Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Barcelona
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Inflammatory low back pain.
History of cancer in the last 5 years.
Unexplained and unintentional weight loss of 10 Kg or more over the preceding 12-month period.
Lack of control of bowel and bladder function (cauda equina).
Trial design
Design model
Parallel
Treatments tested in this trial
Multidisciplinary and multimodal intervention
BehavioralThe PAINDOC Program consists in: * Therapeutic education: The therapeutic education block consists of 2 parts: a 2-hour education session called Empowered Relief® and 2 1-hour pain neuroscience education sessions. * Psychotherapy: The psychotherapy part consists of 1 group session of 1 hour, face-to-face and with groups of up to 15 people. * Therapeutic exercise: The therapeutic exercise module consists of 3 sessions of 1 hour each, face-to-face, with small groups of between 6 and 10 patients, and given by the physiotherapist of the pain unit.
Usual Care
DrugThe pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Pharmacological controlActive comparator 1 intervention
Group B: PAINDOC programExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity. Changes from baseline to 6 months.
Participants will be asked to rate their pain intensity on a horizontal 100-mm Visual Analogue Scale (VAS), ranging from 0 = no pain to 100 = worst imaginable pain. The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in low back pain patients. For patients with subacute or chronic low back pain, the minimum clinically relevant change is considered to be at least 20 mm on a VAS.
Time frame
Baseline, 3 months, 6 months2
Health-related quality of life. Changes from baseline to 6 months.
The spanish version of the Euro Quality of Life 5D-5L (EQ-5D-5L) was used to assess the health related quality of life (HRQL).(10) The EQ-5D-5L consists in two pages: the first one is based on a descriptive system that defines health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories: no problems, slight problems, moderate problems, severe problems, extreme problems.(10) A health state is composed by taking one level for each dimension, and a preference-based scoring function is used to convert the descriptive system to a summary index score (ranging from states worse than dead \<0 to full health 1).
Time frame
Baseline, 3 months, 6 monthsSecondary outcomes
1
Pain-related Disability. Changes from baseline to 6 months.
Disability will be assessed using the spanish version of the Oswestry Disability Index (ODI) questionnaire. The ODI is one of the most common specific measurement tools to evaluate the function and disability of lumbar spine pathologies. This questionnaire contains 10 items evaluated from 0 to 5 (higher values indicate greater disability), which correspond to 10 domains. The sum of the 10 scores is expressed as a percentage (ODI score), with ranges from 0% (no disability) to 100% (maximum disability).
Time frame
Baseline, 3 months, 6 months2
Pain Catastrophizing. Changes from baseline to 6 months.
The Spanish version of Pain Catastrophizing Scale (PCS) was used to asses thoughts and feelings related to pain experiences.(9) The PCS is a 13 item self-administered questionnaire composed of 3 subscales: rumination, magnification and helplessness. The PCS uses a 5-point Likert scale with responses ranging from 0 = not at all to 4 = all the time. Overall scores range from 0 to 52 points, the higher the score, the higher is the pain catastrophism level.
Time frame
Baseline, 3 months, 6 months3
Perceived Social Support. Changes from baseline to 6 months.
It will be assessed using the Lubben Social Network Scale (LSNS-6), which was developed to assess the perceived social support of an adult person according to the size of his or her social network, the trust that these ties generate and the frequency of contacts that this person has with those around him or her. The LSNS-6 includes 6 questions divided into 2 domains: 3 on family and 3 on friendships. It is one of the most widely used by the international community and its application is simple and brief, which is of vital importance for its feasibility in the clinical setting. The Spanish version of the LSNS-6 has proven to be valid and reliable.
Time frame
Baseline, 3 months, 6 months4
Self-efficacy. Changes from baseline to 6 months.
Self-efficacy will be assessed using the Spanish version of the Chronic Pain Self-Efficacy Scale (CPSES). The CPSES is a 19-item self-administered questionnaire. Each item assesses the ability that the person believes he or she has to perform a certain task or activity and is presented in the form of a question. The person must consider each question on a 10-point Likert scale, with a range of 0 to 10, where 0 is "I think I am totally incapable" and 10 is "I think I am totally capable." The total score can range from 0 to 190 points, indicating greater self-efficacy in chronic pain the higher the score. This questionnaire is divided into 3 dimensions: self-efficacy in symptom control, self-efficacy in physical functioning, and self-efficacy in pain management.
Time frame
Baseline, 3 months, 6 monthsSponsors and contacts
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University of Barcelona
Lead sponsor
Hospital Clinic of Barcelona
Collaborator
Source ClinicalTrials.gov