Department of Biomechanics and Sport Injuries, Faculty of Physical Education and Sport Sciences, Kharazmi University, Tehran, Iran.
Sports Injury and Corrective Exercises, Kharazmi University, Tehran, Iran.
Trials. 2023 Sep 8;24(1):573. doi: 10.1186/s13063-023-07617-1.
Low 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.
A 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.
This 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.
IRCT Iranian Registry of Clinical Trials IRCT20210927052616N1. Registered on November 03, 2021.
下腰痛（LBP）是一种多因素疾病，会给社会带来广泛的身心负担。以患者为导向的目标设定方法已显示出改善慢性 LBP 的潜力。然而，将其与补充干预措施结合使用的研究甚少。因此，本文介绍了一项随机对照试验（RCT）的方案，旨在研究以患者为导向的目标设定方法结合疼痛神经科学教育（PNE）或手动治疗（MT）对慢性 LBP 患者的疗效。
通过在医院和大学展示传单，共招募 105 名患有慢性 LBP 的患者，符合研究标准的患者将随机分配到以患者为导向的目标设定方法与 PNE 组和/或 MT 方案组和/或对照组。主要结局指标为疼痛强度和残疾。次要结局指标包括生活质量、抑郁、焦虑和压力、恐惧回避信念、运动恐惧、疼痛自我效能感、灾难性疼痛、疼痛神经生理学和中枢敏感性。所有结果将在接受治疗后 2 个月（即测试后）以及 4 个月和 12 个月（即随访后）记录。伊朗运动科学研究所的研究伦理委员会批准了该试验的方案（IR.SSRC.REC.1400.084）。将从所有参与者处获得书面、知情同意书。所有方法均将按照赫尔辛基宣言的伦理标准以及相关指南和规定进行。我们将通过同行评审的出版物和会议报告传播研究结果，并将其发送给参与者。
本试验将证明哪种补充干预措施可以更好地提高以患者为导向的目标设定方法治疗 LBP 的效果。如果成功，结果可能对运动训练师、物理治疗师和医疗保健从业者产生影响。
IRCT 伊朗临床试验注册处 IRCT20210927052616N1。于 2021 年 11 月 03 日注册。
