Therapeutic Exercise and Education for Low Back Pain | NCT07713082

NCT07713082

Overview

NCT ID: NCT07713082
Lead Sponsor: University of ValladolidOTHER
Official Title: Therapeutic Exercise and Education for Patients With Non-Specific Low Back Pain in Primary Health Care: A Multicenter Clinical Trial
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Mar 2027Estimated
Primary Completion Date: Dec 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 132Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Héctor Hernández-Lázaro, PhDContact
hector.hernandez.lazaro@uva.es

Similar Studies

Participant Group/Arms

Online Therapeutic Exercise and Education GroupExperimental

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.

Other: Therapeutic Exercise

Behavioral: Education on the self-management of low back pain

Face-to-Face Therapeutic Exercise and Education GroupExperimental

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.

Other: Therapeutic Exercise

Conventional Treatment GroupActive 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.

Other: Usual Care