Evolution of Myofascial Pain, Post-dry Needling. Repair and Measuring With Elastography, of Myofascial Tissue.

NCT02889991 | Completed DMC

• 1 other identifier: M10_2015_142_GRANADOS
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the deep dry needling technique as a percutaneous technique included in the professional field of physiotherapy. 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".

Conditions

Myofascial Pain Syndromes; Dry Needling, Technique for the Treatment of the Myofascial Trigger Points; Elastography

Keywords

Myofascial pain.; Myofascial trigger point.; Infraspinatus muscle.; Deep dry needling.; Local twitch response.; Fascial mechanotransduction.; Needle grasp.; Myofascial fibrosis.; Elastography.

Outcome Measures

Primary Outcomes (2)

• Number of input-output of acupuncture needle in the infraspinatus and supraspinatus muscles.

  This outcome only used with High Intensity Dry Needling and Low Intensity Dry Needling techniques. The number of input-output of the acupuncture needle are established in each technique. The first 3 interventions are recorded with a compact sporty camera with a bracket on the head. This method allows recording, specifically, the number of input-output of the acupuncture needle.

  Three interventions during 40 days.

• Number of local twitch response in the infraspinatus and supraspinatus muscles.

  The limits of number of local twitch response are established in each technique to study.

  Three interventions during 40 days.

Secondary Outcomes (5)

• Active joint range of motion

  Four interventions during 40 days.

• Feeling of shoulder pain

  Four interventions during 40 days.

• Life quality related to health shoulder.

  Two interventions during 40 days.

• Pressure pain threshold

  Four interventions during 40 days.

• Quality of the myofascial tissue by elastography

  Two interventions during 40 days. A third intervention at 6 months after the second, to determine the degree of myofascial fibrosis.

Other Outcomes (13)

• Laterality

  One intervention during 40 days.

• Age

  One intervention during 40 days.

• Sex

  One intervention during 40 days.

Study Arms (4)

High Intensity Dry Needling

EXPERIMENTAL

Maneuver of Input-Output with the acupuncture needle, until the disappearance of local twitch responses or patient tolerance.

Other: High Intensity Dry Needling

Low Intensity Dry Needling

EXPERIMENTAL

Maximum 10 input-output maneuvers with acupuncture needle or maximum 3 local twitch responses or patient tolerance.

Other: Low intensity Dry Needling

Fascial mechanotransduction Dry needling

EXPERIMENTAL

Maneuver of input, screwing and pulling out of the needle acupuncture.

Other: Fascial Mechanotransduction Dry Needling

Placebo Dry Needling Technique

SHAM COMPARATOR

Technique is performed with the "Park´s Sham device".

Other: Technique Placebo of Dry Needling

Interventions

High Intensity Dry Needling OTHER

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.

High Intensity Dry Needling

Low intensity Dry Needling OTHER

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.

Low Intensity Dry Needling

Fascial Mechanotransduction Dry Needling OTHER

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.

Fascial mechanotransduction Dry needling

Technique Placebo of Dry Needling OTHER

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.

Also known as: Control Group

Placebo Dry Needling Technique

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Unilateral shoulder pain or referred pain pattern of the infraspinatus muscle.
• 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.

You may not qualify if:

• Conventional pharmacological treatment of NSAIDs and / or muscle relaxants, the 48 hours before or during the study.
• 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.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• FisioAraba Centre Physiotherapy S.C.: collaborator
• Toshiba Medical Systems, S.A.: collaborator
• Metron Medical Supplies S.L.: collaborator
• Novasan, Medical & Health Products: collaborator

Study Sites (1)

Physiotherapy Centre FISIOARABA

Vitoria-Gasteiz, Alava, 01010, Spain

Location

Related Publications (18)

• Page P. Shoulder muscle imbalance and subacromial impingement syndrome in overhead athletes. Int J Sports Phys Ther. 2011 Mar;6(1):51-8.

  PMID: 21655457 BACKGROUND

• Hong CZ. New trends in myofascial pain syndrome. Zhonghua Yi Xue Za Zhi (Taipei). 2002 Nov;65(11):501-12.

  PMID: 12583512 BACKGROUND

• 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.

  PMID: 8043247 BACKGROUND

• 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.

  PMID: 15509461 BACKGROUND

• 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.

  PMID: 20807448 BACKGROUND

• 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.

  PMID: 21745098 BACKGROUND

• 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.

  PMID: 19838864 BACKGROUND

• 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.

  PMID: 18395479 BACKGROUND

• 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.

  PMID: 23346198 BACKGROUND

• 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.

  PMID: 23138883 BACKGROUND

• 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.

  PMID: 15094118 BACKGROUND

• 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.

  PMID: 15851777 BACKGROUND

• 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.

  PMID: 23662122 BACKGROUND

• 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.

  PMID: 19887205 BACKGROUND

• 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.

  PMID: 23444198 BACKGROUND

• 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.

  PMID: 24695087 BACKGROUND

• 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.

  PMID: 19083696 BACKGROUND

• 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.

  PMID: 23265077 BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Francisco Jiménez, PT

  University of Basque Country

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: September 7, 2016
• Study Start: May 2, 2016
• Primary Completion: January 28, 2017
• Study Completion: March 23, 2017
• Last Updated: February 8, 2019

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)