The effect of patient-led goal setting approach combined with pain neuroscience education or manual therapy in patients with chronic low back pain: protocol for a parallel-group randomized controlled trial

Trials

Study Protocol

Sahar Soheili¹  Mahdi Hosseinzadeh²  Amir Letafatkar³ 

[1] Department of Biomechanics and Sport Injuries, Faculty of Physical Education and Sport Sciences, Kharazmi University, Tehran, Iran;Department of Sport Injuries and Corrective Exercises, Sport Sciences Research Institute, No. 3, 5Th Alley, Miremad Street, Motahhari Street, 1587958711, Tehran, Iran;Sports Injury and Corrective Exercises, Kharazmi University, Tehran, Iran;

关键词: Patient-led goal setting;    Pain neuroscience education;    Chronic low back pain;    Manual therapy;   

DOI  :  10.1186/s13063-023-07617-1

 received in 2023-04-11, accepted in 2023-08-31,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundLow back pain (LBP) is a multifactorial disorder associated with a high range of physical and psychological burden on the society. Patient-led goal-setting approach has shown potential effects for improving chronic LBP. However, there are few studies investigating its benefits when combined with a supplementary intervention. This paper, therefore, presents a protocol for a randomized control trial (RCT) to study the effect of a patient-led goal-setting approach combined with pain neuroscience education (PNE) or manual therapy (MT) among patients with chronic LBP.MethodsA total of 105 patients suffering from chronic LBP will be recruited via flyers displayed in hospitals and universities, and those meeting the study’s criteria will randomly be allocated into a patient-led goal-setting approach with the PNE group, and/or with the MT program group, and/or a control group. The primary outcomes will be the pain intensity and disability. Secondary outcomes include quality of life, depression, anxiety and stress, fear avoidance beliefs, kinesophobia, pain self-efficacy, catastrophic pain, neurophysiology of pain, and central sensitivity. All the outcomes will be recorded at 2 months after receiving the treatment as post-test sessions and after 4 and 12 months as follow-up sessions. The Ethics Committee in Research at Sport Sciences Research Institute of Iran approved the protocol of this trial (IR.SSRC.REC.1400.084). Written, informed consent to participate will be obtained from all participants. All methods will be conducted in accordance with the ethical standards of the Declaration of Helsinki and in accordance with relevant guidelines and regulations. We will disseminate the findings through peer-reviewed publications and conference presentations and send them to the participants.DiscussionThis trial will demonstrate which supplementary intervention can better improve the impact of a patient-led goal-setting approach to treat LBP. If successful, the results will potentially have implications for athletic trainers, physiotherapists, and health care practitioners.Trial registrationIRCT Iranian Registry of Clinical Trials IRCT20210927052616N1. Registered on November 03, 2021.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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