An interventional study of Therapeutic Exercise and Education on the self-management of low back pain in Low Back Pain, sponsored by University of Valladolid. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University of Valladolid · Not applicable, Interventional, and Treatment
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
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.
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 132 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University of Valladolid is the lead sponsor of 34 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of aberrant movements:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Other: Therapeutic Exercise · Behavioral: Education on the self-management of low back pain
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.
Other: Usual Care
This 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.
Participants 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.
Participants 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
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).
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).
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).
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).
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).
Changes in Anxiety and Depression
Anxiety and depression will be assessed using the Spanish version of the Hospital Anxiety and Depression Scale (HADS), which has 14 items divided into two subscales: anxiety and depression. Each item is scored from 0 to 3, and the total possible score per subscale is 21. Higher scores indicate greater symptomatology.
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).
Changes in kinesiophobia levels
Kinesiophobia will be measured using the Spanish version of the 11-item Tampa Scale for Kinesiophobia (TSK-11). Each item is scored on a Likert scale from 1 to 4. The total score ranges from 11 to 44; higher values indicate a greater fear of 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).
Change in quality of life
Health-related quality of life will be assessed using the Spanish version of the EuroQol-5D (EQ-5D). The EQ-5D includes five dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression - with different levels of severity. It also includes a visual analog scale (VAS) ranging from 0 to 100. The utility index is calculated based on the responses provided, with higher values indicating a better health status.
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).
Changes in Knowledge and Beliefs about Low Back Pain
The Back Pain Knowledge and Beliefs Survey (BacKS) will be used to assess knowledge and beliefs about low back pain. BacKS is a patient-reported outcome measure designed to evaluate the level of evidence-based knowledge and beliefs associated with low back pain. The survey consists of 20 items scored on a Likert scale from 1 to 5, where 1 corresponds to "strongly disagree" and 5 corresponds to "strongly agree." Total scores range from 20 to 100; higher scores indicate greater knowledge and beliefs aligned with scientific evidence. The questionnaire has a two-dimensional structure, with one factor related to biomedical knowledge (nine items) and another related to self-care knowledge (11 items).
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).
Level of satisfaction with treatment administered
Overall perception of change will be assessed using the Global Rating of Change (GROC) in the version used for the Spanish population. The GROC is an ordinal scale that typically ranges from negative values (worsening) to positive values (improvement), with a neutral point (no change). The score reflects the patient's perception of their clinical evolution.
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).
Plan to share: No
Start is estimated for Mar 2027; primary completion for Dec 2027, 9 months later.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 9 months is below that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Valladolid