Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 1:34 AM
Study NCT ID:
NCT07118033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Algo K Specific Manual Therapy for Sub Acute Low Back Pain With Radicular Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'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': ['PARTICIPANT'], 'maskingDescription': 'Patients unaware of allocation ; sham mobilization in control arm'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups, both of them will execute the same standard physiotherapy care based on exercise and education for 25 minutes for each session, randomly assigned 1:1.\n\nFor the control group, they will have a 5 minutes postero-anterior mobilisation procedure on a upper thoracic vertebra For the interventional group, they will have a 5 minutes postero-anterior mobilisation procedure on a lumbar vertebra, determined by the algorithm'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI, %)', 'timeFrame': 'Baseline day to 26-30', 'description': 'Patient-reported disability (ODI French version)'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI, %)', 'timeFrame': 'day 52-60 /or visit 12', 'description': 'Disability at end of follow-up'}, {'measure': 'Pain intensity (numeric rating scale, 0-10)', 'timeFrame': 'Baseline day 26-30 ; day 52-60 /or visit 12', 'description': 'Average pain last 24h'}, {'measure': 'Pain topography (body diagram score)', 'timeFrame': 'Baseline day 26-30 ; day 52-60 /or visit 12', 'description': 'Distal extension of symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Manual therapy', 'Physiotherapy', 'Decision making'], 'conditions': ['Sub Acute Low Back Pain With Radiating Symptoms']}, 'descriptionModule': {'briefSummary': "This study evaluates the effectiveness of a specific manual therapy approach based on the Algo-K decision algorithm in patients with subacute low back pain radiating to the lower limb. Algo-K helps select the most suitable lumbar mobilization technique according to the patient's pain response. The experimental group will receive a five-minute targeted manual therapy in addition to standard physiotherapy, while the control group will receive a non-specific mobilization. The study aims to determine whether this algorithm-guided intervention leads to faster and greater improvement in pain and disability.", 'detailedDescription': "Subacute low back pain (LBP) with radiating symptoms is a common musculoskeletal disorder with a risk of chronicization. Manual therapy is often used in physiotherapy to treat LBP, but its effectiveness varies widely due to heterogeneous practices and lack of specificity. The Algo-K algorithm was developed to guide therapists in selecting the most appropriate mobilization technique based on patients' symptomatic responses during movement tests.\n\nThis multicenter randomized controlled trial compares the effectiveness of a specific manual therapy guided by the Algo-K algorithm versus a non-specific manual therapy added to a standardized exercise-based physiotherapy program. Sixty adult patients with subacute LBP and radiating pain will be included. Participants will be randomly assigned to either:\n\n* Experimental group: 5 minutes of specific lumbar mobilizations based on the Algo-K decision tree;\n* Control group: 5 minutes of non-specific mobilization at a distant thoracic level.\n\nBoth groups will receive the same standard physiotherapy care based on exercise and education, delivered over 12 sessions within a 60-day period.\n\nThe primary outcome is the Oswestry Disability Index (ODI) score at 26-30 days. Secondary outcomes include pain intensity (Numeric Rating Scale), pain distribution (body diagram), and long-term disability (ODI at 52-60 days). The hypothesis is that the specific, patient-tailored manual therapy will improve functional outcomes and reduce pain more effectively than non-specific mobilization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 65 y o\n* Sub acute low back pain (7 days - 3 months) with irradiation to one lower limb, pain 3 10/10\n* Mechanically responsive pain\n* ODI \\> 20 % and \\< 80 %\n* Prescription ≥ 12 physiotherapy sessions (or un specified)\n* Able to complete 12 sessions in ≤ 60 days\n* Affiliated to French social security\n* Signed informed consent\n\nExclusion Criteria:\n\n* Suspicion or history of serious pathology (cancer, systemic inflammatory disease, etc.)\n* Main complaint other than low back pain with irradiation\n* Prior spine or hip surgery (no time limit) / thoraco abdominal surgery \\< 3 y\n* Central Sensitization Inventory ≥ 37\n* HAD anxiety or depression sub score ≥ 8\n* Planned lumbar infiltration during follow up\n* Pregnancy or breastfeeding\n* Legal protection (guardianship, custody, imprisonment)'}, 'identificationModule': {'nctId': 'NCT07118033', 'acronym': 'ALGO-K', 'briefTitle': 'Algo K Specific Manual Therapy for Sub Acute Low Back Pain With Radicular Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of the Specificity of a Manual Therapy Based on a Decision Algorithm (Algo-K) in the Physiotherapy Treatment of Sub Acute Low Back Pain With Radiating Pain', 'orgStudyIdInfo': {'id': 'APHP230858'}, 'secondaryIdInfos': [{'id': '2024-A01892-45', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Specific manual therapy', 'description': 'Usual exercise based physiotherapy + 5 min lumbar PA mobilisations chosen with Algo K algorithm based on symptom response', 'interventionNames': ['Procedure: Specific Manual Therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Non specific manual therapy', 'description': 'Same physiotherapy + 5 min PA mobilisations in upper thoracic spine, distant from symptoms', 'interventionNames': ['Procedure: Non specific Manual Therapy']}], 'interventions': [{'name': 'Specific Manual Therapy', 'type': 'PROCEDURE', 'description': "Participants in this group receive a standardized physiotherapy program (exercise and education) plus 5 minutes of targeted lumbar postero anterior mobilizations. These mobilizations are selected using the Algo K decision algorithm, which guides the therapist to choose the most appropriate technique based on the patient's pain response during preliminary movement tests.", 'armGroupLabels': ['Specific manual therapy']}, {'name': 'Non specific Manual Therapy', 'type': 'PROCEDURE', 'description': "Participants in this group receive the same physiotherapy program, but the additional 5 minutes of mobilization are applied to the upper thoracic spine (T4-T7), away from the symptomatic lumbar region. This sham mobilization mimics the manual therapy without targeting the affected area or following the algorithm's logic.", 'armGroupLabels': ['Non specific manual therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sebastien MARTIN, PT, MSc', 'role': 'CONTACT', 'email': 's.urfamartin@gmail.com', 'phone': '0612729653', 'phoneExt': '+33'}, {'name': 'Romain ARTICO, PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'valerie VACHER', 'role': 'STUDY_CHAIR', 'affiliation': 'DRCI-AP-HP, Saint-Louis Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}