Therapeutic Exercise and Education for Patients With Non-Specific Low Back Pain in Primary Health Care: A Multicenter Clinical Trial
| Registry | NCT07713082 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 132 (Estimated) |
| Sponsor | University of Valladolid (Other); collaborators: Castilla-León Health Service |
| Conditions | Low Back Pain |
| Interventions | Therapeutic Exercise, Education on the self-management of low back pain, Usual Care (Other, behavioral) |
| Dates | start 2027-03-01 (estimated), primary completion 2027-12-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-07-20, last updated 2026-10-20 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Low Back Pain All trials of Therapeutic Exercise All trials of Education on the self-management of low back pain
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.
Study Protocol and Operational Description
1. 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.
2. 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.
3. 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).
Primary Outcome Measure: Functional disability, quantified using the Oswestry Disability Index (ODI).
\- Secondary Outcome Measures: Pain intensity, activity avoidance, pain catastrophizing, kinesiophobia, anxiety and depression symptoms, health-related quality of life, patient beliefs/knowledge regarding low back pain, and overall satisfaction with the intervention.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Online Therapeutic Exercise and Education Group | Experimental | Other: Therapeutic Exercise; Behavioral: Education on the self-management of low back pain | 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. |
| Face-to-Face Therapeutic Exercise and Education Group | Experimental | Other: Therapeutic Exercise; Behavioral: Education on the self-management of low back pain | 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. |
| Conventional Treatment Group | Active comparator | Other: Usual Care | 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. |
Sex: All, ages: 18 Years to any
Inclusion criteria: * 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. Exclusion criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital "Virgen del Mirón". Active Coping Strategies for Pain Unit in Primary Care | Soria | Spain |