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

February 6, 2019 updated by: Francisco jiménez Hidalgo, University of the Basque Country (UPV/EHU)

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alava
      • Vitoria, Alava, Spain, 01010
        • Physiotherapy Centre FISIOARABA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Intensity Dry Needling
Maneuver of Input-Output with the acupuncture needle, until the disappearance of local twitch responses or patient tolerance.
Other: 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.
Experimental: Low Intensity Dry Needling
Maximum 10 input-output maneuvers with acupuncture needle or maximum 3 local twitch responses or patient tolerance.
Other: 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.
Experimental: Fascial mechanotransduction Dry needling
Maneuver of input, screwing and pulling out of the needle acupuncture.
Other: 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.
Sham Comparator: Placebo Dry Needling Technique
Technique is performed with the "Park´s Sham device".
Other: 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 Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of input-output of acupuncture needle in the infraspinatus and supraspinatus muscles.
Time Frame: Three interventions during 40 days.

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.
Time Frame: Three interventions during 40 days.
The limits of number of local twitch response are established in each technique to study.
Three interventions during 40 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active joint range of motion
Time Frame: Four interventions during 40 days.
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.
Four interventions during 40 days.
Feeling of shoulder pain
Time Frame: Four interventions during 40 days.
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)
Four interventions during 40 days.
Life quality related to health shoulder.
Time Frame: Two interventions during 40 days.
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)"
Two interventions during 40 days.
Pressure pain threshold
Time Frame: Four interventions during 40 days.
This dependent variable is measured before and after each intervention. We use the electronic algometer as a measurement tool.
Four interventions during 40 days.
Quality of the myofascial tissue by elastography
Time Frame: Two interventions during 40 days. A third intervention at 6 months after the second, to determine the degree of myofascial fibrosis.
Check with quantitative elastography, the presence or not of fibrosis and / or repair of the myofascial tissue.
Two interventions during 40 days. A third intervention at 6 months after the second, to determine the degree of myofascial fibrosis.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laterality
Time Frame: One intervention during 40 days.
Indicate which is the injured shoulder (Left or right)
One intervention during 40 days.
Age
Time Frame: One intervention during 40 days.
Indicate patient´s years old
One intervention during 40 days.
Sex
Time Frame: One intervention during 40 days.
Indicate patient´s sex (Male/Female)
One intervention during 40 days.
Chronicity of pain
Time Frame: One intervention during 40 days.
Indicate how long the patient suffers shoulder pain.
One intervention during 40 days.
Presence of referred pain pattern in the infraspinatus muscle
Time Frame: Two interventions during 40 days.
Indicate the presence of referred pain pattern (Yes or No)
Two interventions during 40 days.
Myofascial trigger points related to shoulder pain
Time Frame: Two interventions during 40 days.
Indicate which are the muscles related to shoulder pain.
Two interventions during 40 days.
Practice sport?
Time Frame: One intervention during 40 days.
Indicate if patient practices sport (Yes or No)
One intervention during 40 days.
Sport discipline
Time Frame: One intervention during 40 days.
Indicate which sport discipline practices the patient.
One intervention during 40 days.
Sporty feature
Time Frame: One intervention during 40 days.
Indicate if the patient uses the shoulder in the sport (Yes or No).
One intervention during 40 days.
Years of sport practice
Time Frame: One intervention during 40 days.
Indicate the number of years practising the sport.
One intervention during 40 days.
Hours per week
Time Frame: One intervention during 40 days.
Indicate how many hours per week does the patient practises the sport.
One intervention during 40 days.
Professional activity
Time Frame: One intervention during 40 days.
Indicate if the patient lifts up or not the upper limb, over 90 ° of flexion and / or abduction in his or her job (Yes or No).
One intervention during 40 days.
Accident during the treatment
Time Frame: One intervention during 40 days.
Indicate if the patient has suffer any accident during the treatment (Yes or No)
One intervention during 40 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Basque Country (UPV/EHU)

Collaborators

FisioAraba Centre Physiotherapy S.C.
Toshiba Medical Systems, S.A.
Metron Medical Supplies S.L.
Novasan, Medical & Health Products

Investigators

  • Principal Investigator: Francisco Jiménez, PT, University of Basque Country

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2016

Primary Completion (Actual)

January 28, 2017

Study Completion (Actual)

March 23, 2017

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10_2015_142_GRANADOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myofascial Pain Syndromes

Clinical Trials on High Intensity Dry Needling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe