Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07713082

Therapeutic Exercise and Education for 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic exercise

Other

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 pain

Behavioral

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 Care

Other

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

Primary outcomes

  1. Change in disability level

    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).

    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.

Secondary outcomes

  1. Changes in Pain Intensity

    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).

    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.

  2. Changes in Activity Avoidance Attitudes

    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).

    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.

  3. Change in Catastrophizing Level

    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).

    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.

  4. Changes in Self-Efficacy Levels

    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).

    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.

  5. Changes in Anxiety and Depression

    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).

    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.

  6. Changes in kinesiophobia levels

    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).

    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.

  7. Change in quality of life

    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).

    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.

  8. Changes in Knowledge and Beliefs about Low Back Pain

    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).

    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).

  9. Level of satisfaction with treatment administered

    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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Héctor Hernández-Lázaro, PhD

CONTACT

[email protected]

+34975220850 ext. 38841

Luis Ceballos-Laita, PhD

CONTACT

[email protected]

+34975129100

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Collaborators

  • Castilla-León Health Service

Registry information

Official study title

Therapeutic Exercise and Education for Patients With Non-Specific Low Back Pain in Primary Health Care: A Multicenter Clinical Trial

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.