Chronic Low-back PainNCT05974072
A Feasibility Study of a Multidisciplinary Treatment for Patients with Chronic Low Back Pain: PAINDOC Study.
A study testing PAINDOC Program in people with Chronic Low-back Pain, run by University of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- PAINDOC Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 24 Jan 2023to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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.
Who cannot join
- 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.).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the detailed description
Despite improving pharmacological and surgical medical treatment options, long-lasting 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.
The present study aims to evaluate the viability and adequacy of a multidisciplinary treatment program (PAINDOC Program) as a therapeutic option for patients with chronic low back pain referred to the pain unit of the Hospital Clínic of Barcelona. The secondary objectives are to evaluate the effect of the PAINDOC Program on the reduction of pain intensity, the improvement of pain-related disability, the improvement of quality of life, and the reduction of pain catastrophizing.
- Conditions
- Chronic Low-back Pain
- Being tested
- Usual Care, PAINDOC Program
- Keywords
- chronic pain, pain catastrophizing, therapeutic patient education, therapeutic exercise, mindfulness, cognitive behavioural therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareDrug
Also called Pharmacological Control
The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.
PAINDOC ProgramOther
Also called Multidisciplinary and multimodal intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Pharmacological Control) | Active comparator | 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). Receives: Drug: Usual Care |
| PAINDOC Program | Experimental | The PAINDOC Program is a multidisciplinary treatment that integrates four parts provided by different health professionals and consists of 8 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over two months.
It consists of a therapeutic education (Empowered Relief) session given by a physician from the unit, a pain psychology session given by a psychologist, an introductory mindfulness meditation session given by an advanced practice nurse, and two pain neuroscience education sessions and three 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: Other: PAINDOC Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
To obtain this information, the number of participants included in the program for four consecutive months will be calculated. The number of eligible participants, the number of participants included and excluded, and the reasons for exclusion will be detailed.
Measured: 4 months prior to study start
Number of participants completing treatment
Acceptable compliance has been defined as at least 80% of participants included in the program completing all program sessions.
Measured: 2 months
Follow-up rate
to determine the follow-up rate, the number of participants who complete the evaluations at each evaluation point in the study will be detailed.
Measured: 4 months
Acceptance of treatment and detection of barriers
Treatment acceptance will be assessed through a qualitative approach, based on focus groups and content analysis. The study will have a phenomenological approach to understand and know directly the experiences of the participants. The research will be conducted from the interpretive paradigm, as it seeks to understand and interpret the deep meaning of the observed phenomena. In addition, it is based on an inductive methodology that starts from reality to generate theories, so the fieldwork does not start from a hypothesis.
Measured: 2 months
Secondary outcomes (4)
Pain Intensity. Changes from baseline to 2 months after treatment.
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, 2 months, 4 months
Pain-related disability. Changes from baseline to 2 months after treatment.
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, 2 months, 4 months
Health-related quality of life. Changes from baseline to 2 months after treatment.
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, 2 months, 4 months
Pain Catastrophizing. Changes from baseline to 2 months after treatment.
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, 2 months, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start24 Jan 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Terradas Monllor, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974072
- Sponsor's protocol ID
- PAINDOC
- Status last verified
- Oct 2024
- First submitted
- 11 Jul 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
PubMed 27002445Cohen 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 34062143Darnall 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 34398206Dalmau-Roig A, Dursteler C, Ochandorena-Acha M, Vilchez-Oya F, Martin-Villalba I, Obach A, Terradas-Monllor M. A multidisciplinary pain management program for patients with chronic low back pain: a randomized, single-blind, controlled, feasibility study. BMC Musculoskelet Disord. 2025 Jan 17;26(1):59. doi: 10.1186/s12891-025-08294-8.
PubMed 39825315
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Multidisciplinary Treatment for Patients with Chronic Low Back Pain: PAINDOC Study.
- ClinicalTrials.gov ID
- NCT05974072
- Acronym / sponsor ID
- PAINDOC
- Conditions
- Chronic Low-back Pain
- Keywords
- chronic pain, pain catastrophizing, therapeutic patient education, therapeutic exercise, mindfulness, cognitive behavioural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite improving pharmacological and surgical medical treatment options, long-lasting 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.
The present study aims to evaluate the viability and adequacy of a multidisciplinary treatment program (PAINDOC Program) as a therapeutic option for patients with chronic low back pain referred to the pain unit of the Hospital Clínic of Barcelona. The secondary objectives are to evaluate the effect of the PAINDOC Program on the reduction of pain intensity, the improvement of pain-related disability, the improvement of quality of life, and the reduction of pain catastrophizing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Pharmacological Control) | Active comparator | Drug: Usual CareThe 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). |
| PAINDOC Program | Experimental | Other: PAINDOC ProgramThe PAINDOC Program is a multidisciplinary treatment that integrates four parts provided by different health professionals and consists of 8 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over two months. It consists of a therapeutic education (Empowered Relief) session given by a physician from the unit, a pain psychology session given by a psychologist, an introductory mindfulness meditation session given by an advanced practice nurse, and two pain neuroscience education sessions and three 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareAlso: Pharmacological ControlThe pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects. | Drug | Usual Care (Pharmacological Control) |
| PAINDOC ProgramAlso: Multidisciplinary and multimodal interventionThe 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. | Other | PAINDOC Program |
Primary outcome
Recruitment rate
Time frame: 4 months prior to study start
To obtain this information, the number of participants included in the program for four consecutive months will be calculated. The number of eligible participants, the number of participants included and excluded, and the reasons for exclusion will be detailed.
Number of participants completing treatment
Time frame: 2 months
Acceptable compliance has been defined as at least 80% of participants included in the program completing all program sessions.
Follow-up rate
Time frame: 4 months
to determine the follow-up rate, the number of participants who complete the evaluations at each evaluation point in the study will be detailed.
Acceptance of treatment and detection of barriers
Time frame: 2 months
Treatment acceptance will be assessed through a qualitative approach, based on focus groups and content analysis. The study will have a phenomenological approach to understand and know directly the experiences of the participants. The research will be conducted from the interpretive paradigm, as it seeks to understand and interpret the deep meaning of the observed phenomena. In addition, it is based on an inductive methodology that starts from reality to generate theories, so the fieldwork does not start from a hypothesis.
4 secondary outcomes
Pain Intensity. Changes from baseline to 2 months after treatment.
Time frame: Baseline, 2 months, 4 months
Pain-related disability. Changes from baseline to 2 months after treatment.
Time frame: Baseline, 2 months, 4 months
Health-related quality of life. Changes from baseline to 2 months after treatment.
Time frame: Baseline, 2 months, 4 months
Pain Catastrophizing. Changes from baseline to 2 months after treatment.
Time frame: Baseline, 2 months, 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 27002445Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
- Background: PubMed 34062143Cohen 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.
- Background: PubMed 34398206Darnall 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.
- Derived from this study: PubMed 39825315Dalmau-Roig A, Dursteler C, Ochandorena-Acha M, Vilchez-Oya F, Martin-Villalba I, Obach A, Terradas-Monllor M. A multidisciplinary pain management program for patients with chronic low back pain: a randomized, single-blind, controlled, feasibility study. BMC Musculoskelet Disord. 2025 Jan 17;26(1):59. doi: 10.1186/s12891-025-08294-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAINDOC Program in people with Chronic Low-back Pain, run by University of Barcelona at 1 site 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 4 months prior to study start). The study lists 4 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 NCT05974072, which also lists 4 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 8 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.