Therapeutic Exercise and Education for Low Back Pain
ConditionLow Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Valladolid
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Therapeutic Exercise
Other interventionThis intervention consists of applying a therapeutic exercise protocol to the lumbopelvic and abdominal muscles. The included exercises are: * Core: Isometric Dead Bug, Dead Bug Leg Lowering, Contralateral Dead Bug, Dead Bug with Leg Abduction and Straight Arm Drop, Band-Resisted Dead Bug. * Core + Abs: Fire Hydrant, Band-Resisted Fire Hydrant, and Band-Resisted Fire Hydrant on Toes * Quadriceps: Chair squat, air squat, asymmetric chair squat, lunge, and chair squat with heel drive. * Gluteus exercises include sun salutation, single-leg dead foot drag, deadlift, skater (extension, external rotation, and abduction), standing donkey kick, and single-leg deadlift. Exercises will be performed at an effort level of 6-7/10 (rate of perceived exertion), leaving three repetitions in reserve per exercise. Participants will perform four to six sets of 15 repetitions for each exercise, with two sessions conducted per week. Rest periods between sets and exercises will be 1.5 minutes.
Education on the self-management of low back pain
BehavioralParticipants will receive four weekly education sessions on self-management of low back pain during the first four weeks of the intervention. The contents of these sessions will be as follows: * The multifactorial origin of the condition and the natural course of the disease * The consequences of rest and the benefits of movement * Ergonomic adaptations applicable to daily, work, and sports activities * Interpretation of imaging tests in relation to patient functionality.
Usual Care
Other interventionParticipants will receive a total of 16 sessions of usual care, two per week. The interventions included are as follows: * Microwave therapy: 15 minutes at 100 watts, continuous * Transcutaneous electrical nerve stimulation (TENS): 80 Hz, 150 microseconds, 20 minutes * An unsupervised exercise program including mobility, strength, and stretching exercises
Treatment groups
132 Participants
are divided into 3 treatment groupsGroup A: Online Therapeutic Exercise and Education GroupExperimental treatment 2 interventions
Group B: Face-to-Face Therapeutic Exercise and Education GroupExperimental treatment 2 interventions
Group C: Conventional Treatment GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in disability level
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.
Time frame
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).Secondary outcomes
1
Changes in Pain Intensity
The Spanish version of the Numeric Pain Rating Scale (NPRS), which is widely used in populations with low back pain, will be used to assess pain during the last week and pain during movement.
Time frame
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).2
Changes in Activity Avoidance Attitudes
Activity avoidance will be assessed using the Spanish version of the Fear-Avoidance Beliefs Questionnaire (FABQ). The questionnaire consists of 16 items distributed across two subscales: physical activity and work.
Time frame
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).3
Change in Catastrophizing Level
Catastrophizing will be measured using the Spanish version of the Pain Catastrophizing Scale (PCS), which consists of 13 items that assess rumination, magnification, and helplessness. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 52. Higher values reflect greater catastrophizing.
Time frame
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).4
Changes in Self-Efficacy Levels
Self-efficacy and confidence in performing back-related activities will be assessed using the Low Back Activity Confidence Scale (LoBACS). The LoBACS consists of 15 items that cover a wide range of activities commonly experienced by patients. The scale is organized into three subscales: functional self-efficacy (confidence in performing functional activities), self-regulatory self-efficacy (confidence in coping with low back pain), and exercise self-efficacy (ability to overcome barriers to regular exercise). Scores on this scale range from 0 to 100, with higher scores indicating a greater level of self-efficacy.
Time frame
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).Locations
Sponsors and contacts
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University of Valladolid
Lead sponsor
Castilla-León Health Service
Collaborator
Source ClinicalTrials.gov
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