Efficacy of Educating Physical Therapists on Clinical Practice Guidelines and Pain Management in the Treatment of Patients With Nonspecific Chronic Low Back Pain: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Pain intensity (Pain NRS)
研究概览
简要总结
The aim of this trial is to investigate if patients treated by physical therapists who received an update on clinical practice guidelines and pain management have better outcomes than patients treated by physical therapists who did not received such training.
详细描述
The training "Update on the treatment of patients with nonspecific chronic low back pain" will be announced in the social network by members of the study. Interested physical therapists will send an email to one of the study authors with their information regarding the inclusion criteria. After two months of notice, interested and eligible physiotherapists will be randomized into two groups of 15 participants each.
The study arms are: 1) control group (physical therapist who will not receive training) and 2) experimental group (physical therapist who will receive training). Before and after training, attitudes, beliefs and knowledge about low back pain guidelines will be evaluated.
Each physical therapist will recruit for the study a total of fifteen consecutive patients with chronic nonspecific low back pain (total sample=150 patients). All the patients will be assessed before the first session by a blinded examiner who will be unaware about the group allocation.
Clinical outcomes (pain, disability, fear avoidance beliefs and pain catastrophizing) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 pain numerical rating scale, aged between 18 and 65 years.
- •physiotherapists who treat exclusively patients with musculoskeletal pain, duly accredited by the National Council of Physical Therapy, physiotherapists offering private or medical insurance treatment individually to their patients, lasting 50-60 minutes each session, physiotherapists from 2 to five years of graduation and / or working in the area for the same period, that treat at least 2 patients with low back pain per month, and who are willing to treat at least 10 patients for the study.
排除标准
- •patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy.
- •physiotherapists who want to stop the activities for some reason that prevents participation in the study
研究组 & 干预措施
Untrained Physical Therapists
The patients allocated to the Control group will be treated by physical therapists who did not receive any training about clinical practice guidelines and pain management. These patients will receive the usual care from their physical therapists.
干预措施: Control (Other)
Trained Physical Therapists
The patients allocated to the Experimental group will be treated by physical therapists who received training about clinical practice guidelines and pain management.
干预措施: Trained (Other)
结局指标
主要结局
Pain intensity (Pain NRS)
时间窗: 5 weeks after randomization
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability (24-item Roland Morris Disability Questionnaire)
时间窗: 5 weeks after randomization
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
次要结局
- Pain intensity (Pain NRS)(3 and 6 months after randomization)
- Disability ( 24-item Roland Morris Disability Questionnaire)(3 and 6 months after randomization)
- Fear Avoidance Beliefs (FABQ)(5 weeks, 3 months and 6 months after randomization)
- Pain Catastrophizing (PCS)(5 weeks, 3 months and 6 months after randomization)
研究者
Rodrigo Rossi Nogueira Rizzo
Masters student
Universidade Cidade de Sao Paulo