A Feasibility Study of a Multidisciplinary Treatment for Patients With

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05974072
Study type	Interventional
Source	University of Barcelona
Contact	Marc Terradas-Monllor, PhD
Phone	+34 652948632
Email	marc.terradas@uvic.cat
Status	Recruiting
Phase	N/A
Start date	January 24, 2023
Completion date	December 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms