Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion Surgery - A Single-case Experimental Design Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Patient-specific goal
研究概览
简要总结
Aim This study aims to assess the effectiveness of an early intervention comprising individually tailored physiotherapy, including dialogue, education, and graded activity, following lumbar spinal fusion surgery. The effectiveness will be evaluated on patient-specific goals, physical activity, pain intensity, pain interference, fear of movement, and pain self-efficacy for patients after a lumbar spinal fusion.
详细描述
In 2023, above 1400 patients underwent lumbar spinal fusion (LSF) in Denmark to treat CLBP. LSF aims to relieve pain by eliminating movement between joints by fusing one or more adjacent vertebrae. The use of LSF has been increasing because of the ageing population and because of improvements in surgical techniques and technologies.
Unfortunately, despite LSF surgery, many patients are not improving their physical activity level post-surgery, and inactivity is associated with an increased risk of disease mortality.
Therefore, healthcare professionals must address physical activity in post-surgical rehabilitation to help patients achieve healthy behaviour after surgery.
To perform physical activity, both physiological, psychological, and social factors have an influence. Further, qualitative interviews with patients undergoing LSF reveal significant concerns about engaging in physical activity after surgery. It thereby seems important that a rehabilitation approach includes a bio-psycho-social approach to incorporate the complexity of physical activity.
Rehabilitation involving physical exercises combined with a cognitive behavioural approach (CBA) has shown beneficial effects on short- and long-term functional outcomes in patients undergoing LSF. The purpose of CBA is to provide patients with techniques that can lead to a sense of control over their lives, despite pain. The approaches have no sharply defined treatment modalities but include a range of techniques that modify the behavioural, cognitive, affective, and sensory aspects of pain. Tegner et al. supported the evidence of a CBA in an RCT by showing that CBA was safe to start with just after LSF and significantly affected fear of movement and sedentary behaviour compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Full blinding is not feasible in this MBD. Allocation to baseline length will be concealed until the intervention is initiated. The randomisation schedule will be generated by co-investigator Jan Christensen.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The investigators will in total include 12 patients undergoing an LSF from the Centre for Rheumatology and Spine Diseases at Rigshospitalet, Denmark.
- •Before inclusion, a pilot of three participants will be performed.
- •Inclusion Criteria for all included:
- •≥ 18 years of age
- •Low back pain (LBP) > 3 months
- •Read and understand the Danish language
- •The participants should be a part of Frederiksberg Municipality and Copenhagen Municipality (in Denmark)
排除标准
- •Post-traumatic vertebral compression/deformity
- •Patients with the following conditions (infection, neoplasm, metastasis, metabolic bone disease, fractures or other known autoimmune arthropathies)
- •Patients with patient-related circumstances (physical or mental status) that impede their ability to give informed consent and adhere to the study program (e.g., dementia, developmental disorders, or substance-induced cognitive impairment)
- •Other special conditions, where the patient is judged by the surgeon as inappropriate to participate
研究组 & 干预措施
SOGA - 14 days post-surgery
The intervention SOGA will start 14 days after the participants lumbar spinal fusion.
干预措施: SOGA - Socratic dialogue and Graded Activity (Behavioral)
SOGA - 18 days post-surgery
The intervention SOGA will start 18 days after the participants lumbar spinal fusion.
干预措施: SOGA - SOcratic dialougue and Graded-Activity (Behavioral)
SOGA - 22 days post-surgery
The intervention SOGA will start 22 days after the participants lumbar spinal fusion.
干预措施: SOGA - SOcratic dialogue and Graded-Activity (Behavioral)
SOGA - 26 days post-surgery
The intervention SOGA will start 28 days after the participants lumbar spinal fusion.
干预措施: SOGA - SOcratic dialogue and Graded Activity (Behavioral)
结局指标
主要结局
Patient-specific goal
时间窗: Daily, from 1 day post-surgery to 3 months post-surgery
The patient-specific goal will be reported as the primary outcome. To evaluate the participants' ability to reach their overall goal of the surgery and following rehabilitation, the participants are asked, together with the PI, to formulate an individualised, measurable, achievable, realistic/relevant, and time-bound (SMART) goal. The goal should be manageable to achieve within the three-month intervention period. The participant will evaluate their ability to reach their goal on a scale from 0 ('unable to do') to 10 ('able to perform at the same level as before the injury or problem).
次要结局
- Physical activity(Daily, from 1 day post-surgery to 3 months post-surgery)
- Pain intensity(Daily, from 1 day post-surgery to 3 months post-surgery)
- Fear of movement(Daily, from 1 day post-surgery to 3 months post-surgery)
- Pain interference(Daily, from 1 day post-surgery to 3 months post-surgery)
- Pain self-efficacy(Daily, from 1 day post-surgery to 3 months post-surgery)
研究者
Heidi Tegner
Research Physiotherapist, Post doc
Rigshospitalet, Denmark