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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02699411
Other study ID # European University
Secondary ID
Status Recruiting
Phase N/A
First received February 26, 2016
Last updated March 1, 2016
Start date February 2016
Est. completion date September 2016

Study information

Verified date March 2016
Source European University Spain
Contact Jorge Velázquez, sr
Phone +34655909940
Email jorgevelasa@yahoo.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We will conduct a randomized clinical trial observing forty patients divided into two groups: one group composed of twenty individuals undergoing surgery for ruptured ACL, which perform dry needling of myofascial trigger (PGM) point of the vastus muscle and then perform techniques proprioception (group a); and twenty patients not be treated with dry needling after ACL surgery, using only proprioceptive exercises to the joint (group B).


Description:

It carries out a last fifteen days ECA surgical reconstruction of the anterior cruciate ligament. Twenty individuals in a group to be subjected to a technique of physiotherapy, dry needling were included. (Group A). Another group of twenty patients treated with conservative treatment performed a stability exercises and proprioception (Group B). Forty-six patients will be examined s. None had been previously operated by joint instability and all subjects were previously subjected to a diagnostic study by nuclear magnetic resonance before surgery and the diagnosis was confirmed by additional diagnostic testing. All patients will be evaluated by a physical therapist and Myofascial Trigger Point (PGM) of the vastus muscle will be evaluated.

patients using the following variables are evaluated:

- Pain: Visual Analog Scale (VAS) was used.

- Stiffness and physical function using the WOMAC scale (The Western Ontario and McMaster Universities Arthritis Index.).

- Range of motion of the knee joint: Scale ROM.

- Muscular strength, balance and propiocepción: Star Excursion by Balance Scale Test.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- over eighteen and anatomically mature surgically break LCA and valued above using MRI and functional tests to confirm the rupture of the ligament.

Exclusion Criteria:

- Patients who did not reach 18 years of age and those over 55,

- postoperative complications

- cause myofascial or neuropathic pain in the lower limb, as lumba-sacral radiculopathy, neuropraxia, neurotmesis, axonotmesis or meralgia paresthetica;

- fibromyalgia.

- hypothyroidism

- iron deficiencies and patients who had a fear of needles (fear of needles).

- Lower limb differences.

Study Design


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Reconstruction

Intervention

Device:
Dry needling
dry needling Travell and Simons
Other:
Stability and propioception
Start excursion balance test, WOMAC; ROM, EVA.

Locations

Country Name City State
Spain Jorge Velázquez Saornil Madrid

Sponsors (1)

Lead Sponsor Collaborator
European University Spain

Country where clinical trial is conducted

Spain, 

References & Publications (47)

Adachi N, Ochi M, Uchio Y, Iwasa J, Ryoke K, Kuriwaka M. Mechanoreceptors in the anterior cruciate ligament contribute to the joint position sense. Acta Orthop Scand. 2002 Jun;73(3):330-4. — View Citation

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. — View Citation

Alentorn-Geli E, Myer GD, Silvers HJ, Samitier G, Romero D, Lázaro-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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Cimino F, Volk BS, Setter D. Anterior cruciate ligament injury: diagnosis, management, and prevention. Am Fam Physician. 2010 Oct 15;82(8):917-22. Review. — View Citation

Delincé 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. — View Citation

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. German. — View Citation

Domingo A, Mayoral O, Monterde S, Santafé 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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Feb 8. — View Citation

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. — View Citation

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. Review. — View Citation

Koga H, Nakamae A, Shima Y, Iwasa J, Myklebust G, Engebretsen L, Bahr R, Krosshaug T. Mechanisms for noncontact anterior cruciate ligament injuries: knee joint kinematics in 10 injury situations from female team handball and basketball. Am J Sports Med. 2010 Nov;38(11):2218-25. doi: 10.1177/0363546510373570. Epub 2010 Jul 1. — View Citation

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. Epub 2006 Nov 7. — View Citation

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. — View Citation

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. Epub 2004 Jul 20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 May 11. — View Citation

Martín-Pintado Zugasti A, Rodríguez-Fernández ÁL, García-Muro F, López-López A, Mayoral O, Mesa-Jiménez J, Fernández-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. — View Citation

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. — View Citation

Mayoral O, Salvat I, Martín MT, Martín S, Santiago J, Cotarelo J, Rodríguez 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. — View Citation

Myklebust G, Engebretsen L, Braekken IH, Skjølberg 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. — View Citation

Ordahan B, Küçüksen 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. — View Citation

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. — View Citation

Pecos-Martín D, Montañez-Aguilera FJ, Gallego-Izquierdo T, Urraca-Gesto A, Gómez-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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Salom-Moreno J, Ayuso-Casado B, Tamaral-Costa B, Sánchez-Milá Z, Fernández-de-Las-Peñas C, Alburquerque-Sendín 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. — View Citation

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. French. — View Citation

Tekin L, Akarsu S, Durmus O, Cakar E, Dinçer 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 47 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Degree range of motion (ROM) 24 hours
Primary Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) 24 hours
Primary Pain scores visual analog scale (EVA) 24 hours
Primary Scores of STAR BALANCE TEST 24
Secondary Degree range of motion (ROM) 1 week
Secondary Degree range of motion (ROM) 5 weeks
Secondary Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) 1 week
Secondary Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) 5 weeks
Secondary Pain scores visual analog scale (EVA) 1 week
Secondary Pain scores visual analog scale (EVA) 5 weeks
Secondary Scores STAR BALANCE TEST 1week
Secondary Scores STAR BALANCE TEST 5 weeks
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