MyBack - Effectiveness and Implementation of a Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences: a Hybrid Effectiveness-implementation Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Risk of low back pain recurrence
研究概览
简要总结
Low Back Pain is a common heath condition with high rates of recurrence and huge associated costs. Research has focused its efforts on analysing the effects of interventions while knowledge about effective secondary prevention strategies is limited. MyBack study aims to analyse the effectiveness of a tailored exercise and behavioural change program (MyBack program) in the secondary prevention of low back pain, and evaluate acceptability, feasibility and determinants of implementation by the different stakeholders, as well as the implementation strategy of the MyBack program, through a hybrid type I, randomized, controlled and multicentre study of effectiveness and implementation in the context of primary health care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- 是
入选标准
- •Recovered (within the last 3 months) from an episode of non-specific LBP (with or without leg pain and of any duration)
- •Recovery from an LBP episode is defined as having a pain score of "0" or "1" on a 11-point Numeric Pain Rating Scale for, at least, 30 consecutive days
- •Age between 18 and 65 years;
- •Read and speak the Portuguese language;
- •Having a mobile phone capable of receiving and sending text messages;
- •No medical contraindication to exercise.
排除标准
- •Diagnosis, or symptoms consistent with, severe depression or other psychiatric condition,
- •Pregnancy
- •Spinal surgery in the last 6 months
研究组 & 干预措施
Usual Care
Participants allocated to the usual care group will be informed that they can access their GP in the usual way (GPs consultation, pain medication, referral for other treatments/ services) and that they should contact their GP if their condition worsens. In addition, they will receive a minimal educational intervention focused on symptom management and promotion of physical activity ("stay active").
干预措施: Usual Care (Other)
MyBack
Patients in the MyBack group will participate in a patient-centred, tailored exercise programme informed by a behavioural change approach in addition to receiving usual care. The MyBack intervention programme will consist of 12 bi-weekly sessions (60 minutes each) over 6 weeks complemented by 12 exercise sessions to be carried out autonomously by the participants over the following 6 weeks
干预措施: Usual Care (Other)
MyBack
Patients in the MyBack group will participate in a patient-centred, tailored exercise programme informed by a behavioural change approach in addition to receiving usual care. The MyBack intervention programme will consist of 12 bi-weekly sessions (60 minutes each) over 6 weeks complemented by 12 exercise sessions to be carried out autonomously by the participants over the following 6 weeks
干预措施: MyBack Program (Other)
结局指标
主要结局
Risk of low back pain recurrence
时间窗: 12 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 1 month after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 2 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 3 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 4 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 5 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 6 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 7 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 8 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 9 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 10 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
时间窗: 11 months after baseline
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
次要结局
- Pain intensity(Baseline, 3, 6 and 12 months after baseline)
- Functional Disability(Baseline, 3, 6 and 12 months after baseline)
- Musculoskeletal Health(Baseline, 3, 6 and 12 months after baseline)
- Health-related quality of life(Baseline, 3, 6 and 12 months after baseline)
- Medical appointments for a low back pain recurrence(3, 6, 9 and 12 months after baseline)
- Imaging tests prescribed related with a low back pain recurrence(3, 6, 9 and 12 months after baseline)
- Pain medication for low back pain recurrence(3, 6, 9 and 12 months after baseline)
- Referral to other interventions and sickness certificates(3, 6, 9 and 12 months after baseline)
- Impact of LBP recurrence(12 months after baseline)
- Impact of LBP recurrence(1 month after baseline)
- Impact of LBP recurrence(2 months after baseline)
- Impact of LBP recurrence(3 months after baseline)
- Impact of LBP recurrence(4 months after baseline)
- Impact of LBP recurrence(5 months after baseline)
- Impact of LBP recurrence(6 months after baseline)
- Impact of LBP recurrence(7 months after baseline)
- Impact of LBP recurrence(8 months after baseline)
- Impact of LBP recurrence(9 months after baseline)
- Impact of LBP recurrence(10 months after baseline)
- Impact of LBP recurrence(11 months after baseline)
研究者
Eduardo B. Cruz
Professor
Instituto Politécnico de Setúbal