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.: PACTR201901867358252 Date of Approval: 25/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of the Effects of Positional Release Therapy and Lumbar Stabilisation Exercises in the Management of Chronic Mechanical Low Back Pain
Official scientific title Comparison of the Effects of Positional Release Therapy and Lumbar Stabilisation Exercises in the Management of Chronic Mechanical Low Back Pain
Brief summary describing the background and objectives of the trial Many studies have examined the RCTs into effect of positional therapy in the management of low back pain. However, most of these trials are of low quality due to small sample sizes and improper blinding
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Randomised Controlled Trials
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Positional Release Therapy compared with Lumbar Stabilisation Exercise
Anticipated trial start date 28/01/2019
Actual trial start date 29/01/2019
Anticipated date of last follow up 29/03/2019
Actual Last follow-up date 29/03/2019
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants) 56
Recruitment status Completed
Publication URL Not Yet Published
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PRT GROUP 2 TIMES IN A WEEK FOR 6 WEEKS Positional Release Therapy will be given to this group 19
Experimental Group LSE GROUP 2 TIMES IN A WEEK FOR 6 WEEK This group will receive lumbar stabilization exercises 20
Control Group CONTOL GROUP 2 TIMES IN A WEEK FOR 6 WEEKS This group will receive unsupervised back stretching exercises 17 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. patients with chronic mechanical LBP 2. Patients aging from 18 to 65years 1. Patients who have spinal surgery 2. Patients who have been hospitalized 3. Patients with systemic problems Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 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 24/02/2016 MINISTRY OF HEALTH DUTSE
Ethics Committee Address
Street address City Postal code Country
DANMASARA DUTSE JIGAWA ATATE DUTSE 7200 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome NUMERIC PAIN RATING SCALE, MODIFIED OSWESTRY DISABILITY INDEX, SHORT FORM-12 HEALTH SURVEY QUESTIONNAIRE AT BASELINE AND AFTER 6 WEEKS
Secondary Outcome GLOBAL RATING OF CARE SCALE AT BASELINE AND AFTER 6 WEEKS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
RASHEED SHEKONI SPECIALIST HOSPITAL DANMASARA ROAD DUTSE DUTSE 7200 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
MUSA SANI DANAZUMI MACHINA ROAD, FEDERAL MEDICAL CENTER, NGURU, YOBE STATE, NIGERIA NGURU 630101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Dr Usman Zakari AKTH Zaria Road KANO 300100 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
MUSA SANI DANAZUMI YOBE 630101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator USMAN USMAN ZAKARI usmanzaks@gmail.com +8035307341 AKTH Zaria Road
City Postal code Country Position/Affiliation
KANO 30010 Nigeria Chief Pysiotherapist
Role Name Email Phone Street address
Public Enquiries BASHIR BELLO nurubash@gmail.com +8037019137 AKTH Zaria Road
City Postal code Country Position/Affiliation
k 30010 Nigeria SENIOR LECTURER
Role Name Email Phone Street address
Scientific Enquiries MUSA SANI DANAZUMI musadanazumisani@gmail.com +8145123496 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
YOBE 630101 Nigeria PHYSIOTHERAPIST
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants demographics, informed consent, pre-test and post-test scores Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of completion of the study A link/address will be given
URL Results Available Results Summary Result Posting Date First Journal Publication Date
10.1615/CritRevPhysRehabilMed.2020032738 No
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