Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-25 @ 12:59 PM
Study NCT ID:
NCT07241559
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Thoracolumbar Fascia Mobilization and Ultrasound-Guided Thoracolumbar Interfascial 5% Dextrose Injection in Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D000089803', 'term': 'Myofascial Release Therapy'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, after 1 month and 3 month changes', 'description': "Patients' back pain scores will be recorded using a VAS (Visual Analog Scale). The VAS method used to assess pain intensity is a scale from 0 (no pain) to 10 (unbearable pain), with the patient selecting the number that corresponds to their pain."}, {'measure': 'Lumbar spine range of motion (ROM)', 'timeFrame': 'Baseline, after 1 month and 3 month changes', 'description': 'Lumbar spine range of motion (ROM) was evaluated using both a dual digital inclinometer and the Modified Schober Test.\n\nFor the inclinometer assessment, a dual digital inclinometer (Baseline® Digital Inclinometer, Fabrication Enterprises Inc., USA) was used. Participants were positioned in a standing posture with feet shoulder-width apart and knees fully extended. The spinous processes of T12 and S1 vertebrae were palpated and marked as anatomical reference points.\n\nTwo inclinometers were placed over these landmarks-one at T12 and one at S1-and both were zeroed in the neutral position. Participants were instructed to perform lumbar flexion, extension, and lateral flexion slowly without bending the knees or rotating the pelvis.\n\nThe lumbar ROM for each direction was calculated as the difference between the angular readings at T12 and S1 levels. Each movement was measured three times, and the mean value was used for analysis.\n\nAdditionally, lumbar flexion was also assessed using the Modif'}, {'measure': 'Functional Status Assessment (Oswestry Disability Index - ODI)', 'timeFrame': 'Baseline, after 1 month and 3 month changes', 'description': 'Functional status was assessed using the Oswestry Disability Index (ODI), one of the most commonly used and validated questionnaires for evaluating disability related to low back pain.\n\nThe ODI consists of 10 sections, each addressing a different aspect of daily living affected by back pain, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment or homemaking.\n\nEach item is scored on a 6-point Likert scale ranging from 0 (no disability) to 5 (maximum disability).\n\nThe total score is calculated by summing the responses, dividing by the maximum possible score, and multiplying by 100 to obtain a percentage of disability.\n\nHigher scores indicate greater functional limitation.\n\nParticipants completed the ODI questionnaire at baseline and after the intervention to assess changes in functional status over time.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Assessment (SF-12 Health Survey)', 'timeFrame': 'Baseline, after 1 month and 3 month changes', 'description': 'Quality of life was assessed using the 12-Item Short Form Health Survey (SF-12), a validated and widely used self-reported questionnaire designed to evaluate overall health status.\n\nThe SF-12 measures both physical and mental health components, summarized as the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.\n\nParticipants completed the SF-12 questionnaire at baseline and after the intervention. Each item was scored according to the standardized SF-12 scoring algorithm, and results were converted into normalized scores (mean = 50, SD = 10) to allow comparison with general population norms.\n\nHigher scores indicate better perceived health status and quality of life. The SF-12 has been validated for use in musculoskeletal and chronic pain populations and is suitable for evaluating treatment-related changes in functional health and well-being.'}, {'measure': 'Thoracolumbar Fascia Thickness and Echogenicity Assessment', 'timeFrame': 'Baseline, after 1 month and 3 month changes', 'description': 'Thoracolumbar fascia (TLF) morphology was evaluated using ultrasound imaging, following the methodology described by Langevin et al. The ultrasound probe was positioned transversely at the L2-L3 interspinous level, where the thoracolumbar fascia lies parallel to the skin surface.\n\nHigh-resolution B-mode ultrasound images of the thoracolumbar fascia were obtained and recorded for each participant under standardized conditions.\n\nThe thickness and echogenicity of the fascia were analyzed using ImageJ® software (National Institutes of Health, USA), a freely available image processing program.\n\nFascial thickness was measured as the distance between the superficial and deep fascial borders, and echogenicity was quantified using grayscale intensity analysis within a standardized region of interest (ROI).\n\nAll ultrasound assessments were performed by the same experienced physiatrist to ensure measurement reliability.'}, {'measure': 'Lumbar Proprioception Assessment', 'timeFrame': 'Baseline, after 1 month and 3 month changes', 'description': 'Lumbar proprioception was evaluated using an active joint position sense test performed in the sitting position.\n\nParticipants were seated comfortably with their pelvis stabilized and were instructed to move their trunk from a neutral starting position to a predetermined target angle in the sagittal plane (flexion or extension).\n\nAfter reaching the target position, participants maintained the posture for a few seconds to familiarize themselves with it, then returned to the starting (neutral) position.\n\nFollowing three practice trials involving maximal flexion and extension, each participant was asked to reproduce the target position without visual feedback.\n\nThe repositioning error-the difference between the target angle and the angle reproduced by the participant-was measured using a universal goniometer.\n\nThree measurements were obtained, and the mean repositioning error was recorded for analysis.\n\nSmaller errors indicated better proprioceptive accuracy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dextrose Injection', 'Mobilization', 'Thoracolumbar Fascia'], 'conditions': ['Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '21929806', 'type': 'BACKGROUND', 'citation': 'Langevin HM, Fox JR, Koptiuch C, Badger GJ, Greenan-Naumann AC, Bouffard NA, Konofagou EE, Lee WN, Triano JJ, Henry SM. Reduced thoracolumbar fascia shear strain in human chronic low back pain. BMC Musculoskelet Disord. 2011 Sep 19;12:203. doi: 10.1186/1471-2474-12-203.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of thoracolumbar fascia mobilization and ultrasound-guided thoracolumbar interfascial 5% dextrose injection on pain, range of motion, disability, quality of life, proprioception, and fascial thickness and echogenicity in patients with nonspecific chronic low back pain.\n\n-Primary Objective: The primary objective is to evaluate the effects of these interventions on pain, functional status and range of motion.\n\n-Secondary Objective: The secondary objective is to assess the long-term effects on quality of life, proprioception, fascial thickness, and echogenicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients aged 18 to 65 years\n2. Presence of low back pain lasting longer than 3 months\n3. No adequate response to medical treatment\n4. Voluntary participation in the study\n\nExclusion Criteria:\n\n1. Age below 18 or above 65 years\n2. Body mass index (BMI) greater than 30 kg/m²\n3. Pregnancy or breastfeeding\n4. Presence of coagulation disorders\n5. History of spinal surgery\n6. Presence of inflammatory or malignant diseases\n7. Local infection at the spine or injection site\n8. Presence of lumbar disc pathology causing radiculopathy\n9. Presence of spinal stenosis, spondylolysis, or spondylolisthesis\n10. Participation in physical therapy or any manual therapy within the past 6 months\n11. Receiving lumbar injections within the past 6 months\n12. History of allergy to injection materials\n13. Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT07241559', 'briefTitle': 'Comparison of the Effectiveness of Thoracolumbar Fascia Mobilization and Ultrasound-Guided Thoracolumbar Interfascial 5% Dextrose Injection in Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of the Effectiveness of Thoracolumbar Fascia Mobilization and Ultrasound-Guided Thoracolumbar Interfascial 5% Dextrose Injection in Patients With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': '2025/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracolumbar Fascia Mobilization Group', 'description': 'Patients in this group will receive thoracolumbar fascia mobilization. A total of six sessions of myofascial release therapy will be administered twice per week for three weeks.', 'interventionNames': ['Procedure: Myofascial Release']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracolumbar Interfascial 5% Dextrose Injection Group', 'description': 'Patients in this group will receive ultrasound-guided thoracolumbar interfascial 5% dextrose injection.\n\nAfter being informed about the procedure, the patient will be placed in the prone position on the examination table, with a small pillow placed under the abdomen to allow relaxation of the lumbar muscles.\n\nAxial scanning will be performed using a Logiq 9 (GE Medical Systems®) ultrasound device equipped with a linear probe (7-12 MHz, "ZONARE"), and the probe will be positioned at the level of the L3 spinous process. The multifidus, longissimus, and iliocostalis muscles will be visualized.\n\nA 21-gauge (0.80 × 38 mm) needle will then be inserted from lateral to medial into the interfascial plane of the posterior layer of the thoracolumbar fascia using an in-plane technique. After confirming negative aspiration (to rule out vascular puncture), 10 mL of 5% dextrose solution will be injected into the target area.', 'interventionNames': ['Drug: 5% Dextrose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined Therapy Group', 'description': 'Patients in this group will receive both myofascial release therapy and ultrasound-guided thoracolumbar interfascial 5% dextrose injection as described above.', 'interventionNames': ['Drug: 5% Dextrose', 'Procedure: Myofascial Release']}], 'interventions': [{'name': '5% Dextrose', 'type': 'DRUG', 'description': '10 mL of 5% dextrose solution will be injected into the target area.', 'armGroupLabels': ['Combined Therapy Group', 'Thoracolumbar Interfascial 5% Dextrose Injection Group']}, {'name': 'Myofascial Release', 'type': 'PROCEDURE', 'description': 'Patients in this group will receive thoracolumbar fascia mobilization. A total of six sessions of myofascial release therapy will be administered twice per week for three weeks.', 'armGroupLabels': ['Combined Therapy Group', 'Thoracolumbar Fascia Mobilization Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'state': 'Altındağ', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Büşra ALÇIN, Medical Doctor', 'role': 'CONTACT', 'email': 'drbusraalcin@gmail.com', 'phone': '+905413528952'}, {'name': 'Barış NACIR, Professor Doctor', 'role': 'CONTACT', 'email': 'drbarisnacir@gmail.com', 'phone': '+905327278724'}, {'name': 'Büşra ALÇIN, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nida KOÇER NAZLIGÜL, Medical Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Barış NACIR, Professor Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ankara Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Barış NACIR, Professor Doctor', 'role': 'CONTACT', 'email': 'drbarisnacir@gmail.com', 'phone': '+905327278724'}, {'name': 'Büşra ALÇIN, Medical Doctor', 'role': 'CONTACT', 'email': 'drbusraalcin@gmail.com', 'phone': '+905413528952'}], 'overallOfficials': [{'name': 'Büşra ALÇIN, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Training and Research Hospital'}, {'name': 'Nida KOÇER NAZLIGÜL, Medical Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara Training and Research Hospital'}, {'name': 'Barış NACIR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara Training and Research Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}