A Feasibility Study of a Multidisciplinary Treatment for Patients with Chronic Low Back Pain: PAINDOC Study.

NCT ID: NCT05974072

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-24
• Study Completion Date: 2023-11-01

Brief Summary

The present feasibility study aims to evaluate the feasibility and adequacy of a multidisciplinary treatment program as a therapeutic option for patients with chronic low back pain referred to the pain unit of the Hospital Clinic of Barcelona. Secondarily, the present study will also evaluate the effect on pain-related outcomes to estimate the number of needed participants for a full trial.

The main questions it aims to answer are:

• Is the proposed multidisciplinary treatment feasible and adequate for chronic low back pain patients?
• Is the proposed multidisciplinary treatment effective in improving pain-related outcomes?

Participants will receive either usual care (pharmacological control) or eight multidisciplinary sessions within two months, composed of therapeutic patient education, mindfulness relaxation, cognitive-behavioural therapy and therapeutic exercise. Besides, participants will be assessed using written questionnaires before and after treatment and two months after treatment.

Researchers will assess the feasibility of the multidisciplinary treatment group and will compare both groups to see if there is any difference in several pain-related outcomes.

Detailed Description

Despite improving pharmacological and surgical medical treatment options, long-lasting 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.

The present study aims to evaluate the viability and adequacy of a multidisciplinary treatment program (PAINDOC Program) as a therapeutic option for patients with chronic low back pain referred to the pain unit of the Hospital Clínic of Barcelona. The secondary objectives are to evaluate the effect of the PAINDOC Program on the reduction of pain intensity, the improvement of pain-related disability, the improvement of quality of life, and the reduction of pain catastrophizing.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care (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).

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: DRUG

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 8 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over two months.

It consists of a therapeutic education (Empowered Relief) session given by a physician from the unit, a pain psychology session given by a psychologist, an introductory mindfulness meditation session given by an advanced practice nurse, and two pain neuroscience education sessions and three 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.

Group Type: EXPERIMENTAL

PAINDOC Program

Intervention Type: OTHER

The PAINDOC Program consists in:

• Therapeutic education: The therapeutic education block consists of two parts: an education session called Empowered Relief (ER) and two pain neuroscience education (NDT) sessions.
• Psychotherapy: The psychotherapy part consists of one group session of one hour, face-to-face and with groups of up to 15 people, given by the psychologist of the pain unit.
• Mindfulness Meditation: The Mindfulness Meditation consists of one group session of one hour, face-to-face and with groups of up to 15 people. These are given by a nurse from the pain unit. T
• Therapeutic exercise: The therapeutic exercise module consists of three sessions of one hour each, face-to-face, with small groups of between 6 and 10 patients, and given by the physiotherapist of the pain unit.

Interventions

Usual Care

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

Intervention Type: DRUG

PAINDOC Program

The PAINDOC Program consists in:

• Therapeutic education: The therapeutic education block consists of two parts: an education session called Empowered Relief (ER) and two pain neuroscience education (NDT) sessions.
• Psychotherapy: The psychotherapy part consists of one group session of one hour, face-to-face and with groups of up to 15 people, given by the psychologist of the pain unit.
• Mindfulness Meditation: The Mindfulness Meditation consists of one group session of one hour, face-to-face and with groups of up to 15 people. These are given by a nurse from the pain unit. T
• Therapeutic exercise: The therapeutic exercise module consists of three sessions of one hour each, face-to-face, with small groups of between 6 and 10 patients, and given by the physiotherapist of the pain unit.

Intervention Type: OTHER

Other Intervention Names

Pharmacological Control; Multidisciplinary and multimodal intervention

Eligibility Criteria

Inclusion Criteria

• Patients with primary chronic low back pain (non-specific chronic low back pain).
• Predominantly axial pain, for at least 50% of the time during the last 6 months.
• Average pain intensity equal or greater than 4 out of 10 on a verbal numerical scale, during the present week.
• Predisposed to receive an active, non-pharmacological and non-surgical treatment.

Exclusion Criteria

• Inflammatory low back pain.
• History of cancer in the past 5 years.
• Unexplained and involuntary weight loss of 10 Kg during the last year.
• Problems in the control of bowel and bladder function.
• Difficulty attending sessions due to severe physical disability.
• Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder, etc.).
• Addiction disorder to parenteral drugs or strong prescription opioids. Technical-logistical problems (inability to attend treatment sessions, inability to complete evaluation questionnaires).
• Seeking compensation or litigation in the last year.
• Severe hearing loss or severe cognitive impairment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Marc Terradas Monllor

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

Countries

Spain

References

Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.

Reference Type: BACKGROUND

PMID: 27002445 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34062143 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34398206 (View on PubMed)

Dalmau-Roig A, Dursteler C, Ochandorena-Acha M, Vilchez-Oya F, Martin-Villalba I, Obach A, Terradas-Monllor M. A multidisciplinary pain management program for patients with chronic low back pain: a randomized, single-blind, controlled, feasibility study. BMC Musculoskelet Disord. 2025 Jan 17;26(1):59. doi: 10.1186/s12891-025-08294-8.

Reference Type: DERIVED

PMID: 39825315 (View on PubMed)

Other Identifiers

PAINDOC

Identifier Type: -

Identifier Source: org_study_id