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Chronic Low-back Pain (cLBP)PAINDOCNCT06679205

Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain

A study testing Multidisciplinary and multimodal intervention in people with Chronic Low-back Pain (cLBP) and Chronic Low-back Pain, run by University of Barcelona at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Multidisciplinary and multimodal intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesSpain
Study dates
14 Jan 2025to Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
  • Difficulty in performing the sessions due to severe physical disability.
  • Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder, etc.).
Show all 10Show fewer
  • Strong prescription opioid or parenteral medication addiction disorders.
  • Technical-logistical problems (inability to attend treatment sessions or inability to fill out assessment questionnaires).
  • Problems in understanding the content of the sessions (language barrier, severe hearing loss or severe cognitive impairment).
  • Have sought compensation or entered into litigation in the preceding 12-month period.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Dalmau-Roig, MD contact

+34 639482849

dalmaur@clinic.cat

Marc Terradas-Monllor, PhD contact

+34 652948632

marc.terradas@uvic.cat

Spain2 sites, 2 recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08006

    Anna Dalmau-Roig, MD, +34 639482849, dalmaur@clinic.cat

    Marc Terradas-Monllor, PhD, +34 652948632, marc.terradas@uvic.cat

    Not yet recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Spain, 08036

    Anna Dalmau-Roig, +34639482849, dalmaur@clinic.cat

    Recruiting

Other trials in Spain

About this study

Official title: 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)

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.

Read more

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.

Read the detailed description

Despite improving pharmacological and surgical medical treatment options, chronic 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.

Being tested
Multidisciplinary and multimodal intervention, Usual Care
Keywords
chronic low-back pain, chronic pain, pain catastrophizing, multidisciplinary treatment, therapeutic exercice, pain neuroscience education, cognitive behavioural therapy, therapeutic education
Medical subject headings
Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary and multimodal interventionBehavioural

    Also called PAINDOC program

    The 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 CareDrug

    Also called Pharmacological Control

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

Study groups in NCT06679205
Study groupRoleWhat they receive
Pharmacological controlActive comparatorThe 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).
Receives: Drug: Usual Care
PAINDOC programExperimentalThe 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.
Receives: Behavioral: Multidisciplinary and multimodal intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 3 months, 6 months

  2. 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).

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (5)

  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).

    Measured: Baseline, 3 months, 6 months

  2. 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.

    Measured: Baseline, 3 months, 6 months

  3. 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.

    Measured: Baseline, 3 months, 6 months

  4. 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.

    Measured: Baseline, 3 months, 6 months

  5. Consumption of analgesic, anti-inflammatory and coadjuvant analgesic drugs

    The doses of analgesic, anti-inflammatory and coadjuvant analgesic drugs taken by each participant will be recorded, expressed in mg/day, except for opioids, where the Morphine Equivalent Dose (MED) will be used.

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2024
  2. Study start14 Jan 2025
  3. Primary completionJan 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06679205
Sponsor's protocol ID
HCB/2024/0791
Acronym
PAINDOC
Status last verified
Mar 2025
First submitted
5 Nov 2024
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.

    PubMed 28192789

  • Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.

    PubMed 29138049

  • Vlaeyen JWS, Maher CG, Wiech K, Van Zundert J, Meloto CB, Diatchenko L, Battie MC, Goossens M, Koes B, Linton SJ. Low back pain. Nat Rev Dis Primers. 2018 Dec 13;4(1):52. doi: 10.1038/s41572-018-0052-1.

    PubMed 30546064

  • Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401.

    PubMed 34398206

  • Ochandorena-Acha M, Dalmau-Roig A, Dursteler C, Vilchez-Oya F, Ferrer A, Martin-Villalba I, Obach A, Terradas-Monllor M. Acceptability of multimodal and multidisciplinary group-based program for chronic low back pain: a qualitative study. Physiother Theory Pract. 2025 May;41(5):981-997. doi: 10.1080/09593985.2024.2377343. Epub 2024 Jul 12.

    PubMed 38994708

  • Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021 May 29;397(10289):2082-2097. doi: 10.1016/S0140-6736(21)00393-7.

    PubMed 34062143

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary and multimodal intervention in people with Chronic Low-back Pain (cLBP) and Chronic Low-back Pain, run by University of Barcelona at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Dalmau-Roig, MD (+34 639482849, dalmaur@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity. Changes from baseline to 6 months. (time frame: Baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06679205, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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