Therapeutic Exercise and Education for Low Back Pain

Sponsor
University of Valladolid
Study ID
NCT07713082
Status
Not Yet Recruiting

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Conditions

  • Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Mar 31, 2027
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Online Therapeutic Exercise and Education Group
    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.
  • Experimental: Face-to-Face Therapeutic Exercise and Education Group
    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.
  • Active Comparator: Conventional Treatment Group
    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.

Primary Outcome Measure

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). ]

Central Contacts

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