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

CompletedNot applicableNCT05974072
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Official title
A Feasibility Study of a Multidisciplinary Treatment for Patients with Chronic Low Back Pain: PAINDOC Study.
Interventions
  • Drug: Usual Care
  • Other: PAINDOC Program
Sponsor
University of Barcelona
Start date
2023-01-24
Primary completion
2023-11-01
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Spain
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05974072