- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02699411
Dry Needling-effektivitet hos patienter ved brud på forreste korsbånd. (ACL)
Dry Needling-effektivitet hos patienter ved brud på forreste korsbånd. Enkelt-blind randomiseret klinisk forsøg.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Det udfører en sidste femten dage ECA kirurgisk rekonstruktion af det forreste korsbånd. Tyve individer i en gruppe, der skulle udsættes for en teknik med fysioterapi, dry needling blev inkluderet. (Gruppe A). En anden gruppe på tyve patienter behandlet med konservativ behandling udførte en stabilitetsøvelse og proprioception (Gruppe B). 46 patienter vil blive undersøgt. Ingen var tidligere blevet opereret på grund af ustabilitet i leddene, og alle forsøgspersoner blev tidligere udsat for en diagnostisk undersøgelse med kernemagnetisk resonans før operationen, og diagnosen blev bekræftet ved yderligere diagnostisk test. Alle patienter vil blive evalueret af en fysioterapeut, og Myofascial Trigger Point (PGM) af vastusmusklen vil blive evalueret.
patienter, der bruger følgende variabler, evalueres:
- Smerte: Visual Analog Scale (VAS) blev brugt.
- Stivhed og fysisk funktion ved hjælp af WOMAC-skalaen (The Western Ontario and McMaster Universities Arthritis Index.).
- Knæleddets bevægelsesområde: Skala ROM.
- Muskelstyrke, balance og propiocepción: Star Excursion by Balance Scale Test.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Madrid, Spanien
- Rekruttering
- Jorge Velázquez Saornil
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Kontakt:
- Jorge Velázquez, Mr
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Kontakt:
- Jorge Velázquez
- E-mail: jorgevelasa@yahoo.es
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Ledende efterforsker:
- Jorge Velázquez, Mr
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Underforsker:
- Beatriz Ruiz, Mrs
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Underforsker:
- César Calvo, Mr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- over atten og anatomisk moden bryde kirurgisk LCA og vurderet ovenfor ved hjælp af MR og funktionelle tests for at bekræfte ruptur af ledbåndet.
Ekskluderingskriterier:
- Patienter, der ikke nåede 18 år og personer over 55,
- postoperative komplikationer
- forårsage myofascial eller neuropatisk smerte i underekstremiteterne, som lumba-sakral radikulopati, neuropraxia, neurotmesis, axonotmesis eller meralgia paresthetica;
- fibromyalgi.
- hypothyroidisme
- jernmangel og patienter, der havde nåleskræk (frygt for nåle).
- Forskelle i underekstremiteterne.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: dry needling
Dry needling på vastus udføres hos patienter, der gennemgår ACL fjorten dage efter interventionen og evalueres derefter.
REL dry needling, mens forsyningerne varer 20 indsættelser før behandling, ved midnat, en uge og fem uger.
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dry needling Travell og Simons
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Aktiv komparator: Stabilitet og propioception
Proprioception og stabilitetsøvelser hos patienter, der gennemgår ACL fjorten dage efter interventionen og derefter evalueringer udført før behandling, ved midnat, en uge og fem uger.
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Start udflugtsbalancetest, WOMAC; ROM, EVA.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Bevægelsesområde (ROM)
Tidsramme: 24 timer
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24 timer
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Resultater fra Western Ontario og McMaster Universities Arthritis Index (WOMAC)
Tidsramme: 24 timer
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24 timer
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Smertescore visuel analog skala (EVA)
Tidsramme: 24 timer
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24 timer
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Resultater af STAR BALANCE TEST
Tidsramme: 24
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24
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Bevægelsesområde (ROM)
Tidsramme: En uge
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En uge
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Bevægelsesområde (ROM)
Tidsramme: 5 uger
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5 uger
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Resultater fra Western Ontario og McMaster Universities Arthritis Index (WOMAC)
Tidsramme: En uge
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En uge
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Resultater fra Western Ontario og McMaster Universities Arthritis Index (WOMAC)
Tidsramme: 5 uger
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5 uger
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Smertescore visuel analog skala (EVA)
Tidsramme: En uge
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En uge
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Smertescore visuel analog skala (EVA)
Tidsramme: 5 uger
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5 uger
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Scorer STJERNEBALANCETEST
Tidsramme: En uge
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En uge
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Scorer STJERNEBALANCETEST
Tidsramme: 5 uger
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5 uger
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jorge Velázquez, Sr, European University
Publikationer og nyttige links
Generelle publikationer
- Garvey TA, Marks MR, Wiesel SW. A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain. Spine (Phila Pa 1976). 1989 Sep;14(9):962-4. doi: 10.1097/00007632-198909000-00008.
- Tekin L, Akarsu S, Durmus O, Cakar E, Dincer U, Kiralp MZ. The effect of dry needling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial. Clin Rheumatol. 2013 Mar;32(3):309-15. doi: 10.1007/s10067-012-2112-3. Epub 2012 Nov 9.
- Domingo A, Mayoral O, Monterde S, Santafe MM. Neuromuscular damage and repair after dry needling in mice. Evid Based Complement Alternat Med. 2013;2013:260806. doi: 10.1155/2013/260806. Epub 2013 Apr 9.
- Krosshaug T, Nakamae A, Boden BP, Engebretsen L, Smith G, Slauterbeck JR, Hewett TE, Bahr R. Mechanisms of anterior cruciate ligament injury in basketball: video analysis of 39 cases. Am J Sports Med. 2007 Mar;35(3):359-67. doi: 10.1177/0363546506293899. Epub 2006 Nov 7.
- Martin-Pintado Zugasti A, Rodriguez-Fernandez AL, Garcia-Muro F, Lopez-Lopez A, Mayoral O, Mesa-Jimenez J, Fernandez-Carnero J. Effects of spray and stretch on postneedling soreness and sensitivity after dry needling of a latent myofascial trigger point. Arch Phys Med Rehabil. 2014 Oct;95(10):1925-1932.e1. doi: 10.1016/j.apmr.2014.05.021. Epub 2014 Jun 10.
- Pecos-Martin D, Montanez-Aguilera FJ, Gallego-Izquierdo T, Urraca-Gesto A, Gomez-Conesa A, Romero-Franco N, Plaza-Manzano G. Effectiveness of dry needling on the lower trapezius in patients with mechanical neck pain: a randomized controlled trial. Arch Phys Med Rehabil. 2015 May;96(5):775-81. doi: 10.1016/j.apmr.2014.12.016. Epub 2015 Jan 9.
- Caraffa A, Cerulli G, Projetti M, Aisa G, Rizzo A. Prevention of anterior cruciate ligament injuries in soccer. A prospective controlled study of proprioceptive training. Knee Surg Sports Traumatol Arthrosc. 1996;4(1):19-21. doi: 10.1007/BF01565992.
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- Saka T. Principles of postoperative anterior cruciate ligament rehabilitation. World J Orthop. 2014 Sep 18;5(4):450-9. doi: 10.5312/wjo.v5.i4.450. eCollection 2014 Sep 18.
- Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.
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- Ahn JH, Chang MJ, Lee YS, Koh KH, Park YS, Eun SS. Non-operative treatment of ACL rupture with mild instability. Arch Orthop Trauma Surg. 2010 Aug;130(8):1001-6. doi: 10.1007/s00402-010-1077-4. Epub 2010 Mar 25.
- Alentorn-Geli E, Myer GD, Silvers HJ, Samitier G, Romero D, Lazaro-Haro C, Cugat R. Prevention of non-contact anterior cruciate ligament injuries in soccer players. Part 1: Mechanisms of injury and underlying risk factors. Knee Surg Sports Traumatol Arthrosc. 2009 Jul;17(7):705-29. doi: 10.1007/s00167-009-0813-1. Epub 2009 May 19.
- Baltaci G, Harput G, Haksever B, Ulusoy B, Ozer H. Comparison between Nintendo Wii Fit and conventional rehabilitation on functional performance outcomes after hamstring anterior cruciate ligament reconstruction: prospective, randomized, controlled, double-blind clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 Apr;21(4):880-7. doi: 10.1007/s00167-012-2034-2. Epub 2012 Apr 29.
- Sbihi A, Franceschi JP, Christel P, Colombet P, Djian P, Bellier G. [Anterior cruciate ligament reconstruction: biomechanical comparison on cadaver specimens using a single or double hamstring technique]. Rev Chir Orthop Reparatrice Appar Mot. 2004 Nov;90(7):643-50. doi: 10.1016/s0035-1040(04)70725-4. French.
- Cimino F, Volk BS, Setter D. Anterior cruciate ligament injury: diagnosis, management, and prevention. Am Fam Physician. 2010 Oct 15;82(8):917-22.
- Delince P, Ghafil D. Anterior cruciate ligament tears: conservative or surgical treatment? Knee Surg Sports Traumatol Arthrosc. 2013 Jul;21(7):1706-7. doi: 10.1007/s00167-012-2134-z. Epub 2012 Jul 13. No abstract available.
- Diekstall P, Rauhut F. [Considerations for the indications for anterior cruciate ligament reconstruction. Results of conservative versus operative treatment]. Unfallchirurg. 1999 Mar;102(3):173-81. doi: 10.1007/s001130050390. German.
- Dommerholt J. Dry needling - peripheral and central considerations. J Man Manip Ther. 2011 Nov;19(4):223-7. doi: 10.1179/106698111X13129729552065.
- Fithian DC, Paxton EW, Stone ML, Luetzow WF, Csintalan RP, Phelan D, Daniel DM. Prospective trial of a treatment algorithm for the management of the anterior cruciate ligament-injured knee. Am J Sports Med. 2005 Mar;33(3):335-46. doi: 10.1177/0363546504269590.
- Fitzgerald GK, Axe MJ, Snyder-Mackler L. The efficacy of perturbation training in nonoperative anterior cruciate ligament rehabilitation programs for physical active individuals. Phys Ther. 2000 Feb;80(2):128-40.
- Friederich NF, O'Brien WR. [Gonarthrosis after injury of the anterior cruciate ligament: a multicenter, long-term study]. Z Unfallchir Versicherungsmed. 1993;86(2):81-9. German.
- Gelb HJ, Glasgow SG, Sapega AA, Torg JS. Magnetic resonance imaging of knee disorders. Clinical value and cost-effectiveness in a sports medicine practice. Am J Sports Med. 1996 Jan-Feb;24(1):99-103. doi: 10.1177/036354659602400118.
- Basdekis G, Christel P, Anne F. Validation of the position of the femoral tunnels in anatomic double-bundle ACL reconstruction with 3-D CT scan. Knee Surg Sports Traumatol Arthrosc. 2009 Sep;17(9):1089-94. doi: 10.1007/s00167-009-0829-6. Epub 2009 Jun 13.
- Harris JD, Erickson BJ, Bach BR Jr, Abrams GD, Cvetanovich GL, Forsythe B, McCormick FM, Gupta AK, Cole BJ. Return-to-Sport and Performance After Anterior Cruciate Ligament Reconstruction in National Basketball Association Players. Sports Health. 2013 Nov;5(6):562-8. doi: 10.1177/1941738113495788.
- Jinks C, Jordan K, Croft P. Measuring the population impact of knee pain and disability with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Pain. 2002 Nov;100(1-2):55-64. doi: 10.1016/s0304-3959(02)00239-7.
- Johnson RJ, Beynnon BD. What do we really know about rehabilitation after ACL reconstruction?: commentary on an article by L.M. Kruse, MD, et al.: "rehabilitation after anterior cruciate ligament reconstruction. a systematic review". J Bone Joint Surg Am. 2012 Oct 3;94(19):e148(1-2). doi: 10.2106/JBJS.L.00947. No abstract available.
- Lephart SM, Pincivero DM, Giraldo JL, Fu FH. The role of proprioception in the management and rehabilitation of athletic injuries. Am J Sports Med. 1997 Jan-Feb;25(1):130-7. doi: 10.1177/036354659702500126.
- Li G, DeFrate LE, Sun H, Gill TJ. In vivo elongation of the anterior cruciate ligament and posterior cruciate ligament during knee flexion. Am J Sports Med. 2004 Sep;32(6):1415-20. doi: 10.1177/0363546503262175. Epub 2004 Jul 20.
- Orishimo KF, Liederbach M, Kremenic IJ, Hagins M, Pappas E. Comparison of landing biomechanics between male and female dancers and athletes, part 1: Influence of sex on risk of anterior cruciate ligament injury. Am J Sports Med. 2014 May;42(5):1082-8. doi: 10.1177/0363546514523928. Epub 2014 Mar 3.
- Liu-Ambrose T, Taunton JE, MacIntyre D, McConkey P, Khan KM. The effects of proprioceptive or strength training on the neuromuscular function of the ACL reconstructed knee: a randomized clinical trial. Scand J Med Sci Sports. 2003 Apr;13(2):115-23. doi: 10.1034/j.1600-0838.2003.02113.x.
- Livesay GA, Rudy TW, Woo SL, Runco TJ, Sakane M, Li G, Fu FH. Evaluation of the effect of joint constraints on the in situ force distribution in the anterior cruciate ligament. J Orthop Res. 1997 Mar;15(2):278-84. doi: 10.1002/jor.1100150218.
- Lohmander LS, Ostenberg A, Englund M, Roos H. High prevalence of knee osteoarthritis, pain, and functional limitations in female soccer players twelve years after anterior cruciate ligament injury. Arthritis Rheum. 2004 Oct;50(10):3145-52. doi: 10.1002/art.20589.
- Maletius W, Gillquist J. Long-term results of anterior cruciate ligament reconstruction with a Dacron prosthesis. The frequency of osteoarthritis after seven to eleven years. Am J Sports Med. 1997 May-Jun;25(3):288-93. doi: 10.1177/036354659702500303.
- Mandelbaum BR, Silvers HJ, Watanabe DS, Knarr JF, Thomas SD, Griffin LY, Kirkendall DT, Garrett W Jr. Effectiveness of a neuromuscular and proprioceptive training program in preventing anterior cruciate ligament injuries in female athletes: 2-year follow-up. Am J Sports Med. 2005 Jul;33(7):1003-10. doi: 10.1177/0363546504272261. Epub 2005 May 11.
- Mayoral O, Salvat I, Martin MT, Martin S, Santiago J, Cotarelo J, Rodriguez C. Efficacy of myofascial trigger point dry needling in the prevention of pain after total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Evid Based Complement Alternat Med. 2013;2013:694941. doi: 10.1155/2013/694941. Epub 2013 Mar 27.
- Myklebust G, Engebretsen L, Braekken IH, Skjolberg A, Olsen OE, Bahr R. Prevention of noncontact anterior cruciate ligament injuries in elite and adolescent female team handball athletes. Instr Course Lect. 2007;56:407-18.
- Ordahan B, Kucuksen S, Tuncay I, Salli A, Ugurlu H. The effect of proprioception exercises on functional status in patients with anterior cruciate ligament reconstruction. J Back Musculoskelet Rehabil. 2015;28(3):531-7. doi: 10.3233/BMR-140553.
- Postle K, Pak D, Smith TO. Effectiveness of proprioceptive exercises for ankle ligament injury in adults: a systematic literature and meta-analysis. Man Ther. 2012 Aug;17(4):285-91. doi: 10.1016/j.math.2012.02.016. Epub 2012 Mar 27.
- Prodromos CC, Han Y, Rogowski J, Joyce B, Shi K. A meta-analysis of the incidence of anterior cruciate ligament tears as a function of gender, sport, and a knee injury-reduction regimen. Arthroscopy. 2007 Dec;23(12):1320-1325.e6. doi: 10.1016/j.arthro.2007.07.003.
- Relph N, Herrington L, Tyson S. The effects of ACL injury on knee proprioception: a meta-analysis. Physiotherapy. 2014 Sep;100(3):187-95. doi: 10.1016/j.physio.2013.11.002. Epub 2013 Dec 4.
- Salom-Moreno J, Ayuso-Casado B, Tamaral-Costa B, Sanchez-Mila Z, Fernandez-de-Las-Penas C, Alburquerque-Sendin F. Trigger Point Dry Needling and Proprioceptive Exercises for the Management of Chronic Ankle Instability: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:790209. doi: 10.1155/2015/790209. Epub 2015 Apr 30.
- Villanueva I, del Mar Guzman M, Javier Toyos F, Ariza-Ariza R, Navarro F. Relative efficiency and validity properties of a visual analogue vs a categorical scaled version of the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index: Spanish versions. Osteoarthritis Cartilage. 2004 Mar;12(3):225-31. doi: 10.1016/j.joca.2003.11.006.
- Vrbanic TS, Ravlic-Gulan J, Gulan G, Matovinovic D. Balance index score as a predictive factor for lower sports results or anterior cruciate ligament knee injuries in Croatian female athletes--preliminary study. Coll Antropol. 2007 Mar;31(1):253-8.
- Wasmaier J, Kubik-Huch R, Pfirrmann C, Grehn H, Bieg C, Eid K. Proximal anterior cruciate ligament tears: the healing response technique versus conservative treatment. J Knee Surg. 2013 Aug;26(4):263-71. doi: 10.1055/s-0032-1329720. Epub 2012 Dec 20.
- Bron C, de Gast A, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. Treatment of myofascial trigger points in patients with chronic shoulder pain: a randomized, controlled trial. BMC Med. 2011 Jan 24;9:8. doi: 10.1186/1741-7015-9-8.
- Mason JS, Tansey KA, Westrick RB. Treatment of subacute posterior knee pain in an adolescent ballet dancer utilizing trigger point dry needling: a case report. Int J Sports Phys Ther. 2014 Feb;9(1):116-24.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- European University
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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