Low Back PainNCT07713082
Therapeutic Exercise and Education for Low Back Pain
A study testing Therapeutic Exercise and Education on the self-management of low back pain in people with Low Back Pain, run by University of Valladolid at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Therapeutic Exercise and Education on the self-management of low back pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2027to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital "Virgen del Mirón". Active Coping Strategies for Pain Unit in Primary Care
Soria, 42005
Héctor Hernández Lázaro, PT, PhD, +34975220850 ext. 38841, hector.hernandez.lazaro@uva.es
About this study
Official title: Therapeutic Exercise and Education for Patients With Non-Specific Low Back Pain in Primary Health Care: A Multicenter Clinical 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.
Read the detailed description
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.
- 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.
- Conditions
- Low Back Pain
- Being tested
- Therapeutic Exercise, Education on the self-management of low back pain, Usual Care
- Keywords
- low back pain, therapeutic exercise, pain education, primary health care, randomized controlled trial
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ExerciseOther
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.
Education on the self-management of low back painBehavioural
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.
Usual CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| Online Therapeutic Exercise and Education Group | Experimental | 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. Receives: Other: Therapeutic Exercise; Behavioral: Education on the self-management of low back pain |
| Face-to-Face Therapeutic Exercise and Education Group | Experimental | 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. Receives: Other: Therapeutic Exercise; Behavioral: Education on the self-management of low back pain |
| Conventional Treatment Group | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startMar 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service
- Responsible party
- Principal investigator, Héctor Hernández Lázaro, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713082
- Sponsor's protocol ID
- CEIm 3643
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
PubMed 34719942Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
PubMed 22466247