Therapeutic Exercise and Education for Low Back Pain
1 other identifier
interventional
132
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Mar 2027
Typical duration for not_applicable low-back-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2026
CompletedFirst Posted
Study publicly available on registry
July 20, 2026
CompletedStudy Start
First participant enrolled
March 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
Study Completion
Last participant's last visit for all outcomes
September 1, 2028
July 21, 2026
July 1, 2026
9 months
July 14, 2026
July 17, 2026
Conditions
Keywords
Outcome Measures
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.
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
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
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
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
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
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 more secondary outcomes
Study Arms (3)
Online Therapeutic Exercise and Education Group
EXPERIMENTALParticipants 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.
Face-to-Face Therapeutic Exercise and Education Group
EXPERIMENTALThis 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.
Conventional Treatment Group
ACTIVE COMPARATORThis 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.
Interventions
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 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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Valladolidlead
- Castilla-León Health Servicecollaborator
Related Publications (2)
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: 34719942BACKGROUNDDelitto 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: 22466247BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 14, 2026
First Posted
July 20, 2026
Study Start (Estimated)
March 1, 2027
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
September 1, 2028
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share