Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT05096806
Status:
UNKNOWN
Last Update Posted:
2021-10-27
First Post:
2021-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-10-14', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Pain at post intervention', 'timeFrame': 'At the end of the intervention, at the 4th week of the study', 'description': 'Pain will be assessed using the visual analogue scale (VAS)'}, {'measure': 'Change from Baseline Knee function at postintervention', 'timeFrame': 'At the end of the intervention, at the 4th week of the study', 'description': 'Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)'}, {'measure': 'Change from Baseline Quality of life at postintervention', 'timeFrame': 'At the end of the intervention, at the 4th week of the study', 'description': 'Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Pain at 4 months', 'timeFrame': '16 weeks afther the end of the intervention, at the 20th week of the study', 'description': 'Pain will be assessed using the visual analogue scale (VAS)'}, {'measure': 'Change from Baseline Knee function at 4 months', 'timeFrame': '16 weeks afther the end of the intervention, at the 20th week of the study', 'description': 'Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)'}, {'measure': 'Change from Baseline Quality of life at 4 months', 'timeFrame': '16 weeks afther the end of the intervention, at the 20th week of the study', 'description': 'Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.'}, {'measure': 'Drug intake postintervention', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Rescue drug intake will be collected in the data collection notebooks'}, {'measure': 'Adverse events postintervention', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Any adverse event related with the treatments will be will be noted in a collection sheet.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupuncture', 'Osteoarthritis, Knee'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '26439406', 'type': 'BACKGROUND', 'citation': 'Roos EM, Arden NK. Strategies for the prevention of knee osteoarthritis. Nat Rev Rheumatol. 2016 Feb;12(2):92-101. doi: 10.1038/nrrheum.2015.135. Epub 2015 Oct 6.'}, {'pmid': '29198932', 'type': 'BACKGROUND', 'citation': "Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2."}, {'pmid': '28267751', 'type': 'BACKGROUND', 'citation': 'Woods B, Manca A, Weatherly H, Saramago P, Sideris E, Giannopoulou C, Rice S, Corbett M, Vickers A, Bowes M, MacPherson H, Sculpher M. Cost-effectiveness of adjunct non-pharmacological interventions for osteoarthritis of the knee. PLoS One. 2017 Mar 7;12(3):e0172749. doi: 10.1371/journal.pone.0172749. eCollection 2017.'}, {'pmid': '24761164', 'type': 'BACKGROUND', 'citation': 'Cao H, Bourchier S, Liu J. Does Syndrome Differentiation Matter? A Meta-Analysis of Randomized Controlled Trials in Cochrane Reviews of Acupuncture. Med Acupunct. 2012 Jun;24(2):68-76. doi: 10.1089/acu.2011.0846.'}, {'pmid': '31305415', 'type': 'BACKGROUND', 'citation': 'Li J, Li YX, Luo LJ, Ye J, Zhong DL, Xiao QW, Zheng H, Geng CM, Jin RJ, Liang FR. The effectiveness and safety of acupuncture for knee osteoarthritis: An overview of systematic reviews. Medicine (Baltimore). 2019 Jul;98(28):e16301. doi: 10.1097/MD.0000000000016301.'}]}, 'descriptionModule': {'briefSummary': "Introduction:\n\nKnee osteoarthritis is a long-term rheumatic disease with a significant impact on the patient's quality of life and the socio-economic development of societies. The usual treatment consists of non-steroidal anti-inflammatory drugs as a palliative measure. The decrease in the beneficial effect and the appearance of serious long-term adverse effects make it necessary to look for other therapeutic procedures. Acupuncture is a non-pharmacological treatment that could reduce pain and improve functionality in this condition, however current scientific evidence is limited. A previous study has observed a clinical improvement in the combination of sensitized local and peripheral points in the treatment of knee osteoarthritis but studies with a larger sample are needed to confirm these results.\n\nObjective:\n\nAssess the effectiveness of acupuncture using a combination of local and peripheral sensitized points in the treatment of active knee osteoarthritis.\n\nMethods:\n\nA randomized clinical trial will be performed in a hospital centre with 2 groups. The control group will standard treatment plus transcutaneous electrical nerve stimulation, while the intervention group will receive acupuncture in addition to standard care. Study outcomes will be pain, quality of life, function, exercise adherence, drug intake, adverse effects, and body mass index. There will be a 12-month post-intervention follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Usual painful episode of 3 months or more\n* Morning stiffness of 15 minutes or more\n* Pain equal to or greater than 5 on the VAS\n* Grade 2 or greater on the Kellgren-Lawrence scale\n\nExclusion Criteria:\n\n* Corticosteroid infiltration in the 3 months prior to recruitment\n* Rehabilitation treatment one month prior to recruitment\n* With a knee prosthesis\n* Needle phobia\n* Pregnancy\n* With pacemakers\n* Cardiac arrhythmias'}, 'identificationModule': {'nctId': 'NCT05096806', 'briefTitle': 'Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universitat de Girona'}, 'officialTitle': 'Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEBRU0021-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care plus TENS', 'description': 'Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) and usual care.\n\nTENS treatment will perform in the region of the knee and the extensor muscles for 20 minutes, 2 times a week. 4 electrodes will be placed, 2 on the proximal region of the internal and external vastus, and the other 2 on the distal region of the motor plate.\n\nUsual care will consist in home exercises with toning exercises of the extensor apparatus, pelvic region and musculoskeletal stretching exercises of 2 weekly sessions, the recommendation of daily activity of walking for 1 hour daily as an active lifestyle and the recommendation of the reduction of body weight in the case of being above normal weight. There will be a total of 6 face-to-face sessions at the rate of 2 weekly sessions', 'interventionNames': ['Device: TENS']}, {'type': 'EXPERIMENTAL', 'label': 'Usual care plus Acupuncture', 'description': 'Participants in this group will receive acupuncture treatment and usual care.\n\nAcupuncture treatment will consist in 20-minute semi-standardized acupuncture sessions, 2 times a week. The intervention will consist of the insertion of 8 needles: 4 in points located in the knee (points St34, St35, XiYan and Sp10) and 4 more sensitive to palpation points located between the knee and the ankle. Stimulation will be performed to obtain local spasm response, the needles will be left for 20 minutes and then removed. The needles will be sterile disposable silicone needles of 0.20x20mm and 0.20x40mm.\n\nUsual care will be the same described in the Usual care plus TENS group', 'interventionNames': ['Other: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'Acupuncture is a non-pharmacological technique that consists in the stimulation of specific points located in the skin surface. Points are stimulated by piercing the skin with fine needles.', 'armGroupLabels': ['Usual care plus Acupuncture']}, {'name': 'TENS', 'type': 'DEVICE', 'otherNames': ['Transcutaneous electrical nerve stimulation'], 'description': 'TENS is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.', 'armGroupLabels': ['Usual care plus TENS']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tomás Tegiacchi', 'role': 'CONTACT', 'email': 'tomasjtg@gmail.com', 'phone': '0034676364399'}, {'name': 'Carles Fernández', 'role': 'CONTACT', 'email': 'carlesfj@blanquerna.url.edu', 'phone': '0034651503494'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat de Girona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tomás Tegiacchi', 'investigatorAffiliation': 'Universitat de Girona'}}}}