CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Usual Care +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05974072
NCT05974072N/ACompleted

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

University of Barcelona·interventional·Posted Aug 3, 2023·Updated Oct 8, 2024

In Brief

A clinical study evaluating Usual Care and PAINDOC Program for Chronic Low-back Pain. Completed, enrolled 41 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 3, 2023
Enrollment StartJan 24, 2023
Primary CompletionNov 1, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.9 years ago

Interventions

Usual Caredrug

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

PAINDOC Programother

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.