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Myofascial Pain SyndromesINA-DMDNCT02889991

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

A study testing High Intensity Dry Needling, Low intensity Dry Needling and Fascial Mechanotransduction Dry Needling in people with Myofascial Pain Syndromes and Dry Needling, Technique for the Treatment of the Myofascial Trigger Points, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 49 years
What is being tested?
High Intensity Dry Needling, Low intensity Dry Needling and Fascial Mechanotransduction Dry Needling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
77 participants
Where
1 siteSpain
Study dates
2 May 2016to 23 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Physiotherapy Centre FISIOARABA

    Vitoria-Gasteiz, Alava, 01010

Other trials in Spain

About this study

Official title: Comparative Study, Between Dry Needling Techniques, in the Evolution of Myofascial Pain Shoulder in Athletes. Elastography as Indicator in the Repair of Myofascial Tissue, Post-dry Needling.

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".

Read the detailed description

The myofascial shoulder pain caused by myofascial trigger points, is one of the main causes of medical consultation and functional disability in the general population and particularly in the amateur athlete.

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.

Being tested
High Intensity Dry Needling, Low intensity Dry Needling, Fascial Mechanotransduction Dry Needling, Technique Placebo of Dry Needling
Keywords
Myofascial pain., Myofascial trigger point., Infraspinatus muscle., Deep dry needling., Local twitch response., Fascial mechanotransduction., Needle grasp., Myofascial fibrosis., Elastography.
Medical subject headings
Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Dry NeedlingOther

    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 NeedlingOther

    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 NeedlingOther

    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 NeedlingOther

    Also called Control Group

    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.
Study groups in NCT02889991
Study groupRoleWhat they receive
High Intensity Dry NeedlingExperimentalManeuver of Input-Output with the acupuncture needle, until the disappearance of local twitch responses or patient tolerance.
Receives: Other: High Intensity Dry Needling
Low Intensity Dry NeedlingExperimentalMaximum 10 input-output maneuvers with acupuncture needle or maximum 3 local twitch responses or patient tolerance.
Receives: Other: Low intensity Dry Needling
Fascial mechanotransduction Dry needlingExperimentalManeuver of input, screwing and pulling out of the needle acupuncture.
Receives: Other: Fascial Mechanotransduction Dry Needling
Placebo Dry Needling TechniqueSham comparatorTechnique is performed with the "Park´s Sham device".
Receives: Other: Technique Placebo of Dry Needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Three interventions during 40 days.

  2. 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.

    Measured: Three interventions during 40 days.

Secondary outcomes (5)
  1. Active joint range of motion

    This dependent variable is measured before and after each intervention. We assign the following reference: Active joint range of motion - flexion, Active joint range of motion - abduction, Active joint range of motion - internal rotation and Active joint range of motion - external rotation.

    Measured: Four interventions during 40 days.

  2. Feeling of shoulder pain

    This dependent variable is measured before and after each intervention. We used the "hand-back test" and measure the pain feeling with the Wong-Baker scale. Score 0-5 (0 = No pain, 5 = Hurts worst)

    Measured: Four interventions during 40 days.

  3. Life quality related to health shoulder.

    We measure the shoulder disability in the daily life activities, at work and practising sports with the questionnaire "Disabilities of the Arm, Shoulder and Hand (DASH)"

    Measured: Two interventions during 40 days.

  4. Pressure pain threshold

    This dependent variable is measured before and after each intervention. We use the electronic algometer as a measurement tool.

    Measured: Four interventions during 40 days.

  5. Quality of the myofascial tissue by elastography

    Check with quantitative elastography, the presence or not of fibrosis and / or repair of the myofascial tissue.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2016 (estimated)
  2. Study start2 May 2016
  3. Primary completion28 Jan 2017
  4. Study completion23 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02889991
Sponsor's protocol ID
M10_2015_142_GRANADOS
Acronym
INA-DMD
Status last verified
Aug 2017
First submitted
26 Jul 2016
Last updated
8 Feb 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

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

    PubMed 21655457
  • Hong CZ. New trends in myofascial pain syndrome. Zhonghua Yi Xue Za Zhi (Taipei). 2002 Nov;65(11):501-12.

    PubMed 12583512
  • 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.

    PubMed 8043247
  • 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.

    PubMed 15509461
  • 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.

    PubMed 20807448
  • 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.

    PubMed 21745098
  • 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.

    PubMed 19838864
  • 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.

    PubMed 18395479
  • 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.

    PubMed 23346198
  • 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.

    PubMed 23138883
  • 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.

    PubMed 15094118
  • 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.

    PubMed 15851777
  • 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.

    PubMed 23662122
  • 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.

    PubMed 19887205
  • 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.

    PubMed 23444198

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Dry Needling, Low intensity Dry Needling and Fascial Mechanotransduction Dry Needling in people with Myofascial Pain Syndromes and Dry Needling, Technique for the Treatment of the Myofascial Trigger Points, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of input-output of acupuncture needle in the infraspinatus and supraspinatus muscles. (time frame: Three interventions during 40 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02889991, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.

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