Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 17, 2021
Open Peer Review Period: Jun 17, 2021 - Aug 12, 2021
Date Accepted: Oct 21, 2021
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Rehabilitation Program for individuals with Chronic Low Back Pain: Protocol for a Randomized Clinical Trial
ABSTRACT
Background:
Low back pain (LBP) is the leading cause of disability worldwide. Physical exercise as a treatment is beneficial for the improvement quality of life (QOL) in these patients and it widely accepted as well.
Objective:
To develop a protocol for a feasibility study designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors in patients with chronic LBP after 8 weeks of randomization.
Methods:
This is a study protocol for a randomized controlled trial that consists of individuals with chronic LBP aged between 18 and 65 years. Subjects will be allocated through block randomization in one of the following groups: Motor Control Exercises (MCE), Pain Education, MCE + Pain Education, and Usual Care. The primary outcome will be pain intensity, and secondary outcomes will be pressure pain threshold measured through digital algometer, LBP-related disability, fears and beliefs, fear of movement, QOL, mood states, levels of depression and anxiety.
Results:
This trial was funded in 2018 and it was approved by Human Research Ethic Committee in September 2018. We are starting the patient’s recruitment, as it involves patients on a public service waiting list and needs the health manager's permission to start the data collection considering the current health scenario. Results are expected to be achieved by April 2022.
Conclusions:
This trial will provide preliminary data regarding the feasibility and safety of MCE and Pain Education in patients with low back pain. It will also provide preliminary outcome data used to identify the intervention more efficient and what level of health care should be implemented in public health services. Clinical Trial: RBR-2xx2r2
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.