Behavioral Activation and Exercise Protocol for Chronic Pain Patients Based on the Use of New Technologies (Smartphone)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Cognitive functioning assessment.
研究概览
简要总结
Chronic pain of moderate to severe intensity occurs in 19% of adult Europeans. Non-specific low-back pain is one of the most prevalent symptoms and the main cause of disability in industrialized countries, generating significant public health expenditure on health and occupational care. The combination of pain neurophysiology education and therapeutic exercise has shown positive effects in patients with chronic non-specific low back pain. Mobile health tools (mHealth) are proposed as a cost-effective alternative to continuously record the daily activities of patients and to provide rapid feedback to users and clinicians, reducing visits to clinics. A 4-week (8-session) education and exercise-based intervention will be carried out in a group of patients with non-specific chronic low back pain using two modalities: (1) face-to-face guided by a health professional or (2) self-managed through BackFit App. The sample will be divided into two groups and will be evaluated before (pre), after (post) and 3 months (follow-up) after the intervention.
详细描述
The objectives of this study are:
- To assess the influence of a 4-week (8 sessions) intervention based on education (about pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility, and self-massage) on pressure pain thresholds (PPT) and cognitive functioning (selective attention), as primary variable outcomes, and on physical condition (balance and range of movement), affective and cognitive symptoms (mood, anxiety, catastrophizing, fear-avoidance beliefs and kinesiophobia), pain interference and self-reported clinical pain, as secondary variable outcomes, in patients with non-specific chronic low back pain.
- To evaluate the effectiveness of a mobile health application developed by researchers (BackFit App) to carry out the intervention, in comparison with a supervised intervention by a health professional.
The hypotheses of the study are:
- This intervention based on education and physical exercise will increase PPT and improve selective attention.
- This intervention will also improve physical condition, self-reported clinical pain, affective and cognitive symptoms and pain interference presented by patients with chronic low back pain.
- The intervention performed with BackFit App will be as effective as that supervised by a health professional.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 18 and 59 years, with non-specific low back pain for more than 6 weeks and which have experienced at least 3 episodes of low back pain lasting more than 1 week during the year prior to the study, and, at the time of evaluation and/or intervention, presenting pain of mild/moderate intensity (not exceeding 5 out of 10 in a Visual Analogue Scale (VAS)).
排除标准
- •High functional impairment compromising activities such as walking, sitting or getting up from a chair.
- •Pain at the time of evaluation and/or intervention greater than 5 (out of 10) in a VAS.
- •Presence of irradiated pain (sciatic type) or referred to lower extremities.
- •History of spine surgery, spinal or pelvic fracture
- •Hospitalization for serious trauma or injuries due to traffic accidents.
- •History of osteoarthritis in the lower extremities.
- •History of any systematic diseases with involvement of the locomotor system.
结局指标
主要结局
Cognitive functioning assessment.
时间窗: Up to 4 weeks.
Cognitive functioning was assessed by recording electroencephalographic activity during a computerized version of the Flanker task, which measures selective attention, under two experimental conditions: congruent flanks (arrows) with the target (pointing in the same direction as the central arrow) and incongruent (pointing the opposite direction).Regarding Resting EEG a Fast Fourier Transform (FFT) analysis has been made (delta, theta, "Alpha" and beta 1, 2 and 3. The EEG during the "Flanker task" was analyzed by means of a "Cluster-based analysis". Primary outcome measures were recorded in a counterbalanced order and were measured at baseline and 4 weeks.
Heart Rate Variability (HRV)
时间窗: Up to 4 weeks.
Heart Rate Variability (HRV) has been analyzed from ECG data. Primary outcome Measures were recorded in a counterbalanced order and were measured at baseline and 4 weeks.
Pressure pain thresholds (PPT).
时间窗: Up to 12 weeks.
To evaluate Pressure pain thresholds (PPT )(with a maximum of 5kg/cm2) will be applied pressure on the erector spinae and index finger with an algometer (area 1cm2). Primary outcome measures were recorded in a counterbalanced order and were measured at baseline, 4 and 12 weeks.
次要结局
- Clinical pain(Up to 12 weeks.)
- Pain interference(Up to 12 weeks.)
- Balance(Up to 12 weeks.)
- Affective symptoms (Mood)(Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks)
- Affective symptoms (anxiety)(Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks)
- Cognitive symptoms (catastrophizing)(Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks)
- Cognitive symptoms (fear-avoidance beliefs)(Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks)
- Range of movement(Up to 12 weeks.)
- Cognitive symptoms (kinesiophobia)(Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks)