Feasibility Testing of a Pre-surgical Rehabilitation (Prehab) Program for Patients With Lumbar Spinal Stenosis: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Follow-up
研究概览
简要总结
The literature has shown evidence of the effectiveness of prehabilitation programs on post-operative recovery for musculoskeletal conditions; however, evidence for prehabilitation for lumbar spinal stenosis (LSS) is limited. Investigators have found that there is very low to low quality evidence for the effect of prehabilitation interventions for improving outcomes following lumbar spine surgery. Therefore, the purpose of this study will be to determine the feasibility of a prehabilitation program for patients undergoing LSS surgery, and pilot test the protocol to provide the foundation for future design of a larger, multicenter randomized controlled trial.
详细描述
Background:
Lumbar spinal stenosis (LSS) is the most common degenerative condition among older adults, and the leading reason older adults aged 65 and older undergo surgery. LSS is characterized by degenerative changes that lead to loss of intervertebral disc spaces, joint thickening, and enfolding of the ligaments surrounding the spine. These degenerative changes may cause compression of lumbosacral nerve roots resulting in the narrowing of central and vertebral canals known as neurogenic claudication (NC). The symptoms of NC include cramping, numbness or tingling, and muscle weakness in the lower back, buttocks, or one or both legs, with symptoms often intensifying with standing and walking.
The majority of individuals undergoing surgery for LSS are post-retirement age, have chronic low back pain, without access to private rehabilitation. This population is often severely deconditioned prior to surgery with weakness and atrophy of the muscles in the back, core, and lower limb. These preoperative factors have been shown to be predictors for postoperative LSS outcomes. Studies have shown evidence of the effectiveness of prehabilitation programs on post-operative recovery for other musculoskeletal conditions such as total knee arthroplasty. However, there appears to be a lack of high-quality evidence for the effect of prehabilitation interventions in improving outcomes for LSS surgery.
Research Aims:
The purpose of this study is to determine the feasibility of the program of care on a group of patients with LSS undergoing surgery, and determine the feasibility of the protocol for a randomized controlled trial.
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
- None
盲法说明
Blinding of participants and those delivering the intervention is not possible within rehabilitation trials and blinding of assessors is not possible when participants are not blinded, and outcomes are self-reported. Research coordinators involved in data collection and researchers involved in data analysis, however, will be blinded.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 20 weeks prior to date of LSS surgery
- •Older than 55 years of age
- •Scheduled for first spinal surgery
- •Can read and understanding English, with no significant visual or hearing impairment that would require additional support
排除标准
- •Known or suspected pathology (e.g., cancer, cauda equina syndrome)
- •Unable to engage in exercise due to other comorbidities
- •No access to the Internet
研究组 & 干预措施
Prehabilitation
The 8-week prehabilitation program will be delivered online using synchronous and asynchronous sessions delivered by either a physiotherapist, chiropractor or kinesiologist. There will be 4 individual exercises sessions delivered synchronously using Zoom or Physitrack in which motivational interviewing and graded activity exercises will be conducted. Participants will also be asked to exercise at least 3 times a week using the asynchronous exercise videos. The exercises will be individualized on participants functional ability and personal goals identified at baseline, with a focus on muscle strengthening, stretching, improving spinal flexibility and stability. There will be a booster session at 6-weeks post-op. Participants will also undergo 5 group educational sessions, which will provide information regarding: goal setting, pain education, self-management, pacing, post-operative expectations, exercise recommendations, and information regarding their upcoming surgery.
干预措施: Prehab for LSS (Other)
Usual Care
Participants in the control group will receive usual care as per surgeons' current practice. This generally consists of one session with an anesthesiologist, a nurse and access to our online videos.
干预措施: Usual Care (Other)
结局指标
主要结局
Follow-up
时间窗: Immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
1. Proceed with the study if 90% of participants follow-up at the end of the prehab intervention 2. Proceed with the study if 85% of participants follow-up at 6 months 3. Proceed with the study if 85% of participants follow-up at 12 months 4. Proceed with the study if 60% reported being likely to use this treatment again (\>7/10 on a Likert scale)
Patient Adherence
时间窗: During the 8-week Intervention
Measured by patient diary, app-based program 1. Proceed with study if 80% of participants attended all 4 exercise sessions 2. Proceed with study if 60% of participants report exercise at last 3x/week.
Recruitment Rate
时间窗: 20 weeks before LSS surgery
Proceed with study if 50% of eligible participants consent to participate within 4 months
Content Acceptability
时间窗: Immediately after the intervention (8-weeks)
Measured using a survey administered at the end of the 8-week intervention 1. Proceed with the study if 60% found treatment useful (\>7/10 on a Likert scale) 2. Proceed with the study if 60% found treatment helpful (\>7/10 on a Likert scale)
Format Acceptability
时间窗: Immediately after the intervention (8-weeks)
Measured using a survey administered at the end of the 8-week intervention 1. Proceed with the study if 60% found treatment delivery acceptability (\>7/10 on a Likert scale) 2. Proceed with the study if 60% of participants reported being likely to recommend this treatment (\>7/10 on a Likert scale) 3. Proceed with the study if 60% reported being likely to use this treatment again (\>7/10 on a Likert scale)
Burden
时间窗: Immediately after the intervention (8-weeks)
Proceed with the study if 60% reported being likely to use this treatment again (\>7/10 on a Likert scale)
次要结局
- Swiss Spinal Stenosis Questionnaire - Balance(20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively)
- Pain Catastrophizing Scale(20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively)
- Tampa Scale of Kinesiophobia(20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively)
- EQ-5D(20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively)
- The Oswestry Disability Index(20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively)
- SF-12(20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively)
- 6-item Chronic Disease Self-Efficacy Scale(20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively)
- Ecological Momentary Assessment(During the 8-week Intervention)
- Patient Health Questionnaire-9(20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively)
研究者
Luciana Macedo
Assistant Professor
McMaster University