Self-Selected Versus Physiotherapist-Prescribed Resistance Training Program In People With Chronic Low Back Pain

Официальное название

Efficacy of a Self-Selected Resistance Training Program Compared With a Physiotherapist-Prescribed Resistance Training Program in People With Chronic Low Back Pain (MyBack Exercise): A Randomized Control Pilot Study

Обзор

Chronic low back pain is a public health issue affecting over 20% of the Spanish population, causing disability, reduced quality of life, and work absenteeism. Over the past decades, the benefits of physical exercise for improving symptoms in patients with chronic low back pain have been studied. Exercise has also been shown to improve quality of life, general health, self-efficacy, and fear of pain, regardless of pathology. Research on the effect of physical exercise in chronic low back pain patients has shown promising results. Therefore, the therapeutic exercise program proposed in this study may help participants adopt healthy habits that positively impact their quality of life. This will be a clinical trial in patients with chronic low back pain. The main purpose of the study is to evaluate the efficacy of a self-selected resistance training program versus physiotherapist-prescribed exercises in improving pain intensity and disability in adults with chronic low back pain. Secondary objectives include evaluating differences between the two groups after 12 weeks in treatment satisfaction, degree of compliance, kinesiophobia, self-efficacy, muscle endurance, and lumbar electromyographic activity. If you agree to participate, a member of the research team experienced in exercise programs for chronic low back pain will instruct you on how to perform the program. The follow-up study will include 34 participants randomly assigned to two groups: one group performing self-selected resistance exercises, and one group performing physiotherapist-prescribed exercises. The study will last 12 weeks, assessing your condition at the start and end of the study. You will complete questionnaires on pain intensity (Numerical Pain Rating Scale, NPRS), disability (Oswestry Disability Index, ODI), treatment satisfaction (CRES-4), adherence to treatment, kinesiophobia (TSK-11), self-efficacy (Pain Self-Efficacy Questionnaire, PSEQ), muscle endurance (Biering-Sørensen test), and surface electromyographic activity of the erector spinae (longissimus) muscle (sEMG-ESL) using the mDurance® device. POTENTIAL BENEFITS AND RISKS OF PARTICIPATION Expected direct benefits of participation may include improvements in pain intensity, disability, treatment satisfaction, adherence to therapeutic exercise, kinesiophobia, self-efficacy, muscle endurance, and electromyographic activity. However, it is possible that you may not experience any personal benefit. The information obtained will contribute to scientific knowledge about CLBP and may help others in the future. ALTERNATIVE TREATMENTS Chronic low back pain is a pathological entity with extensive study, which can present different conservative therapeutic options, such as psychological therapy, regular physical exercise and the adoption of healthy habits. COMPENSATION Participation in this study will not incur any costs for you. OTHER RELEVANT INFORMATION Any new information discovered during your participation that may affect your willingness to participate in the study will be communicated to you by your doctor as soon as possible. If you decide to withdraw your consent to participate in this study, no new data will be added to the database, and if samples have already been collected, you may request the destruction of all previously obtained, identifiable samples to avoid further analysis. You should also be aware that you may be excluded from the study if the sponsor or researchers deem it necessary, either for safety reasons or because they believe you are not complying with the established procedures. In either case, you will receive a clear explanation of the reason for your withdrawal from the study. The sponsor may suspend the study for any of the reasons stipulated in current legislation. By signing the attached consent form, you agree to comply with the study procedures explained to you. When your participation is over, you will receive the best available treatment that your doctor considers most appropriate for your condition.

Вмешательства

• Поведенческое Control group
  The control group will carry out a physiotherapist-prescribed RT programme. Participants in this group will not be able to choose their exercises and will perform six exercises: push-ups, row, squat, deadlift, abdominal crunch and back extension.
• Поведенческое Experimental group
  The experimental group will follow a programme with different RT options. This proposal will be displayed on a board with detailed images of the exercises in the treatment centre. Each patient will individually choose six exercises daily; two for each body part (upper limb; lower limb; trunk). Each patient's individual choice of exercises will be recorded using checklists. Under no circumstances will the physiotherapist guidance take precedence; the clinician will refrain from expressing their p

Первичные конечные точки

• Pain-related distribution and intensity [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Disability [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (6)

• Treatment satisfaction [Срок оценки: From T1 (4 weeks) to the end of treatment at 12 weeks]
• Degree of compliance [Срок оценки: From T1 (4 weeks) to the end of treatment at 12 weeks]
• Kinesiophobia [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Self-efficacy [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Muscle endurance [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Surface electromyographic activity of the erector spinae (longissimus) muscle (sEMG-ESL) [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

a) Male and female participants aged 18-65 years b) Low back pain, with or without referred pain to the lower limb, persisting for ≥12 weeks c) Not currently engaged in a regular structured exercise programme d) Sufficient cognitive and communication abilities to complete the assessment scales and participate in the study intervention Exclusion Criteria

• Lumbar radiculopathy or radicular pain syndrome, defined by clinical signs of nerve root involvement (e.g., dermatomal pain, neurological deficits, or positive neurodynamic tests)
• Serious spinal or non-spinal pathology explaining low back pain, identified through clinical assessment (e.g., malignancy, vertebral fracture, spinal infection, cauda equina syndrome, inflammatory spinal disease, vascular, visceral or other serious causes).
• Medical contraindications to exercise, as determined by the treating physician The presence of lumbar degenerative imaging findings (e.g., degenerative disc disease, lumbar spondylosis, facet joint osteoarthritis, or Modic changes) will not constitute an exclusion criterion, provided that the clinical presentation is consistent with chronic low back pain.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07745465 · 2026-0301-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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