Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR201702001728564 Date of Approval: 26/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Graded Activity on Low Back Pain in Patients with Type 2 Diabetes
Official scientific title Effects of Graded Activity Protocol on Clinical and Psychosocial Attributes of Patients with Concomitant Low-Back pain and Type 2 Diabetes Mellitus
Brief summary describing the background and objectives of the trial Low Back Pain (LBP) is a common public health problem. It is documented in literature that graded activity protocol (GAP) is effective in managing chronic LBP in the general population. However, there is limited evidence that GAP only or the addition monitored physical activity (PA), tailored towards the additional problems of T2DM which perpetuate LBP, is effective in the management of CLBP in this patient population. Research design: The research design was three group pre-test post-test randomized clinical trial. Ethical approval was sought and obtained from the University of Ibadan/ University College Hospital Health Research and Ethics Committee (UI/EC/13/0093) and University of Benin Teaching Hospital Health Research and Ethical committee (ADM/E22/VOL.VII/1187) respectively. Fifty-eight patients with concomitant LBP and T2DM took part in this randomized clinical trial for 12 weeks. They were consecutively randomized into GAP Group (GAPG) (n=29) and GAP with daily monitored PA Group (GAPPAG) (n=29). They were recruited from the Medical Outpatient and Physiotherapy Departments of Federal Medical Centre, Ido-Ekiti, Nigeria and University of Benin Teaching Hospital, Benin-City, Nigeria respectively. Age and sex-matched (n=29) non-diabetic individuals with LBP were assigned to a third group {GAP in Non-Diabetic Group (GAPNDG)}. All participants received the GAP (functional capacity measurements, home/workplace visits, back school and a gradually increased sub-maximal exercise programme), while those in GAPPAG received additional daily monitored PA. Treatment components of the GAP were given twice weekly with outcomes assessed at the end of weeks 4, 8 and 12. Outcomes such as Pain Intensity (PI), Static Abdominal Musculature Endurance (SAME), Static Back Extensors Endurance and Haemoglobin A1c, activity limitation, Pain Self-Efficacy (PSE), Fear Avoidance Behaviour (FAB) and belief of consequence of back pain were assessed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Type 2 Diabetes and Low Back Pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/02/2013
Actual trial start date 06/03/2013
Anticipated date of last follow up 31/08/2016
Actual Last follow-up date 26/07/2016
Anticipated target sample size (number of participants) 93
Actual target sample size (number of participants) 87
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
UI/EC/13/0093 University of Ibadan, Health Research and Ethics Committee, Biode building, Room T10, 2nd Floor
ADM/E22/VOL.VII/1187 University of Benin Teaching Hospital Health Research Committee, 1 Ugbowo, UBTH, Benin City
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 randomisation (block size 4, the block size was variable) Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Graded Activity Protocol for patients with type 2 diabetes Twice weekly one hour Graded activity protocol involved measurements of functional capacity such as abdominal muscle endurance, back extensors endurance as well as the six minutes walk test; a home and work place visit, back school and an individually tailored sub-maximal graded exercise- including back extension exercises, bicycle ergometry, squatting, curl ups, bent over dumb bell row 29 Active-Treatment of Control Group
Control Group Graded Activity Protocol for patients without type 2 diabetes Twice weekly one hour Graded activity protocol involved measurements of functional capacity such as abdominal muscle endurance, back extensors endurance as well as the six minutes walk test; a home and work place visit, back school and an individually tailored sub-maximal graded exercise- including back extension exercises, bicycle ergometry, squatting, curl ups, bent over dumb bell row 29 Active-Treatment of Control Group
Experimental Group Graded Activity and monitored daily physical activity for patients with type 2 diabetes twice weekly one hour The graded activity involved measurements of functional acapacity such as abdominal muscle endurance, back extensors endurance as well as the six minutes walk test; a home and work place visit, back school and an individually tailored sub-maximal graded exercise- including back extension exercises, bicycle ergometry, squatting, curl ups and bent over dumbbell row, monitored daily physical activity 29 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals diagnosed of T2DM with complaints of non-specific LBP of not less than 3 months duration were included in the study. Individuals with complaints of non-specific of not less than 3 months duration without any co-morbidity were eligible to participate as controls in this study. Individuals diagnosed with T2DM for not less than 1 year were eligible to participate in the study. Individuals who understood either of English or Yoruba language or both were eligible to participate in the study. Individuals with morbidities beside T2DM (like uncontrolled hypertension, stroke and asthma) were excluded from the study. Patients who were on insulin therapy or who had used insulin in the previous 6 months were excluded from the study. Individuals who presented with additional disabling conditions such as blindness and amputations were excluded from the study. Patients with red flags suggestive of serious spinal pathology with signs and symptoms of nerve root compromise (with at least two of the following: dermatomal sensory loss, myotomal muscle weakness and reduced lower limb reflexes) were excluded from the study. Patients with severe peripheral neuropathy were excluded from the study. 30 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 16/07/2013 University of Ibadan/ University College Hospital Health and Research Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Biode building, Room T10, 2nd Floor, Institute for Advanced Medical research and Training, College of Medicine, UCH road Ibadan 5116 Nigeria
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 08/04/2015 University of Benin Teaching Hospital Health Research and Ethics Committeee
Ethics Committee Address
Street address City Postal code Country
Lagos-Benin Expressway, Off Ugbowo Park, Benin-City Benin-City 1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity, Static Abdominal Muscular Endurance, Static Back Extensors Endurance, LBP-related disability, pain self-efficacy belief, fear avoidance behaviour and back pain consequences belief Baseline 4th Week 8th Week 12th Week
Secondary Outcome Fasting Blood sugar, glycosylated haemoglobin A1C Baseline 4th Week 8th week 12th week
Primary Outcome Pain Intensity,Static Abdominal Musculature Endurance, Static Back Extensors Endurance, Haemoglobin A1c, activity limitation, Pain Self-Efficacy,Fear Avoidance Behaviour, belief of consequence of back pain baseline 4th week 8th week 12th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital Lagos Ugbowo Express way, Off Ugbowo Park Benin-City 1111 Nigeria
Federal Medical Medical Centre 1, Hospital way Ido-Ekiti 201 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Opeyemi Idowu 35, ola lay out ile-ife 5114 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr A.F Adeniyi Plot 10, OJEWOLE LAYOUT, ADETOKUN, OLOGUNERU Ibadan Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Dr A.F Adeniyi Plot 10, OJEWOLE LAYOUT, ADETOKUN, OLOGUNERU Ibadan 23401 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Opeyemi Idowu opeyemi.idowu@uniben.edu +2347036872825 35,Ola lay out
City Postal code Country Position/Affiliation
benin-City Nigeria Lecturer/ University of Benin, Benin-City, Nigeria
Role Name Email Phone Street address
Public Enquiries Ade Adeniyi adefataiadeniyi@yahoo.co.uk +2348057325888 Plot 10, OJEWOLE LAYOUT, ADETOKUN, OLOGUNERU
City Postal code Country Position/Affiliation
IBADAN Nigeria Senior Lecturer/ University of Ibadan, Nigeria
Role Name Email Phone Street address
Public Enquiries Opeyemi Idowu opeyemi.idowu@uniben.edu +2347036872825 35,Ola lay out
City Postal code Country Position/Affiliation
benin-City Nigeria Lecturer/ University of Benin, Benin-City, Nigeria
Role Name Email Phone Street address
Scientific Enquiries Ade Adeniyi adeniyifatai@yahoo.co.uk +2348057325888 Plot 10, OJEWOLE LAYOUT, ADETOKUN, OLOGUNERU
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Lecturer/ University of Ibadan, Nigeria
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
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 18/01/2017 After meeting with my supervising professor, the study title had to be modified to accommodate the protocol name change EFFICACY OF GRADED ACTIVITY PROTOCOL ON CLINICAL AND PSYCHOSOCIAL ATTRIBUTES OF PATIENTS WITH CONCOMITANT LOW-BACK PAIN AND TYPE 2 DIABETES MELLITUS EFFICACY OF GRADED ACTIVITY PROTOCOL ON CLINICAL AND PSYCHOSOCIAL ATTRIBUTES OF PATIENTS WITH CONCOMITANT LOW-BACK PAIN AND TYPE 2 DIABETES MELLITUS
Section Name Field Name Date Reason Old Value Updated Value
Ethics CommitteeName 18/01/2017 Not included before now IssuingAuthority IssuingAuthority
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 18/01/2017 The commonly used term is graded activity and not exercise EFFECTS OF GRADED EXERCISE ON LOW BACK PAIN IN PATIENTS WITH TYPE 2 DIABETES EFFECTS OF GRADED ACTIVITY ON LOW BACK PAIN IN PATIENTS WITH TYPE 2 DIABETES
Section Name Field Name Date Reason Old Value Updated Value
Ethics CommitteeName 18/01/2017 It was not put before now IssuingAuthority IssuingAuthority
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 18/01/2017 Not included before now SECONDARY_ID SECONDARY_ID
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 09/02/2017 edit EFFECTS OF GRADED ACTIVITY ON LOW BACK PAIN IN PATIENTS WITH TYPE 2 DIABETES Effects of Graded Activity on Low Back Pain in Patients with Type 2 Diabetes
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 09/02/2017 edit EFFICACY OF GRADED ACTIVITY PROTOCOL ON CLINICAL AND PSYCHOSOCIAL ATTRIBUTES OF PATIENTS WITH CONCOMITANT LOW-BACK PAIN AND TYPE 2 DIABETES MELLITUS Effects of Graded Activity Protocol on Clinical and Psychosocial Attributes of Patients with Concomitant Low-Back pain and Type 2 Diabetes Mellitus
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 18/01/2017 Three groups of 29 participants were recruited and thus the change 74 87
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 18/01/2017 It was not put before now SECONDARY_ID SECONDARY_ID
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 09/02/2017 Modified CCT RCT
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 18/01/2017 It was changed to adequately give the study a definitive focus. This change was as a result of input by my supervising professor EFFICACY OF GRADED ACTIVITY ON CLINICAL AND PSYCHOSOCIAL ATTRIBUTES OF LOW-BACK PAIN PATIENTS WITH COMORBID TYPE II DIABETES MELLITUS EFFICACY OF GRADED ACTIVITY PROTOCOL ON CLINICAL AND PSYCHOSOCIAL ATTRIBUTES OF PATIENTS WITH CONCOMITANT LOW-BACK PAIN AND TYPE 2 DIABETES MELLITUS
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 18/01/2017 This was written properly to address the issue of sample size. There were 3 groups of equal sizes (29 per group). Low Back Pain (LBP) is a common public health problem. It is documented in literature that graded activity is effective in managing chronic low back pain (CLBP) in the general population. However, there is limited evidence that graded activity only or the addition monitored physical activity (PA) tailored towards the additional co-morbidities of T2DM which perpetuate LBP is effective in the management of CLBP in this patient population. Research design: The research design will be a three group pre-test post-test randomized clinical trial. Ethical approval was sought and obtained from the University of Ibadan/ University College Hospital Health Research and Ethics Committee (UI/EC/13/0093) and University of Benin Teaching Hospital Health Research and Ethical committee (ADM/E22/VOL.VII/1187) respectively. Seventy three consenting patients with non-specific chronic LBP and co-morbid T2DM were recruited for the study. They were recruited from the Medical Outpatient and Physiotherapy Departments of Federal Medical Centre, Ido-Ekiti, Nigeria and University of Benin Teaching Hospital, Benin-City, Nigeria respectively. However, only 62 individuals who met the inclusion criteria to participate in the study were randomized into each of graded activity only and graded activity plus monitored daily physical activity groups. Participants with non-specific LBP without any associated co-morbidity were also recruited as a comparison group and they received graded activity only as treatment. Interventions were carried out twice weekly and over a period of 12 weeks. Monitored daily PA was carried out by individuals in the third group daily for 12 weeks. Clinical outcomes such as pain intensity, static abdominal muscular endurance and static back extensors endurance, and psychosocial outcomes including LBP-related disability, pain self-efficacy beliefs, fear avoidance behaviour and belief of consequences of back pain were assessed. Data analysis as well as follow up are ongoing Low Back Pain (LBP) is a common public health problem. It is documented in literature that graded activity protocol (GAP) is effective in managing chronic LBP in the general population. However, there is limited evidence that GAP only or the addition monitored physical activity (PA), tailored towards the additional problems of T2DM which perpetuate LBP, is effective in the management of CLBP in this patient population. Research design: The research design was three group pre-test post-test randomized clinical trial. Ethical approval was sought and obtained from the University of Ibadan/ University College Hospital Health Research and Ethics Committee (UI/EC/13/0093) and University of Benin Teaching Hospital Health Research and Ethical committee (ADM/E22/VOL.VII/1187) respectively. Fifty-eight patients with concomitant LBP and T2DM took part in this randomized clinical trial for 12 weeks. They were consecutively randomized into GAP Group (GAPG) (n=29) and GAP with daily monitored PA Group (GAPPAG) (n=29). They were recruited from the Medical Outpatient and Physiotherapy Departments of Federal Medical Centre, Ido-Ekiti, Nigeria and University of Benin Teaching Hospital, Benin-City, Nigeria respectively. Age and sex-matched (n=29) non-diabetic individuals with LBP were assigned to a third group {GAP in Non-Diabetic Group (GAPNDG)}. All participants received the GAP (functional capacity measurements, home/workplace visits, back school and a gradually increased sub-maximal exercise programme), while those in GAPPAG received additional daily monitored PA. Treatment components of the GAP were given twice weekly with outcomes assessed at the end of weeks 4, 8 and 12. Outcomes such as Pain Intensity (PI), Static Abdominal Musculature Endurance (SAME), Static Back Extensors Endurance and Haemoglobin A1c, activity limitation, Pain Self-Efficacy (PSE), Fear Avoidance Behaviour (FAB) and belief of consequence of back pain were assessed.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 Pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 05/07/2018 Pactr update Other Musculoskeletal Diseases, Other