Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-07 @ 12:18 AM
Study NCT ID:
NCT03821194
Status:
UNKNOWN
Last Update Posted:
2019-06-11
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'chronic knee joint pain patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-08', 'studyFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2019-01-27', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': '10 Days', 'description': 'To assess the pain degree. Scale: 0\\~100 mm, higher scores, higher pain . Counted by each time recording.'}, {'measure': 'Lower Extremity Functional Scale', 'timeFrame': '10 Days', 'description': 'Evaluate the functional impairment of a patient with a disorder of one or both lower extremities.\n\nScale: 0\\~80, higher scores, higher lower extremity function Counted by each time recording.'}, {'measure': 'Short Form-12 Health Survey', 'timeFrame': '3 Days', 'description': 'Evaluate the health-related quality of life, use SF-12 questionnaire. Scale: 0\\~100, higher scores, better life quality. Counted by each time recording and using mode conversion to get final scale.'}], 'secondaryOutcomes': [{'measure': 'Ultrasound scans of knee', 'timeFrame': '3 Days', 'description': 'To observe the tissue of knee joint, compare quadriceps muscle changes and tendon thickness before and after treatment.\n\nNo special measure, just take picture of ultrasound scans and compare the picture.'}, {'measure': 'surface temperature', 'timeFrame': '2 hours', 'description': 'To evaluate the knee joint surface temperature before and after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain relief', 'complementary and alternative therapy'], 'conditions': ['Pain, Chronic']}, 'referencesModule': {'references': [{'pmid': '28795010', 'type': 'BACKGROUND', 'citation': 'Patel DR, Villalobos A. Evaluation and management of knee pain in young athletes: overuse injuries of the knee. Transl Pediatr. 2017 Jul;6(3):190-198. doi: 10.21037/tp.2017.04.05.'}, {'pmid': '22147711', 'type': 'BACKGROUND', 'citation': 'Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011 Dec 6;155(11):725-32. doi: 10.7326/0003-4819-155-11-201112060-00004.'}, {'pmid': '24997734', 'type': 'BACKGROUND', 'citation': 'Werner S. Anterior knee pain: an update of physical therapy. Knee Surg Sports Traumatol Arthrosc. 2014 Oct;22(10):2286-94. doi: 10.1007/s00167-014-3150-y. Epub 2014 Jul 6.'}, {'pmid': '23230089', 'type': 'BACKGROUND', 'citation': 'Iagnocco A, Naredo E. Osteoarthritis: research update and clinical applications. Rheumatology (Oxford). 2012 Dec;51 Suppl 7:vii2-5. doi: 10.1093/rheumatology/kes328.'}, {'pmid': '12605951', 'type': 'BACKGROUND', 'citation': 'Cowan DT, Fitzpatrick JM, Roberts JD, While AE, Baldwin J. The assessment and management of pain among older people in care homes: current status and future directions. Int J Nurs Stud. 2003 Mar;40(3):291-8. doi: 10.1016/s0020-7489(02)00087-1.'}, {'pmid': '24146995', 'type': 'BACKGROUND', 'citation': "MacPherson H, Maschino AC, Lewith G, Foster NE, Witt CM, Vickers AJ; Acupuncture Trialists' Collaboration. Characteristics of acupuncture treatment associated with outcome: an individual patient meta-analysis of 17,922 patients with chronic pain in randomised controlled trials. PLoS One. 2013 Oct 11;8(10):e77438. doi: 10.1371/journal.pone.0077438. eCollection 2013."}, {'type': 'BACKGROUND', 'citation': 'WHO. WHO Traditional Medicine Strategy 2014-2023. WHO Library Cataloguing-inPublication Data. 2013.'}, {'pmid': '15127982', 'type': 'BACKGROUND', 'citation': 'Sun C, Desai GJ, Pucci DS, Jew S. Musculoskeletal disorders: does the osteopathic medical profession demonstrate its unique and distinctive characteristics? J Am Osteopath Assoc. 2004 Apr;104(4):149-55.'}, {'pmid': '17905355', 'type': 'BACKGROUND', 'citation': 'Nielsen A, Knoblauch NT, Dobos GJ, Michalsen A, Kaptchuk TJ. The effect of Gua Sha treatment on the microcirculation of surface tissue: a pilot study in healthy subjects. Explore (NY). 2007 Sep-Oct;3(5):456-66. doi: 10.1016/j.explore.2007.06.001.'}, {'pmid': '19118794', 'type': 'BACKGROUND', 'citation': 'Nielsen A. Gua sha research and the language of integrative medicine. J Bodyw Mov Ther. 2009 Jan;13(1):63-72. doi: 10.1016/j.jbmt.2008.04.045. Epub 2008 Jul 17.'}, {'pmid': '3649128', 'type': 'BACKGROUND', 'citation': 'Hautman MA. Self-care responses to respiratory illnesses among Vietnamese. West J Nurs Res. 1987 May;9(2):223-43. doi: 10.1177/019394598700900205. No abstract available.'}, {'pmid': '21276190', 'type': 'BACKGROUND', 'citation': 'Braun M, Schwickert M, Nielsen A, Brunnhuber S, Dobos G, Musial F, Ludtke R, Michalsen A. Effectiveness of traditional Chinese "gua sha" therapy in patients with chronic neck pain: a randomized controlled trial. Pain Med. 2011 Mar;12(3):362-9. doi: 10.1111/j.1526-4637.2011.01053.x. Epub 2011 Jan 28.'}, {'pmid': '28619301', 'type': 'BACKGROUND', 'citation': 'Yuen JWM, Tsang WWN, Tse SHM, Loo WTY, Chan ST, Wong DLY, Chung HHY, Tam JKK, Choi TKS, Chiang VCL. The effects of Gua sha on symptoms and inflammatory biomarkers associated with chronic low back pain: A randomized active-controlled crossover pilot study in elderly. Complement Ther Med. 2017 Jun;32:25-32. doi: 10.1016/j.ctim.2017.03.010. Epub 2017 Mar 21.'}, {'pmid': '22928824', 'type': 'BACKGROUND', 'citation': 'Lauche R, Wubbeling K, Ludtke R, Cramer H, Choi KE, Rampp T, Michalsen A, Langhorst J, Dobos GJ. Randomized controlled pilot study: pain intensity and pressure pain thresholds in patients with neck and low back pain before and after traditional East Asian "gua sha" therapy. Am J Chin Med. 2012;40(5):905-17. doi: 10.1142/S0192415X1250067X.'}, {'pmid': '24187865', 'type': 'BACKGROUND', 'citation': 'Wang Y, Yang L, Yang J, Yang J, Liu Z, Chen F, Liu D, Yuan H, Wang L. Curative effect of scraping therapies on lumbar muscle strain. J Tradit Chin Med. 2013 Aug;33(4):455-60. doi: 10.1016/s0254-6272(13)60148-x.'}, {'pmid': '20220605', 'type': 'BACKGROUND', 'citation': 'Chiu JY, Gau ML, Kuo SY, Chang YH, Kuo SC, Tu HC. Effects of Gua-Sha therapy on breast engorgement: a randomized controlled trial. J Nurs Res. 2010 Mar;18(1):1-10. doi: 10.1097/JNR.0b013e3181ce4f8e.'}, {'pmid': '21616064', 'type': 'BACKGROUND', 'citation': 'Chan ST, Yuen JW, Gohel MD, Chung CP, Wong HC, Kwong KK. Guasha-induced hepatoprotection in chronic active hepatitis B: a case study. Clin Chim Acta. 2011 Aug 17;412(17-18):1686-8. doi: 10.1016/j.cca.2011.05.009. Epub 2011 May 13.'}, {'pmid': '25098257', 'type': 'BACKGROUND', 'citation': 'Tu WZ, Cheng RD, Hu J, Wang JZ, Lin HY, Zou EM, Wang WS, Lou XF, Jiang SH. Combination treatment with Gua Sha and Blood-letting causes attenuation of systemic inflammation, activated coagulation, tissue ischemia and injury during heatstroke in rats. Chin J Integr Med. 2015 Aug;21(8):610-7. doi: 10.1007/s11655-014-1816-4. Epub 2014 Aug 7.'}, {'pmid': '19718012', 'type': 'BACKGROUND', 'citation': 'Kwong KK, Kloetzer L, Wong KK, Ren JQ, Kuo B, Jiang Y, Chen YI, Chan ST, Young GS, Wong ST. Bioluminescence imaging of heme oxygenase-1 upregulation in the Gua Sha procedure. J Vis Exp. 2009 Aug 28;(30):1385. doi: 10.3791/1385.'}, {'pmid': '22462238', 'type': 'BACKGROUND', 'citation': 'Xu QY, Yang JS, Yang L, Wang YY. Effects of different scraping techniques on body surface blood perfusion volume and local skin temperature of healthy subjects. J Tradit Chin Med. 2011 Dec;31(4):316-20. doi: 10.1016/s0254-6272(12)60011-9.'}, {'pmid': '26554281', 'type': 'BACKGROUND', 'citation': 'Jones BQ, Covey CJ, Sineath MH Jr. Nonsurgical Management of Knee Pain in Adults. Am Fam Physician. 2015 Nov 15;92(10):875-83.'}, {'pmid': '24267149', 'type': 'BACKGROUND', 'citation': 'Simon LS. Nonsteroidal anti-inflammatory drugs and their risk: a story still in development. Arthritis Res Ther. 2013;15 Suppl 3(Suppl 3):S1. doi: 10.1186/ar4173. Epub 2013 Jul 24.'}, {'pmid': '10201543', 'type': 'BACKGROUND', 'citation': 'Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.'}]}, 'descriptionModule': {'briefSummary': "Objective:\n\nA randomized, single-blind, controlled clinical trial is conducted to evaluate the effect of gua sha on the relief of chronic knee joint area pain, and to investigate the association between local skin surface and core temperature changes with chronic pain relief over knee after gua sha. Also, we want to observe the changes before and after gua sha in the local tissues of the knee joint area. We expect to provide more insights into the relevant mechanism of gua sha and relieving pain in chronic knee joint area and establish a complementary therapy for chronic knee joint pain.\n\nMaterials and Methods:\n\nIn this study, a total of 40 chronic knee joint pain participants will be recruited in the eligible conditions. After agreeing into the clinical study and signing the informed consent form, they will be randomized assigned into the treatment group (20 persons) and control group (20 people). Both groups will be tested for total of 12 days. For treatment group, 2 times of gua sha method will be applied within 12-day test period, the treatments will be on the first day and the fourth day respectively. The control group will be applied 2 times of hot pack method at same period intervals during the 12 days. Both groups will be measured the surface and core temperature of the applied site before and after each method. The visual analog scale (VAS) and the lower extremity functional scale (LEFS) and SF-12 quality of life questionnaire will be performed before and after the test. Ultrasound scans of knee will be performed before and after the test. After the data collection is completed, the analysis is performed in SPSS version 24. Student's t-test and one-way ANOVA methods will be used, with P\\<0.05 as a significant result.\n\nExpected results:\n\nTo establish the positive effect of gua sha therapy to relieve the chronic knee joint pain, and use data and images to infer the mechanism of gua sha therapy on relieving chronic knee joint pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Those aged 20-60 years old\n2. There are at least three pains in the unilateral or bilateral knee joints (up and down steps, squats, running, squatting, jumping, walking, and sedentary for a long time), and the pain lasts for at least one month.\n3. Visual pain score (VAS) ≧30 (mm) for unilateral or bilateral knee joints\n4. Non-steroidal anti-inflammatory drugs, analgesics, and Chinese herbal medicines for the treatment of knee joint pain\n5. Non-severe degenerative arthritis (Kellgren-Lawrence scale knee arthritis grade 2 or less)\n\nExclusion Criteria:\n\n1. thighs, knee joints, calf areas, those who have undergone surgery or are expected to have surgery, those who have been traumatized within the last month, and those who have wounds, ulcers, infections or other skin diseases within two weeks\n2. Pregnancy\n3. BMI value is greater than 27 KG/m2\n4. People with cardiovascular disease or hemophilia\n5. Patients with gout, rheumatism and rheumatoid arthritis\n6. Diabetic patients with knee arthritis, patients with dry arthritis\n7. Patients with malignant tumors\n8. Those who are allergic to Vaseline products'}, 'identificationModule': {'nctId': 'NCT03821194', 'briefTitle': 'The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy', 'orgStudyIdInfo': {'id': '2018-08-030A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gua sha group', 'description': 'do gua sha for the subjects', 'interventionNames': ['Other: Gua sha']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'give hot pack for the subjects', 'interventionNames': ['Other: hot pack']}], 'interventions': [{'name': 'Gua sha', 'type': 'OTHER', 'description': 'Scrape the skin around the knee joint', 'armGroupLabels': ['Gua sha group']}, {'name': 'hot pack', 'type': 'OTHER', 'description': 'hot pack', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Fang-Pey Chen, MD', 'role': 'CONTACT'}], 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Fang-Pey Chen, MD', 'role': 'CONTACT', 'email': 'fpchen@vghtpe.gov.tw', 'phone': '+886-2-2875-7453'}], 'overallOfficials': [{'name': 'Fang-Pey Chen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Traditional Medicine, Taipei Veterans General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}