The Effect of Graded Activity and Pain Education (GAPE) for Patients Early After Lumbar Spinal Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Change from baseline in sedentary behavior (sitting or reclining/lying posture)
研究概览
简要总结
Background An increasing number of patients with chronic low back pain (CLBP) undergo lumbar spinal fusion (LSF). Unfortunately, a substantial part of the patients still has persistent pain, functional disability and poor quality of life after surgery. Research in the field of rehabilitation after LSF call for high quality research to focus on active approaches which incorporate an early bio-psycho-social focus. A focus which include the patient's context, experiences and thoughts even more in the clinical decision making.
The primary objective of this trial is to examine the effect of an early active rehabilitation-intervention consisting of Graded Activity and Pain Education (GAPE) on sedentary behavior in a population of patients undergoing LSF. The secondary objectives are to examine the effect of GAPE on disability, pain, fear of move-ment, self-efficacy for exercise and health related quality of life.
Methods:
The study is a randomized controlled trial planned to include 144 patients after LSF caused by degeneration of the lumbar spine (including spondylolisthesis). The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of 9 individual sessions, with an overall purpose to influence the patient beliefs and thoughts about movement and pain towards increased self-efficacy for exercise and decreased fear of movement. A physiotherapist will in close collaboration with the patient plan GAPE based on an in-depth pain-anamnesis, individually set functional goals and observations of the patients in their homes. The primary outcome will be "reduction in sedentary behavior" measured by an accelerometer. Sec-ondary outcome will include disability, pain, fear of movement, self-efficacy for exercise and quality of life. Data will be collected at baseline (pre-surgery), and at 3, 6- and 12-months post-surgery.
详细描述
Introduction:
Over half a Billion people worldwide report low back pain (LBP), and it is the leading cause of disability at all levels of income and age groups. For the majority of people with LBP the condition has a natural course and the pain will diminish over time, but for a small percentage the conditions turns into a chronic state with significant levels of life disruption, healthcare costs and economic losses and even premature death. Lumbar spinal fusion (LSF) is a widely adopted surgical procedure for the treatment of persistent LBP, with the aim of relieving pain and increasing functional ability. Over recent decades a substantially increasing number of patients with chronic low back pain (CLBP) undergo LSF in the western world.
Unfortunately, a substantial part of the patients undergoing spine surgery still have persistent pain, functional disability and poor quality of life 4 and 8-10 years after surgery. A report from the Swedish Spine register shows that pain level remains the same 1-5 years after LSF for 25 % of the patients, and consumption of medication remains unchanged in almost 50 % of the patients.
Rationale:
The majority of patients (70 %) planned for spine surgery have fear of movement, and it is well supported in the literature that fear of movement, avoidance coping, negative affect and depression postoperative are associated with persistent pain and function after spine surgery up to 3 years postoperative. Individual differences of pain related coping strategies after LSF also seems to have an influence on the patient's sedentary behavior postoperative.
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 (Outcomes Assessor)
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
- •Patients from the Capital Region of Denmark undergoing LSF at Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup from 23st of September 2019 to 30st marts 2021 and fulfilling the following criteria:
- •Low back pain > six months
- •Undergoing an instrumented spinal posterior fusion of 1-2 spinal segments for degeneration of the lumbar spine, with or without an intervertebral cage placed from the anterior approach, posterior approach or from a lateral access.
- •Degenerative conditions include disc herniation, spinal stenosis, spondylosis with or with-out myelopathy and spondylolisthesis.
- •Read and understand Danish
- •Lives no more than 1 ½ hour of transportation from Rigshospitalet, Glostrup
排除标准
- •Has previously been through an LSF
- •One or more of following conditions (infection, neoplasm, metastasis, metabolic bone dis-ease, fractures, post-traumatic vertebral compression/deformity or other known autoimmune arthropathies)
- •Are cognitively or otherwise unable to give informed consent and adhere to the study program
- •Other special conditions where a patient is judged not able to participate in the intervention by the surgeon or researcher (HT) (weakness caused by very high age, extreme poorly functional level, other serious comorbidities)
结局指标
主要结局
Change from baseline in sedentary behavior (sitting or reclining/lying posture)
时间窗: 3 months post-surgery
Sedentary behavior will in this study be defined as: "Any waking behavior characterized by a sitting or reclining/lying posture". Sedentary behavior will be assessed objectively as the number of minutes per day the patient is sedentary (lying down and sitting) measured by SENS motion activity measurement system. SENS is a small accelerometer placed within a small plaster to be worn on the patient's thigh. The SENS motion system is considered a reliable and valid device for measuring sedentary behavior. The patients will wear the accelerometer for 7 consecutive days during the week before surgery, and in 7 days at three- and 12-months post-surgery.
次要结局
- Visual Analogue Scale (VAS pain): Pain(Baseline, 3, 6 and 12 months post-surgery)
- Tampa scale of Kinesiophobia: Fear of movement(Baseline, 3, 6 and 12 months post-surgery)
- Change from baseline in sedentary behavior (sitting or reclining/lying posture)(12 months)
- Ostwestry Disability Index: Disability(Baseline, 3, 6 and 12 months post-surgery)
- EuroQol 5: Health-related quality of life(Baseline, 3, 6 and 12 months post-surgery)
- Self-efficacy for exercise scale: Self-efficacy for exercise(Baseline, 3, 6 and 12 months post-surgery)
- Patient satisfaction with results of the surgery(Baseline, 3, 6 and 12 months post-surgery)
研究者
Heidi Tegner
Principal Investigator, PT, MScH
Rigshospitalet, Denmark