Evolution of Myofascial Pain, Post-dry Needling. Repair and Measuring With Elastography, of Myofascial Tissue.
NCT ID: NCT02889991
Last Updated: 2019-02-08
Study Results
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Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2016-05-02
2017-03-23
Brief Summary
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The project quantifies a significant limit on the number of local twitch responses necessary for the favorable treatment of myofascial pain and analyzes the injury degree and/or the repair of myofascial tissue, with "Elastography".
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Detailed Description
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Nowadays, many physiotherapists all over the world, study and practice the dry needling as a therapeutic tool for the treatment of myofascial trigger points. The most used modality is the technique described by Hong:
* This technique introduces an acupuncture needle in the skin until reaching the dysfunctional muscle fiber. To do so, it uses maneuvers "fast in" and "fast out" of needle, until the extinction of local twitch responses or the tolerance of the patient.
* The local twitch response is defined as a reflex and transitory contraction of a group of muscle fibers associated with a myofascial trigger points.
* The technique eliminates muscle contractile activity by mechanical interruption of their muscle fibers, mechanism which finishes with the sensitization of nearby nerves and with the start of the nociceptive modulation peripheral, segmental and central.
The dry needling technique, in its eagerness to obtain local twitch responses, pierces the muscle fibers both dysfunctional and normal, the fascial tissue that wraps the myofascial trigger points and also neuro-vascular structures. That is, the treatment of myofascial trigger points with dry needling, makes reference to a mechanical trauma done with a acupuncture needle.
The myofascial tissue injured can suffer repair or regeneration, which is mainly due to the extension of the lesion. The process of healing of a wound is strictly regulated by multiple growth factors and cytokines, which are released into the wound. The alterations that disturb the healing process, can lead to chronic wounds that do not heal or to an excessive fibrosis.
The pathobiological processes, in form of fibrosis, would present changes in stiffness and elasticity of the neo-tissue. The quantitative elastography, is shown as an effective tool to measure the amount of fibrosis, occasioned by repeated percussion of the acupuncture needle on the myofascial tissue.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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High Intensity Dry Needling
Maneuver of Input-Output with the acupuncture needle, until the disappearance of local twitch responses or patient tolerance.
High Intensity Dry Needling
This technique follows the criteria established by Dr Hong C-Z. This technique is known as "fast in and fast out technique" and uses repeated insertion of the acupuncture needle in the myofascial trigger point, with the aim to get multiple local twitch responses. The technique ends when the local twitch responses disappear.
Low Intensity Dry Needling
Maximum 10 input-output maneuvers with acupuncture needle or maximum 3 local twitch responses or patient tolerance.
Low intensity Dry Needling
Technique proposed by the main investigator and based on the studies of Professor Dr. Jay P. Shah and the mechanisms of neuromodulation that transmits us the acupuncture scientific evidence.
Fascial mechanotransduction Dry needling
Maneuver of input, screwing and pulling out of the needle acupuncture.
Fascial Mechanotransduction Dry Needling
The Fascial Mechanotransduction Dry Needling Technique, strikes with the acupuncture needle until it reaches and pierces the myofascial trigger point. Then the acupuncture needle is rolled in the connective tissue, which causes an intense coupler that we define as "needle grasp". Finally, the acupuncture needling is pulled-out twice.
The screwing and the two pull-out of the acupuncture needle is performed in the infraspinatus and supraspinatus muscles and we describe it as mechanotransduction cycle. Each cycle lasts 30 seconds and the whole technique lasts 3 minutes per session.
Placebo Dry Needling Technique
Technique is performed with the "Park´s Sham device".
Technique Placebo of Dry Needling
Technique with a total duration of 3 minutes per session:
* To locate the myofascial trigger points of infraspinatus and supraspinatus muscles and put each bridle on them.
* Monitor longitudinally taut band, with index and middle fingers.
* Percuss with tube and needle placebo (Sham needle) on Infraspinatus.
* Remove the tube and needle placebo from the device. Reintroducing the placebo needle into the tube and strike on the supraspinatus. Repeat this sequence without interruption for 3 minutes.
* Remove the bridles and perform hemostasis with cotton.
* We will give end to the technique placebo of dry needling.
Interventions
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High Intensity Dry Needling
This technique follows the criteria established by Dr Hong C-Z. This technique is known as "fast in and fast out technique" and uses repeated insertion of the acupuncture needle in the myofascial trigger point, with the aim to get multiple local twitch responses. The technique ends when the local twitch responses disappear.
Low intensity Dry Needling
Technique proposed by the main investigator and based on the studies of Professor Dr. Jay P. Shah and the mechanisms of neuromodulation that transmits us the acupuncture scientific evidence.
Fascial Mechanotransduction Dry Needling
The Fascial Mechanotransduction Dry Needling Technique, strikes with the acupuncture needle until it reaches and pierces the myofascial trigger point. Then the acupuncture needle is rolled in the connective tissue, which causes an intense coupler that we define as "needle grasp". Finally, the acupuncture needling is pulled-out twice.
The screwing and the two pull-out of the acupuncture needle is performed in the infraspinatus and supraspinatus muscles and we describe it as mechanotransduction cycle. Each cycle lasts 30 seconds and the whole technique lasts 3 minutes per session.
Technique Placebo of Dry Needling
Technique with a total duration of 3 minutes per session:
* To locate the myofascial trigger points of infraspinatus and supraspinatus muscles and put each bridle on them.
* Monitor longitudinally taut band, with index and middle fingers.
* Percuss with tube and needle placebo (Sham needle) on Infraspinatus.
* Remove the tube and needle placebo from the device. Reintroducing the placebo needle into the tube and strike on the supraspinatus. Repeat this sequence without interruption for 3 minutes.
* Remove the bridles and perform hemostasis with cotton.
* We will give end to the technique placebo of dry needling.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pain Intensity with a minimum score of 2 on the Wong-Baker scale, using the homolateral "test hand-back".
* Process time more than 1 and less than 10 weeks.
* Age of 18 years old to 49 years old.
* Written Informed Form.
Exclusion Criteria
* Coagulation pathology or anticoagulant therapy.
* Pretreatment with infiltration and / or steroid injections during the last year.
* Physiotherapy Pretreatment, in the cervical region or shoulder girdle during or in the last week taking part in the study.
* Dry needling pretreatment in the cervical region and / or shoulder girdle during or in the last month before taking part in the study.
* History of fracture or dislocation of the shoulder to study, in the last year.
* Dermatological disorders or erosions in the treatment area (infraspinatus fossa).
* Metals allergy such as chromium or nickel.
* Fibromyalgia diagnosis, myelopathy, cervical radiculopathy or neurologic disease.
* Fear of needles.
* Pregnant women.
* Suffering a traumatic accident of the upper extremity and / or cervical-thoracic spine during the study (it will pass to the zero week).
* Medical-legal litigious, by financial compensation.
* Drugs or alcohol abuse / consumption history.
* Cognitive inability to complete the health forms.
18 Years
49 Years
ALL
No
Sponsors
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FisioAraba Centre Physiotherapy S.C.
UNKNOWN
Toshiba Medical Systems, S.A.
UNKNOWN
Metron Medical Supplies S.L.
UNKNOWN
Novasan, Medical & Health Products
UNKNOWN
University of the Basque Country (UPV/EHU)
OTHER
Responsible Party
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Francisco jiménez Hidalgo
Physiotherapist
Principal Investigators
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Francisco Jiménez, PT
Role: PRINCIPAL_INVESTIGATOR
University of Basque Country
Locations
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Physiotherapy Centre FISIOARABA
Vitoria-Gasteiz, Alava, Spain
Countries
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References
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Page P. Shoulder muscle imbalance and subacromial impingement syndrome in overhead athletes. Int J Sports Phys Ther. 2011 Mar;6(1):51-8.
Hong CZ. New trends in myofascial pain syndrome. Zhonghua Yi Xue Za Zhi (Taipei). 2002 Nov;65(11):501-12.
Hong CZ. Lidocaine injection versus dry needling to myofascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994 Jul-Aug;73(4):256-63. doi: 10.1097/00002060-199407000-00006.
Gerwin RD, Dommerholt J, Shah JP. An expansion of Simons' integrated hypothesis of trigger point formation. Curr Pain Headache Rep. 2004 Dec;8(6):468-75. doi: 10.1007/s11916-004-0069-x.
Cotchett MP, Landorf KB, Munteanu SE. Effectiveness of dry needling and injections of myofascial trigger points associated with plantar heel pain: a systematic review. J Foot Ankle Res. 2010 Sep 1;3:18. doi: 10.1186/1757-1146-3-18.
Huang YT, Lin SY, Neoh CA, Wang KY, Jean YH, Shi HY. Dry needling for myofascial pain: prognostic factors. J Altern Complement Med. 2011 Aug;17(8):755-62. doi: 10.1089/acm.2010.0374. Epub 2011 Jul 11.
Ay S, Evcik D, Tur BS. Comparison of injection methods in myofascial pain syndrome: a randomized controlled trial. Clin Rheumatol. 2010 Jan;29(1):19-23. doi: 10.1007/s10067-009-1307-8. Epub 2009 Oct 20.
Tough EA, White AR, Cummings TM, Richards SH, Campbell JL. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of randomised controlled trials. Eur J Pain. 2009 Jan;13(1):3-10. doi: 10.1016/j.ejpain.2008.02.006. Epub 2008 Apr 18.
Hsieh YL, Yang SA, Yang CC, Chou LW. Dry needling at myofascial trigger spots of rabbit skeletal muscles modulates the biochemicals associated with pain, inflammation, and hypoxia. Evid Based Complement Alternat Med. 2012;2012:342165. doi: 10.1155/2012/342165. Epub 2012 Dec 23.
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.
Midwood KS, Williams LV, Schwarzbauer JE. Tissue repair and the dynamics of the extracellular matrix. Int J Biochem Cell Biol. 2004 Jun;36(6):1031-7. doi: 10.1016/j.biocel.2003.12.003.
Jarvinen TA, Jarvinen TL, Kaariainen M, Kalimo H, Jarvinen M. Muscle injuries: biology and treatment. Am J Sports Med. 2005 May;33(5):745-64. doi: 10.1177/0363546505274714.
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.
Sikdar S, Shah JP, Gebreab T, Yen RH, Gilliams E, Danoff J, Gerber LH. Novel applications of ultrasound technology to visualize and characterize myofascial trigger points and surrounding soft tissue. Arch Phys Med Rehabil. 2009 Nov;90(11):1829-38. doi: 10.1016/j.apmr.2009.04.015.
Langevin HM, Nedergaard M, Howe AK. Cellular control of connective tissue matrix tension. J Cell Biochem. 2013 Aug;114(8):1714-9. doi: 10.1002/jcb.24521.
Ingber DE, Wang N, Stamenovic D. Tensegrity, cellular biophysics, and the mechanics of living systems. Rep Prog Phys. 2014 Apr;77(4):046603. doi: 10.1088/0034-4885/77/4/046603.
Shah JP, Gilliams EA. Uncovering the biochemical milieu of myofascial trigger points using in vivo microdialysis: an application of muscle pain concepts to myofascial pain syndrome. J Bodyw Mov Ther. 2008 Oct;12(4):371-384. doi: 10.1016/j.jbmt.2008.06.006. Epub 2008 Aug 13.
Leung L. Neurophysiological basis of acupuncture-induced analgesia--an updated review. J Acupunct Meridian Stud. 2012 Dec;5(6):261-70. doi: 10.1016/j.jams.2012.07.017. Epub 2012 Aug 22.
Other Identifiers
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M10_2015_142_GRANADOS
Identifier Type: -
Identifier Source: org_study_id
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