Condition category
Musculoskeletal Diseases
Date applied
02/08/2020
Date assigned
04/08/2020
Last edited
07/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

http://saudispine.org/

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

Editorial Notes

07/08/2020: Uploaded protocol (not peer reviewed) Version n/a. 04/08/2020: Trial’s existence confirmed by The University of Nottingham