Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain (PAINDOC Protocol): Randomized, Parallel-group, Two-arm, Single-blind Clinical Trial (PAINDOC Project)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

PAINDOC is a treatment program that includes 4 disciplines that, separately, have demonstrated their effectiveness in the treatment of chronic low back pain: education in pain neuroscience, therapeutic education (Empowered Relief®), psychotherapy based on cognitive-behavioral therapy and therapeutic exercise. The primary objective of the study is to evaluate the effectiveness of the PAINDOC multidisciplinary treatment program in reducing pain intensity and improving quality of life in persons with chronic low back pain referred to the pain unit of the Hospital Clinic of Barcelona, compared to usual care treatment. As secondary objectives, the present study aims to evaluate the effect of the PAINDOC program on: * The reduction of pain-related disability. * The reduction of pain catastrophizing. * The improvement in perceived social support. * The improvement in perceived autonomy (self-efficacy). * The reduction of analgesic, anti-inflammatory and adjuvant analgesic medication. The main questions it aims to answer are: * Is the proposed multidisciplinary treatment effective in improving pain-related outcomes? * Is the proposed multidisciplinary treatment effective in reducing analgesic medication? Participants will receive either usual care (pharmacological control) or the PAINDOC program, which consists of 7 multidisciplinary sessions within 2 months. There will be one therapeutic education session called Empowered Relief®, 2 pain neuroscience education sessions, one pain psychology session and 3 therapeutic education sessions. Besides, participants will be assessed using written questionnaires before treatment, at 3 months and at 6 months. Researchers will assess the effectiveness of the multidisciplinary treatment group comparing both groups to see if there is any difference in several pain-related outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients over 18 years of age.

• Patients with primary chronic low back pain (non-specific chronic low back pain) of axial predominance.

• Experiencing pain at least 50% of the time over the last 6 months.

• Average weekly pain intensity equal or greater than 4 out of 10 on a verbal numerical scale.

• Be agreeable to receiving active, non-pharmacological and non-surgical treatment.

Locations
Other Locations
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Clínic de Barcelona
NOT_YET_RECRUITING
Barcelona
Contact Information
Primary
Anna Dalmau-Roig, MD
dalmaur@clinic.cat
+34 639482849
Backup
Marc Terradas-Monllor, PhD
marc.terradas@uvic.cat
+34 652948632
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2026-03
Participants
Target number of participants: 62
Treatments
Active_comparator: 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).
Experimental: PAINDOC program
The PAINDOC Program is a multidisciplinary treatment that integrates four parts provided by different health professionals and consists of 7 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over 2 months. It consists of a therapeutic education session (Empowered Relief®) given by a physician from the unit, a pain psychology session given by a psychologist, and 2 pain neuroscience education sessions and 3 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.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Clinic of Barcelona
Leads: University of Barcelona

This content was sourced from clinicaltrials.gov