Therapeutic Exercise and Education for Low Back Pain

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other Therapeutic Exercise
  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 e
• Behavioral Education on the self-management of low back pain
  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.
• Other Usual Care
  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 outcome measures

• 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).]

Secondary outcome measures (9)

• 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).]
• 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).]
• 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).]
• 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).]
• 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).]
• 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).]
• 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).]
• 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).]
• 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).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 34719942
• Delitto 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. PMID 22466247

Identifiers

NCT: NCT07713082 · TEED-LBP-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗