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

NCT05974072 | Completed

• 1 other identifier: PAINDOC
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

chronic pain; pain catastrophizing; therapeutic patient education; therapeutic exercise; mindfulness; cognitive behavioural therapy

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  To obtain this information, the number of participants included in the program for four consecutive months will be calculated. The number of eligible participants, the number of participants included and excluded, and the reasons for exclusion will be detailed.

  4 months prior to study start

• Number of participants completing treatment

  Acceptable compliance has been defined as at least 80% of participants included in the program completing all program sessions.

  2 months

• Follow-up rate

  to determine the follow-up rate, the number of participants who complete the evaluations at each evaluation point in the study will be detailed.

  4 months

• Acceptance of treatment and detection of barriers

  Treatment acceptance will be assessed through a qualitative approach, based on focus groups and content analysis. The study will have a phenomenological approach to understand and know directly the experiences of the participants. The research will be conducted from the interpretive paradigm, as it seeks to understand and interpret the deep meaning of the observed phenomena. In addition, it is based on an inductive methodology that starts from reality to generate theories, so the fieldwork does not start from a hypothesis.

  2 months

Secondary Outcomes (4)

• Pain Intensity. Changes from baseline to 2 months after treatment.

  Baseline, 2 months, 4 months

• Pain-related disability. Changes from baseline to 2 months after treatment.

  Baseline, 2 months, 4 months

• Health-related quality of life. Changes from baseline to 2 months after treatment.

  Baseline, 2 months, 4 months

• Pain Catastrophizing. Changes from baseline to 2 months after treatment.

  Baseline, 2 months, 4 months

Study Arms (2)

Usual Care (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 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.

Other: PAINDOC Program

Interventions

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

Usual Care (Pharmacological Control)

PAINDOC Program 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.

Also known as: Multidisciplinary and multimodal intervention

PAINDOC Program

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08006, Spain

Location

Related Publications (4)

• 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.

  PMID: 27002445 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

• 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

• 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.

  PMID: 39825315 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two armed, parallel groups, single blind, unicentric, randomized feasibility study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 3, 2023
• Study Start: January 24, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)