Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain
NCT ID: NCT06679205
Last Updated: 2025-03-30
Study Results
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Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2025-01-14
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pharmacological control
The subjects in the control group will be treated following a pharmacological approach according to the latest clinical guidelines for patients with chronic low back pain. Thus, the pharmacological options to be considered in each patient will be those included in the first and second analgesic steps of the WHO (preferably without including minor opioids).
Usual Care
The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.
PAINDOC program
The PAINDOC Program is a multidisciplinary treatment that integrates four parts provided by different health professionals and consists of 7 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over 2 months. It consists of a therapeutic education session (Empowered Relief®) given by a physician from the unit, a pain psychology session given by a psychologist, and 2 pain neuroscience education sessions and 3 therapeutic exercise sessions given by a physiotherapist. This program is already part of the pain unit's routine care practice, so it is considered that the sessions of this program do not represent an additional and specific visit for the patients.
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, and given by the physiotherapist of the pain unit.
Interventions
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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, and given by the physiotherapist of the pain unit.
Usual Care
The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
University of Barcelona
OTHER
Responsible Party
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Anna Dalmau Roig
Principal Investigator
Principal Investigators
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Marc Terradas-Monllor, PhD
Role: STUDY_DIRECTOR
University of Vic
Christian Dürsteler, PhD
Role: STUDY_DIRECTOR
University of Barcelona
Locations
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Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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/M16-2367. Epub 2017 Feb 14.
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.
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.
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 Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401.
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.
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.
Other Identifiers
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HCB/2024/0791
Identifier Type: -
Identifier Source: org_study_id
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