Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-01-08 @ 4:05 AM
Study NCT ID:
NCT06679205
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity. Changes from baseline to 6 months.', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '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.'}, {'measure': 'Health-related quality of life. Changes from baseline to 6 months.', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Pain-related Disability. Changes from baseline to 6 months.', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '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).'}, {'measure': 'Pain Catastrophizing. Changes from baseline to 6 months.', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '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.'}, {'measure': 'Perceived Social Support. Changes from baseline to 6 months.', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '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.'}, {'measure': 'Self-efficacy. Changes from baseline to 6 months.', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '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.'}, {'measure': 'Consumption of analgesic, anti-inflammatory and coadjuvant analgesic drugs', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic low-back pain', 'chronic pain', 'pain catastrophizing', 'multidisciplinary treatment', 'therapeutic exercice', 'pain neuroscience education', 'cognitive behavioural therapy', 'therapeutic education'], 'conditions': ['Chronic Low-back Pain (cLBP)', 'Chronic Low-back Pain', 'Back Pain']}, 'referencesModule': {'references': [{'pmid': '28192789', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29138049', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30546064', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34398206', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38994708', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34062143', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nAs secondary objectives, the present study aims to evaluate the effect of the PAINDOC program on:\n\n* The reduction of pain-related disability.\n* The reduction of pain catastrophizing.\n* The improvement in perceived social support.\n* The improvement in perceived autonomy (self-efficacy).\n* The reduction of analgesic, anti-inflammatory and adjuvant analgesic medication.\n\nThe main questions it aims to answer are:\n\n* Is the proposed multidisciplinary treatment effective in improving pain-related outcomes?\n* Is the proposed multidisciplinary treatment effective in reducing analgesic medication?\n\nParticipants 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.\n\nResearchers will assess the effectiveness of the multidisciplinary treatment group comparing both groups to see if there is any difference in several pain-related outcomes.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Patients with primary chronic low back pain (non-specific chronic low back pain) of axial predominance.\n* Experiencing pain at least 50% of the time over the last 6 months.\n* Average weekly pain intensity equal or greater than 4 out of 10 on a verbal numerical scale.\n* Be agreeable to receiving active, non-pharmacological and non-surgical treatment.\n\nExclusion Criteria:\n\n* Inflammatory low back pain.\n* History of cancer in the last 5 years.\n* Unexplained and unintentional weight loss of 10 Kg or more over the preceding 12-month period.\n* Lack of control of bowel and bladder function (cauda equina).\n* Difficulty in performing the sessions due to severe physical disability.\n* Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder, etc.).\n* Strong prescription opioid or parenteral medication addiction disorders.\n* Technical-logistical problems (inability to attend treatment sessions or inability to fill out assessment questionnaires).\n* Problems in understanding the content of the sessions (language barrier, severe hearing loss or severe cognitive impairment).\n* Have sought compensation or entered into litigation in the preceding 12-month period.'}, 'identificationModule': {'nctId': 'NCT06679205', 'acronym': 'PAINDOC', 'briefTitle': 'Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Barcelona'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'HCB/2024/0791'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacological control', 'description': '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).', 'interventionNames': ['Drug: Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'PAINDOC program', 'description': "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.", 'interventionNames': ['Behavioral: Multidisciplinary and multimodal intervention']}], 'interventions': [{'name': 'Multidisciplinary and multimodal intervention', 'type': 'BEHAVIORAL', 'otherNames': ['PAINDOC program'], 'description': 'The PAINDOC Program consists in:\n\n* 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.\n* Psychotherapy: The psychotherapy part consists of 1 group session of 1 hour, face-to-face and with groups of up to 15 people.\n* 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.', 'armGroupLabels': ['PAINDOC program']}, {'name': 'Usual Care', 'type': 'DRUG', 'otherNames': ['Pharmacological Control'], 'description': 'The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.', 'armGroupLabels': ['Pharmacological control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08006', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Anna Dalmau-Roig, MD', 'role': 'CONTACT', 'email': 'dalmaur@clinic.cat', 'phone': '+34 639482849'}, {'name': 'Marc Terradas-Monllor, PhD', 'role': 'CONTACT', 'email': 'marc.terradas@uvic.cat', 'phone': '+34 652948632'}, {'name': 'Anna Dalmau-Roig, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Spain', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Anna Dalmau-Roig', 'role': 'CONTACT', 'email': 'dalmaur@clinic.cat', 'phone': '+34639482849'}], 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Anna Dalmau-Roig, MD', 'role': 'CONTACT', 'email': 'dalmaur@clinic.cat', 'phone': '+34 639482849'}, {'name': 'Marc Terradas-Monllor, PhD', 'role': 'CONTACT', 'email': 'marc.terradas@uvic.cat', 'phone': '+34 652948632'}], 'overallOfficials': [{'name': 'Marc Terradas-Monllor, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Vic'}, {'name': 'Christian Dürsteler, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Barcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Dalmau Roig', 'investigatorAffiliation': 'University of Barcelona'}}}}