroko 30270, Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator aruyaru mwenda stanley.aruyaru@aku.edu 254720921267 3rd parklands avenue. 30270-00100
City Postal code Country Position/Affiliation
-Nairobi 00100 Kenya aga Khan University, Department of surgery
Role Name Email Phone Street address
Public Enquiries aruyaru Mwenda arumwesta@gmail.com +254720921267 3 Parklands Avenue, 30270-00100
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya principal research
Role Name Email Phone Street address
Scientific Enquiries aruyaru Mwenda arumwesta@gmail.com +254720921267 3 Parklands Avenue, 30270-00100
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya principal research
REPORTING
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