Therapeutic Exercise and Education for Patients With Non-Specific Low Back Pain in Primary Health Care: A Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 主要终点
- Change in disability level
研究概览
简要总结
This study will evaluate a new treatment program for patients with ongoing or long-term low back pain who receive care at primary care physiotherapy units. Participants with subacute or chronic nonspecific low back pain will be randomly divided into three groups for comparison of their progress. The first group will receive an eight-week program of therapeutic exercise and health education, which will be delivered entirely online. The second group will receive the same exercise and education program in face-to-face sessions. The third group will receive standard physiotherapy care. The study will last eight weeks, and researchers will follow up with participants three months later. The project's main goal is to measure changes in participants' daily disability levels. The researchers will also examine other important factors, such as pain intensity, fear of movement, anxiety, depression, quality of life, and overall satisfaction with the care received. Measurements will be taken before the study begins, immediately after the eight-week program ends, and at the three-month follow-up. This trial aims to find more accessible, evidence-based ways to treat back pain, reduce hospital waiting lists, and improve patient well-being by combining digital and in-person care.
详细描述
Study Protocol and Operational Description
- Rationale and Study Justification Despite updated clinical guidelines that prioritize active interventions, such as therapeutic exercise and pain education, these interventions are not widely implemented in primary care settings. The discrepancy between evidence and practice presents a clear opportunity for improvement. Adopting structured programs based on scientific evidence promotes a consistent, efficient approach aligned with the biopsychosocial model. Consequently, this clinical trial aims to generate high-quality evidence in the primary care context to evaluate the effectiveness and efficiency of these care models. This will facilitate their implementation and advance us toward a more accessible and sustainable healthcare system.
- Study Design and Randomization This multicenter, randomized, single-blind, controlled clinical trial has a three-arm parallel group design. After recruitment at the Primary Care Physiotherapy Units (PCPUs) of the Castilla y León Health Service (SACYL) and informed consent is signed, participants with subacute or chronic nonspecific low back pain will be randomly assigned to one of three study groups.
- Description of the Intervention Arms All active intervention protocols will be carried out over a period of eight weeks.
Online Therapeutic Exercise and Education (ETEO): Participants will engage in an eight-week, home-based therapeutic exercise program combined with pain neuroscience education. All content, instructional materials, and compliance monitoring will be delivered via a dedicated digital platform.
Face-to-Face Therapeutic Exercise and Education (ETEP): Participants will receive the same 8-week exercise and education curriculum through in-person, group sessions at participating PCPUs.
Conventional Treatment (CT): Participants will receive standard physiotherapy care as routinely provided within the public regional health service framework. 4. Assessment Timeline and Outcome Measures Blinded evaluators will perform data collection and clinical measurements at three specific time points: baseline (T0), immediately post-intervention at eight weeks (T1), and at the three-month long-term follow-up (T2).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-specific low back pain, aged 18 years or older.
- •Pain duration of more than six weeks
- •Onset or modification of low back pain with maintenance of positions and/or movements
- •Presenting a mild-to-moderate level of disability, as determined by the Oswestry Disability Index (ODI) questionnaire.
- •Presence of limitations or symptoms in at least two range of motion (ROM) or coordination assessment tests, as described in clinical guidelines:
- •Lumbar and/or hip range of motion (ROM) measured with inclinometry Prone instability test
- •Presence of aberrant movements:
- •Painful arc with flexion or return from flexion
- •Instability catch
- •Gower sign
- •Reversal of lumbopelvic rhythm
- •Strength and endurance of the abdominal musculature
- •Email access and a device with an internet connection are required.
- •Availability and willingness to participate in all study sessions.
排除标准
- •Presence of acute, nociplastic, radicular, and/or referred pain
- •Presence of red flags
- •Previous surgeries in the spine, pelvis, or hip
- •Presence of concomitant cardiovascular, neurological, endocrine, or immune pathologies that prevent physical activity
- •Presence of psychiatric disorders
- •Pregnancy
- •Having received physiotherapy treatment, analgesic blocks, corticosteroid injections, or any other type of intervention within the last three months
- •Changes in lifestyle habits, work conditions, or physical activity levels within the last three months
- •Inability to meet the program's physical or cognitive demands during the eight weeks
研究组 & 干预措施
Online Therapeutic Exercise and Education Group
Participants will carry out an eight-week protocol consisting of education on managing the condition and therapeutic exercises for the lumbopelvic and abdominal muscles. This will be performed progressively. All exercises will be performed at a perceived exertion level of 6-7 out of 10, leaving approximately three repetitions in reserve per exercise. If exertion values are lower, the exercise intensity will increase. If the intensity exceeds 7, the exercise intensity will decrease. Elastic bands and exercise variations will be used to achieve this. Rest periods between sets and exercises will be 1.5 minutes. These sessions will be carried out synchronously online using the Google Meets platform. This allows the physiotherapist to supervise and guide four to six participants per group online.
干预措施: Therapeutic Exercise (Other)
Online Therapeutic Exercise and Education Group
Participants will carry out an eight-week protocol consisting of education on managing the condition and therapeutic exercises for the lumbopelvic and abdominal muscles. This will be performed progressively. All exercises will be performed at a perceived exertion level of 6-7 out of 10, leaving approximately three repetitions in reserve per exercise. If exertion values are lower, the exercise intensity will increase. If the intensity exceeds 7, the exercise intensity will decrease. Elastic bands and exercise variations will be used to achieve this. Rest periods between sets and exercises will be 1.5 minutes. These sessions will be carried out synchronously online using the Google Meets platform. This allows the physiotherapist to supervise and guide four to six participants per group online.
干预措施: Education on the self-management of low back pain (Behavioral)
Face-to-Face Therapeutic Exercise and Education Group
This group will receive the same educational protocol for condition management and therapeutic exercise as the previous one, but it will be carried out in a face-to-face group format supervised by a physiotherapist from the Primary Care Physiotherapy Units.
干预措施: Therapeutic Exercise (Other)
Face-to-Face Therapeutic Exercise and Education Group
This group will receive the same educational protocol for condition management and therapeutic exercise as the previous one, but it will be carried out in a face-to-face group format supervised by a physiotherapist from the Primary Care Physiotherapy Units.
干预措施: Education on the self-management of low back pain (Behavioral)
Conventional Treatment Group
This group will undergo interventions typically applied in primary care physiotherapy units, including electrotherapy and exercise training. The following electrotherapy techniques will be applied:
- Microwave therapy: 15 minutes at 100 watts, continuous TENS: 80 Hz, 150 microseconds, 20 minutes. Regarding exercises, a general program incorporating mobility, strength, and stretching work will be included. The physiotherapist will explain the program during the first treatment session, after which the patient will perform the exercises independently in subsequent sessions. During these sessions, patients will receive a sheet with a complete list of exercises and their explanations. They will also have the opportunity to consult the physiotherapist if they have any questions.
干预措施: Usual Care (Other)
结局指标
主要结局
Change in disability level
时间窗: From study enrollment through the end of treatment (8 weeks) and follow-up (12 weeks after the end of treatment)
Functional disability will be measured using the Spanish version of the Oswestry Disability Index (ODI). This questionnaire consists of 10 items with 6 response options each (0-5 points), which assess limitations in activities of daily living.
Change in disability level
时间窗: From the time of enrollment in the study through the end of treatment (eight weeks) and the follow-up period (12 weeks after the end of treatment).
Functional disability will be measured using the Spanish version of the Oswestry Disability Index (ODI). The ODI is a 10-item questionnaire with six response options each (0-5 points) that assess limitations in activities of daily living.
次要结局
- Changes in pain intensity(From study enrollment through the end of treatment (8 weeks) and follow-up (12 weeks after the end of treatment))
- Changes in activity avoidance attitudes(From study enrollment through the end of treatment (8 weeks) and follow-up (12 weeks after the end of treatment))
- Change in catastrophizing level(From study enrollment through the end of treatment (8 weeks) and follow-up (12 weeks after the end of treatment))
- Changes in self-efficacy levels(From study enrollment through the end of treatment (8 weeks) and follow-up (12 weeks after the end of treatment))
- Changes in anxiety and depression(From study enrollment through the end of treatment (8 weeks) and follow-up (12 weeks after the end of treatment))
- Changes in kinesiophobia levels(From study enrollment through the end of treatment (8 weeks) and follow-up (12 weeks after the end of treatment))
- Change in quality of life(From study enrollment through the end of treatment (8 weeks) and follow-up (12 weeks after the end of treatment))
- Changes in the knowledge and beliefs about low back pain(From study enrollment through the end of treatment (8 weeks) and follow-up (12 weeks after the end of treatment))
- Level of satisfaction with the treatment administered(From study enrollment through the end of treatment (8 weeks) and follow-up (12 weeks after the end of treatment))
- Changes in Pain Intensity(From the time of enrollment in the study through the end of treatment (eight weeks) and the follow-up period (12 weeks after the end of treatment).)
- Changes in Activity Avoidance Attitudes(From the time of enrollment in the study through the end of treatment (eight weeks) and the follow-up period (12 weeks after the end of treatment).)
- Change in Catastrophizing Level(From the time of enrollment in the study through the end of treatment (eight weeks) and the follow-up period (12 weeks after the end of treatment).)
- Changes in Self-Efficacy Levels(From the time of enrollment in the study through the end of treatment (eight weeks) and the follow-up period (12 weeks after the end of treatment).)
- Changes in Anxiety and Depression(From the time of enrollment in the study through the end of treatment (eight weeks) and the follow-up period (12 weeks after the end of treatment).)
- Changes in kinesiophobia levels(From the time of enrollment in the study through the end of treatment (eight weeks) and the follow-up period (12 weeks after the end of treatment).)
- Change in quality of life(From the time of enrollment in the study through the end of treatment (eight weeks) and the follow-up period (12 weeks after the end of treatment).)
- Changes in Knowledge and Beliefs about Low Back Pain(From the time of enrollment in the study through the end of treatment (eight weeks) and the follow-up period (12 weeks after the end of treatment).)
- Level of satisfaction with treatment administered(From the time of enrollment in the study through the end of treatment (eight weeks) and the follow-up period (12 weeks after the end of treatment).)
研究者
Héctor Hernández Lázaro
Associate Professor
University of Valladolid