Feasibility and Effect of a Multidisciplinary Telematics Approach for Chronic Non-specific Low Back Pain: a Randomized, Open-label, Controlled, Pilot Clinical Trial. Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of scheduled visits attended
研究概览
简要总结
Low back pain is a challenging condition, with a lifetime prevalence of up to 84%. The estimated prevalence of chronic non-specific low back pain is of approximately 23%. Although pain is a sensory experience triggered by a peripheral stimulus, psychosocial factors influence on its perception and on the risk of chronification.
Chronic Low Back Pain imposes a substantial socioeconomic burden to patients, families, and healthcare systems worldwide. It is a multifactorial condition, characterized by a combination of physical, psychosocial and occupational factors. We have planned two working hypotheses: (1) coordinating several healthcare professionals is feasible to manage chronic non-specific low back pain through telematics multidisciplinary approach; (2) telematics multidisciplinary approach improves the quality of life of patients with chronic non-specific low back pain and in whom conservative treatment has failed. Hence, we aim to assess the feasibility and effect of telematics multidisciplinary approach in patients suffering from chronic non-specific low back pain and who have not improved with conservative treatment.
Patients will be randomized to the telematics multidisciplinary approach (Experimental Group) or to the Standard of Care (Control Group). Scheduled and periodic telematics multidisciplinary sessions will be performed. Each session will consist of an integrated program that combines rehabilitation (i.e., group-based exercise program), psychological treatment and social work sessions. Standard of Care, after conservative treatment failure, depends mainly on the physician in charge's discretion and on the patients' preferences. An exploratory analysis will be performed.
The results of this clinical trial will provide evidence that a scheduled telematics multidisciplinary approach will improve the quality of life of these patients and empower them to be more autonomous. Likewise, telematics multidisciplinary approach is feasible to manage chronic non-specific low back pain in patients unresponsive to conservative treatment. Consequently, these patients are less likely to wander through different medical specialties seeking for a solution to their condition, presumably avoiding ineffective back surgeries. The results will also highlight the importance of patients playing an active role in their own treatment to successfully manage chronic non-specific low back pain.
详细描述
Objectives {#7}:
Hypothesis:
Two working hypothesis have been planned: i) the coordination of several health care professionals is feasible to manage CnsLBP (Chronic non-specific Low Back Pain) through telematics multidisciplinary approach; ii) telematics multidisciplinary approach improves the quality of life of patients who suffer from CnsLBP and in whom conservative treatment has failed
Primary Objective The primary aims are to assess the feasibility and effect of the telematics multidisciplinary approach in patients who suffer from non-specific CnsLBP and in whom conservative treatment has failed.
Secondary objectives
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
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria {#10}:
- •Inclusion Criteria:
- •Patients between 18 and 67 years of age (i.e., working age population).
- •Both genders.
- •Patients with chronic non-specific low back pain that does not improve with conservative treatment (including rehabilitation and Pain Clinic evaluation and follow-up).
- •The predominant symptom must be low back pain (and not pain radiating to the extremities).
- •Patients who sign the informed consent form
排除标准
- •Patients who have previously undergone lumbar arthrodesis.
- •Patients diagnosed with lumbar instability or non-degenerative pathologies (fractures, tumors, infections, etc.) that justify their chronic low back pain.
- •Patients who cannot move independently.
- •Patients who have a contraindication to perform light aerobic exercise or physical therapy exercises for the treatment of low back pain.
- •Patients with a psychiatric history that interferes with their daily life
- •Patients who are possible candidates for low back surgery, with a planned intervention during the study period.
- •Patients who have a programmed Pain Clinic intervention or extra rehabilitation sessions scheduled during the study period.
- •Patients who lack motivation or show no commitment to the program.
- •Patients who do not have access to a device with internet connection and/or to a webcam (smartphone, tablet, or computer).
- •Note: Since this is a pilot clinical trial with a small sample size, patients who receive extra sessions of rehabilitation or interventions in Pain Clinic will be withdrawn from the study to minimize the impact on the results, although these treatments are also part of the SoC.
结局指标
主要结局
Number of scheduled visits attended
时间窗: 6 months
Number of visits attended by the patients out of the total of scheduled visits
Number of questionnaires fulfilled
时间窗: 6 months
Number of questionnaires fulfilled by the patients out of the total scheduled questionnaires
Number of telematics multidisciplinary sessions attended
时间窗: 6 months
Number of telematics multidisciplinary sessions attended by the patients out of the total scheduled sessions
Number of withdrawals
时间窗: 6 months
Number of withdrawals out of the total patients enrolled in the study
Number of sessions performed out of the 8 sessions scheduled
时间窗: 6 months
number of telematics multidisciplinary sessions performed out of the 8 sessions scheduled acording the study protocol
次要结局
- SF-36 (Short Form-36) total punctuation(6 months)
研究者
Iago Garreta Catala
Consultant of Orthopaedics Surgery, Principal Investigator
Hospital Universitari de Bellvitge