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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High Intensity Dry Needling
Low intensity Dry Needling
Fascial Mechanotransduction Dry Needling
Technique Placebo of Dry Needling
Sponsored by
University of the Basque Country (UPV/EHU)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring Myofascial pain., Myofascial trigger point., Infraspinatus muscle., Deep dry needling., Local twitch response., Fascial mechanotransduction., Needle grasp., Myofascial fibrosis., Elastography.

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physiotherapy Centre FISIOARABA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

High Intensity Dry Needling

Low Intensity Dry Needling

Fascial mechanotransduction Dry needling

Placebo Dry Needling Technique

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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)
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)"
Pressure pain threshold
This dependent variable is measured before and after each intervention. We use the electronic algometer as a measurement tool.
Quality of the myofascial tissue by elastography
Check with quantitative elastography, the presence or not of fibrosis and / or repair of the myofascial tissue.

Full Information

First Posted
July 26, 2016
Last Updated
February 6, 2019
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
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1. Study Identification

Unique Protocol Identification Number
NCT02889991
Brief Title
Evolution of Myofascial Pain, Post-dry Needling. Repair and Measuring With Elastography, of Myofascial Tissue.
Acronym
INA-DMD
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2, 2016 (Actual)
Primary Completion Date
January 28, 2017 (Actual)
Study Completion Date
March 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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".
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Dry Needling
Arm Type
Experimental
Arm Description
Maneuver of Input-Output with the acupuncture needle, until the disappearance of local twitch responses or patient tolerance.
Arm Title
Low Intensity Dry Needling
Arm Type
Experimental
Arm Description
Maximum 10 input-output maneuvers with acupuncture needle or maximum 3 local twitch responses or patient tolerance.
Arm Title
Fascial mechanotransduction Dry needling
Arm Type
Experimental
Arm Description
Maneuver of input, screwing and pulling out of the needle acupuncture.
Arm Title
Placebo Dry Needling Technique
Arm Type
Sham Comparator
Arm Description
Technique is performed with the "Park´s Sham device".
Intervention Type
Other
Intervention Name(s)
High Intensity Dry Needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Low intensity Dry Needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fascial Mechanotransduction Dry Needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Technique Placebo of Dry Needling
Other Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of input-output of acupuncture needle in the infraspinatus and supraspinatus muscles.
Description
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.
Time Frame
Three interventions during 40 days.
Title
Number of local twitch response in the infraspinatus and supraspinatus muscles.
Description
The limits of number of local twitch response are established in each technique to study.
Time Frame
Three interventions during 40 days.
Secondary Outcome Measure Information:
Title
Active joint range of motion
Description
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.
Time Frame
Four interventions during 40 days.
Title
Feeling of shoulder pain
Description
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)
Time Frame
Four interventions during 40 days.
Title
Life quality related to health shoulder.
Description
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)"
Time Frame
Two interventions during 40 days.
Title
Pressure pain threshold
Description
This dependent variable is measured before and after each intervention. We use the electronic algometer as a measurement tool.
Time Frame
Four interventions during 40 days.
Title
Quality of the myofascial tissue by elastography
Description
Check with quantitative elastography, the presence or not of fibrosis and / or repair of the myofascial tissue.
Time Frame
Two interventions during 40 days. A third intervention at 6 months after the second, to determine the degree of myofascial fibrosis.
Other Pre-specified Outcome Measures:
Title
Laterality
Description
Indicate which is the injured shoulder (Left or right)
Time Frame
One intervention during 40 days.
Title
Age
Description
Indicate patient´s years old
Time Frame
One intervention during 40 days.
Title
Sex
Description
Indicate patient´s sex (Male/Female)
Time Frame
One intervention during 40 days.
Title
Chronicity of pain
Description
Indicate how long the patient suffers shoulder pain.
Time Frame
One intervention during 40 days.
Title
Presence of referred pain pattern in the infraspinatus muscle
Description
Indicate the presence of referred pain pattern (Yes or No)
Time Frame
Two interventions during 40 days.
Title
Myofascial trigger points related to shoulder pain
Description
Indicate which are the muscles related to shoulder pain.
Time Frame
Two interventions during 40 days.
Title
Practice sport?
Description
Indicate if patient practices sport (Yes or No)
Time Frame
One intervention during 40 days.
Title
Sport discipline
Description
Indicate which sport discipline practices the patient.
Time Frame
One intervention during 40 days.
Title
Sporty feature
Description
Indicate if the patient uses the shoulder in the sport (Yes or No).
Time Frame
One intervention during 40 days.
Title
Years of sport practice
Description
Indicate the number of years practising the sport.
Time Frame
One intervention during 40 days.
Title
Hours per week
Description
Indicate how many hours per week does the patient practises the sport.
Time Frame
One intervention during 40 days.
Title
Professional activity
Description
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).
Time Frame
One intervention during 40 days.
Title
Accident during the treatment
Description
Indicate if the patient has suffer any accident during the treatment (Yes or No)
Time Frame
One intervention during 40 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Jiménez, PT
Organizational Affiliation
University of Basque Country
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy Centre FISIOARABA
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Evolution of Myofascial Pain, Post-dry Needling. Repair and Measuring With Elastography, of Myofascial Tissue.

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