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

NCT06679205 | Recruiting

• 1 other identifier: HCB/2024/0791
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Low-back Pain (cLBP); Chronic Low-back Pain; Back Pain

Keywords

chronic low-back pain; chronic pain; pain catastrophizing; multidisciplinary treatment; therapeutic exercice; pain neuroscience education; cognitive behavioural therapy; therapeutic education

Outcome Measures

Primary Outcomes (2)

• Pain Intensity. Changes from baseline to 6 months.

  Participants will be asked to rate their pain intensity on a horizontal 100-mm Visual Analogue Scale (VAS), ranging from 0 = no pain to 100 = worst imaginable pain. The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in low back pain patients. For patients with subacute or chronic low back pain, the minimum clinically relevant change is considered to be at least 20 mm on a VAS.

  Baseline, 3 months, 6 months

• Health-related quality of life. Changes from baseline to 6 months.

  The spanish version of the Euro Quality of Life 5D-5L (EQ-5D-5L) was used to assess the health related quality of life (HRQL).(10) The EQ-5D-5L consists in two pages: the first one is based on a descriptive system that defines health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories: no problems, slight problems, moderate problems, severe problems, extreme problems.(10) A health state is composed by taking one level for each dimension, and a preference-based scoring function is used to convert the descriptive system to a summary index score (ranging from states worse than dead \<0 to full health 1).

  Baseline, 3 months, 6 months

Secondary Outcomes (5)

• Pain-related Disability. Changes from baseline to 6 months.

  Baseline, 3 months, 6 months

• Pain Catastrophizing. Changes from baseline to 6 months.

  Baseline, 3 months, 6 months

• Perceived Social Support. Changes from baseline to 6 months.

  Baseline, 3 months, 6 months

• Self-efficacy. Changes from baseline to 6 months.

  Baseline, 3 months, 6 months

• Consumption of analgesic, anti-inflammatory and coadjuvant analgesic drugs

  Baseline, 3 months, 6 months

Study Arms (2)

Pharmacological control

ACTIVE COMPARATOR

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).

Drug: Usual Care

PAINDOC program

EXPERIMENTAL

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.

Behavioral: Multidisciplinary and multimodal intervention

Interventions

Multidisciplinary and multimodal intervention BEHAVIORAL

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.

Also known as: PAINDOC program

PAINDOC program

Usual Care DRUG

The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.

Also known as: Pharmacological Control

Pharmacological control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (2)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08006, Spain

NOT YET RECRUITING

Hospital Clínic de Barcelona

Barcelona, Spain, 08036, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 28192789 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e229739. doi: 10.1001/jamanetworkopen.2022.9739.

  PMID: 34398206 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Terradas-Monllor, PhD

  University of Vic

  STUDY DIRECTOR

• Christian Dürsteler, PhD

  University of Barcelona

  STUDY DIRECTOR

Central Study Contacts

Anna Dalmau-Roig, MD

CONTACT

+34 639482849; dalmaur@clinic.cat

Marc Terradas-Monllor, PhD

CONTACT

+34 652948632; marc.terradas@uvic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: January 14, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)