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.: PACTR202004875972379 Date of Approval: 10/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Development and Validation of a Tool to Measure Patient Satisfaction with the Management of Low Back Pain
Official scientific title Development and Validation of a Tool to Measure Patient Satisfaction with the Management of Low Back Pain
Brief summary describing the background and objectives of the trial Background and Aim: Patient satisfaction has emerged as an important outcome following the emergence of evidence-based practice. In spite of this, a tool to measure patient satisfaction with the management of low back pain (LBP) is still lacking. This study would like to develop and validate a tool to measure patient satisfaction with the management of LBP. Design: This will be designed as a tool development and validation study. A single-arm clinical trial (Reg No :) will also be conducted to measure tool’s responsiveness. Tool Development: The tool will be developed based on the themes that emerged from our previous qualitative study [1]. The strict guidelines developed by the “quality criteria for measurement properties of health status questionnaires” will be followed. The tool will be pilot tested among the study population and the final version will be developed after peer debriefing. Psychometric Testing: Validity, reliability and responsiveness of the tool will be examined using appropriate statistical techniques. The psychometric testing will be conducted according to the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines. 1. Danazumi MS et al. A Qualitative Study into Nigerian Patients’ Satisfaction with Physiotherapy Management of Low Back Pain. IOSR-JNHS; 2019, 8(1), 27-32.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Tool Development
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/10/2020
Actual trial start date 05/10/2020
Anticipated date of last follow up 04/10/2021
Actual Last follow-up date 04/10/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Not yet 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 Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MANUAL THERAPY 3 times in a week 8 weeks Different types of manual therapy techniques will be administered 50
Control Group Exercises therapy 3 times in a week 8 weeks Lumbar stabilization and stretching exercises will be given 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All individuals with low back pain of any type and duration Participants having commobidities Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 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
No 20/04/2020 FEDERAL MEDICAL CENTER NGURU YOBE STATE NIGERIA
Ethics Committee Address
Street address City Postal code Country
MACHINA ROAD Nguru 630101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Satisfcation of care, Pain, global rating of change at baseline and after 8 weeks
Secondary Outcome Disability at baseline and after 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTER NGURU MACHINA ROAD NGURU 630101 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
Primary Sponsor MUSA SANI DANAZUMI MACHINA ROAD NGURU 630101 Nigeria SELF SPONSORSHIP
COLLABORATORS
Name Street address City Postal code Country
ABDULSALAM MOHAMMED YAKASAI MACHINA ROAD NGURU 630101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MUSA SANI DANAZUMI musadanazumisani@gmail.com +8145123496 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria ORTHOPEDIC AND SPORTS PHYSIOTHERAPIST
Role Name Email Phone Street address
Public Enquiries ABDULSALAM MOHAMMED YAKASAI abdulpeace1@gmail.com +8035307341 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria NEUROPHYSIOTHERAPIST
Role Name Email Phone Street address
Scientific Enquiries SHEHU USMAN IBRAHIM umanik28@gmail.com +8037019137 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria ORTHOPEDIC AND SPORTS PHYSIOTHERAPIST
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes ALL PATIENTS OUTCOMES INCLUDING PAIN, DISABILITY AND THE NEW TOOL TO BE DEVELOPED Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol BY THE YEAR 2022 PUBLICATION IN PEER REVIEWED JOURNAL
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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