Plain English Summary
Background and study aims
Low Back Pain (LBP) is a very common symptom experienced by a high number of the population. Mostly, LBP symptoms resolve with time or conservative treatment. It has been proposed that imaging, MRI mainly, can negatively impact patient's recovery in terms of high consumption of pain killers, frequent visits to the doctors and elevating the anxiety and fear of the patients. This study is set to examine whether providing physiotherapy in secondary care level hospitals instead of MRI imaging is feasible and acceptable.
Who can participate?
Patients with non-specific LBP, no underlying serious pathology, who are referred to spine clinics in a secondary care center in Riyadh, Saudi Arabia aged from 18-65. There should be no recorded of MRI or physiotherapy in the past 6 months.
What does the study involve?
The patients will be randomized into two groups. the first group will be referred to have physiotherapy immediately. the second group (routine practice) will have MRI for their spine then discuss the result with the doctor before being referred to physiotherapy.
What are the possible benefits and risks of participating?
There are no expected benefits or associated risks from participating in this study.
Where is the study run from?
King Fahad Medical City (Saudi Arabia)
When is the study starting and how long is it expected to run for?
October 2015 to July 2018
Who is funding the study?
Saudi Spine Society (Saudi Arabia)
Who is the main contact?
Dr Ahmed Alhowimel, a.alhowimel@psau.edu.sa
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ahmed Alhowimel
ORCID ID
http://orcid.org/0000-0002-2936-7581
Contact details
3948 Alhabtah Street
unit 3
Riyadh
12989-6769
Saudi Arabia
+966 0553470558
a.alhowimel@psau.edu.sa
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Feasibility study and process evaluation of MRI plus physiotherapy vs. physiotherapy alone in non-specific chronic low back pain among patients in Saudi Arabia
Acronym
Study hypothesis
It is not known whether altering the practice of routine MRI use in Saudi Arabia would be acceptable to healthcare practitioners and patients and lead to improved psychosocial and disability outcomes. Therefore, this study will seek to examine the feasibility and acceptability of conducting an RCT to answer the following question: Does MRI diagnosis negatively influence psychosocial and disability outcomes in patients with CLBP who are undergoing physiotherapy?
Ethics approval
1. Approved 21/12/2016, Research Ethics Committee of the Faculty of Medicine and Health Science at the University of Nottingham (Medical School, Queen's Medical Centre Campus, Nottingham, NG7 2UH; louise.sabir@nottingham.ac.uk; +44(0)115 8232561), ref: OVS 18082016
2. Approved 21/11/2016, King Fahad Medical City (Riyadh, Saudi Arabia; +966 12889999; okasule@kfmc.med.sa), ref: H-01-R-R-012
Study design
Single-center two-arm non-inferiority feasibility randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic low back pain
Intervention
MRI+ Physiotherapy
Participants allocated to the MRI group were sent for an MRI scan of the lumbar spine, and a follow-up visit was planned to discuss the results. The time interval to undergo MRI ranged from 3 to 6 weeks. After discussing the results with their doctor, the patients were referred to physiotherapy. Next, another copy of the questionnaire booklet was completed by the participants after finishing the physiotherapy treatment, which lasted for a period of 2 weeks to 4 weeks.
Early Physiotherapy
Following allocation participants in the control arm (namely, the non-MRI group) were immediately asked to complete the booklet of questions and standard questionnaires. Participants were then referred to a physiotherapist for treatment, and the time required to initiate physiotherapy ranged from 1 week to 2 weeks. After completing the physiotherapy treatment programme, which lasted for 2 weeks to 4 weeks, the second assessment was taken
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The feasibility and acceptability of a large scale RCT:
1. Recruitment: Recruit at least 24 participants
2. Follow-up: If there is no more than 20% of loss to follow-up
3. Acceptability: If most participants interviewed stated that randomisation is acceptable and if at least 65% of eligible patients consent to participate in the trial
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/10/2015
Overall trial end date
29/07/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 – 65 years
2. Complaint of CLBP with no clear medical diagnosis (malignancy, fracture, infection, spinal stenosis, spondylolisthesis, or inflammatory disease)
3. Pain persisting for more than 3 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
The sample size (n=36) was calculated from the number of patients matching the inclusion criteria who visited spine clinics in the 3 months prior to conducting the study. The estimated non-consent rate of 50%, suggested 6 new patients to be randomized per month.
Total final enrolment
16
Participant exclusion criteria
1. Pregnancy
2. New mother <6 months postpartum
3. Those who had undergone pain-relieving procedures (injection or denervation) in the previous 3 months
4. Those who showed evidence of neurological impairment specific to LBP and received physiotherapy treatment for their LBP and/or MRI scan in the last 6 months prior to recruitment
Recruitment start date
01/03/2018
Recruitment end date
24/07/2018
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
King Fahad Medical City
Kurais Street
Riyadh
12231
Saudi Arabia
Sponsor information
Organisation
Saudi Spine Society
Sponsor details
7432 Ath Thumamah Road
As Sahafah
Riyadh
-
Saudi Arabia
+966 0114348837
info@saudispine.org
Sponsor type
Other
Website
Funders
Funder type
Research organisation
Funder name
Saudi Spine Society
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
01/09/2020
Participant level data
Other
Basic results (scientific)
Publication list
https://www.researchsquare.com/article/rs-16388/v1
Publication citations
Additional files
- ISRCTN14405580_PROTOCOL.pdf uploaded 07/08/2020