Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain

Официальное название

Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain (PAINDOC Protocol): Randomized, Parallel-group, Two-arm, Single-blind Clinical Trial (PAINDOC Project)

Обзор

PAINDOC is a treatment program that includes 4 disciplines that, separately, have demonstrated their effectiveness in the treatment of chronic low back pain: education in pain neuroscience, therapeutic education (Empowered Relief®), psychotherapy based on cognitive-behavioral therapy and therapeutic exercise. The primary objective of the study is to evaluate the effectiveness of the PAINDOC multidisciplinary treatment program in reducing pain intensity and improving quality of life in persons with chronic low back pain referred to the pain unit of the Hospital Clinic of Barcelona, compared to usual care treatment. As secondary objectives, the present study aims to evaluate the effect of the PAINDOC program on: * The reduction of pain-related disability. * The reduction of pain catastrophizing. * The improvement in perceived social support. * The improvement in perceived autonomy (self-efficacy). * The reduction of analgesic, anti-inflammatory and adjuvant analgesic medication. The main questions it aims to answer are: * Is the proposed multidisciplinary treatment effective in improving pain-related outcomes? * Is the proposed multidisciplinary treatment effective in reducing analgesic medication? Participants will receive either usual care (pharmacological control) or the PAINDOC program, which consists of 7 multidisciplinary sessions within 2 months. There will be one therapeutic education session called Empowered Relief®, 2 pain neuroscience education sessions, one pain psychology session and 3 therapeutic education sessions. Besides, participants will be assessed using written questionnaires before treatment, at 3 months and at 6 months. Researchers will assess the effectiveness of the multidisciplinary treatment group comparing both groups to see if there is any difference in several pain-related outcomes.

Подробное описание

Despite improving pharmacological and surgical medical treatment options, chronic low back pain is the most frequent pain disorder and a leading cause of disability. Over the past decades, clinicians have acknowledged that a broader view of disease and disability is needed in chronic conditions treatment. Therefore, biological, psychological and social factors must be addressed to improve such conditions.

Вмешательства

• Поведенческое Multidisciplinary and multimodal intervention
  The PAINDOC Program consists in: * Therapeutic education: The therapeutic education block consists of 2 parts: a 2-hour education session called Empowered Relief® and 2 1-hour pain neuroscience education sessions. * Psychotherapy: The psychotherapy part consists of 1 group session of 1 hour, face-to-face and with groups of up to 15 people. * Therapeutic exercise: The therapeutic exercise module consists of 3 sessions of 1 hour each, face-to-face, with small groups of between 6 and 10 patients,
• Препарат Usual Care
  The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.

Первичные конечные точки

• Pain Intensity. Changes from baseline to 6 months. [Срок оценки: Baseline, 3 months, 6 months]
• Health-related quality of life. Changes from baseline to 6 months. [Срок оценки: Baseline, 3 months, 6 months]

Вторичные конечные точки (5)

• Pain-related Disability. Changes from baseline to 6 months. [Срок оценки: Baseline, 3 months, 6 months]
• Pain Catastrophizing. Changes from baseline to 6 months. [Срок оценки: Baseline, 3 months, 6 months]
• Perceived Social Support. Changes from baseline to 6 months. [Срок оценки: Baseline, 3 months, 6 months]
• Self-efficacy. Changes from baseline to 6 months. [Срок оценки: Baseline, 3 months, 6 months]
• Consumption of analgesic, anti-inflammatory and coadjuvant analgesic drugs [Срок оценки: Baseline, 3 months, 6 months]

Критерии участия

Критерии включения

• Patients over 18 years of age.
• Patients with primary chronic low back pain (non-specific chronic low back pain) of axial predominance.
• Experiencing pain at least 50% of the time over the last 6 months.
• Average weekly pain intensity equal or greater than 4 out of 10 on a verbal numerical scale.
• Be agreeable to receiving active, non-pharmacological and non-surgical treatment.

Критерии исключения

• Inflammatory low back pain.
• History of cancer in the last 5 years.
• Unexplained and unintentional weight loss of 10 Kg or more over the preceding 12-month period.
• Lack of control of bowel and bladder function (cauda equina).
• Difficulty in performing the sessions due to severe physical disability.
• Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder, etc.).
• Strong prescription opioid or parenteral medication addiction disorders.
• Technical-logistical problems (inability to attend treatment sessions or inability to fill out assessment questionnaires).
• Problems in understanding the content of the sessions (language barrier, severe hearing loss or severe cognitive impairment).
• Have sought compensation or entered into litigation in the preceding 12-month period.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Hospital Clínic de Barcelona — Barcelona
• Hospital Clínic de Barcelona — Barcelona

Публикации

• Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-23 PMID 28192789
• Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11. PMID 29138049
• Vlaeyen JWS, Maher CG, Wiech K, Van Zundert J, Meloto CB, Diatchenko L, Battie MC, Goossens M, Koes B, Linton SJ. Low back pain. Nat Rev Dis Primers. 2018 Dec 13;4(1):52. doi: 10.1038/s41572-018-0052-1. PMID 30546064
• Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Op PMID 34398206
• Ochandorena-Acha M, Dalmau-Roig A, Dursteler C, Vilchez-Oya F, Ferrer A, Martin-Villalba I, Obach A, Terradas-Monllor M. Acceptability of multimodal and multidisciplinary group-based program for chronic low back pain: a qualitative study. Physiother Theory Pract. 2025 May;41(5):981-997. doi: 10.1080/09593985.2024.2377343. Epub 2024 Jul 12. PMID 38994708
• Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021 May 29;397(10289):2082-2097. doi: 10.1016/S0140-6736(21)00393-7. PMID 34062143

Идентификаторы

NCT: NCT06679205 · HCB/2024/0791

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗