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

Not Applicable

Completed

• Conditions: Myofascial Pain Syndromes; Dry Needling, Technique for the Treatment of the Myofascial Trigger Points; Elastography
• Interventions: Other: High Intensity Dry Needling; Other: Low intensity Dry Needling; Other: Fascial Mechanotransduction Dry Needling; Other: Technique Placebo of Dry Needling

• Registration Number: NCT02889991
• Lead Sponsor: University of the Basque Country (UPV/EHU)

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.

Study Timeline

• Study Start: 2016-05-02
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Primary Completion: 2017-01-28
• Study Completion: 2017-03-23
• Status Verified: 2017-08
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High Intensity Dry Needling	High Intensity Dry Needling	Maneuver of Input-Output with the acupuncture needle, until the disappearance of local twitch responses or patient tolerance.
Low Intensity Dry Needling	Low intensity Dry Needling	Maximum 10 input-output maneuvers with acupuncture needle or maximum 3 local twitch responses or patient tolerance.
Fascial mechanotransduction Dry needling	Fascial Mechanotransduction Dry Needling	Maneuver of input, screwing and pulling out of the needle acupuncture.
Placebo Dry Needling Technique	Technique Placebo of Dry Needling	Technique is performed with the "Park´s Sham device".

Primary Outcome Measures

Name	Time	Method
Number of input-output of acupuncture needle in the infraspinatus and supraspinatus muscles.	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.
Number of local twitch response in the infraspinatus and supraspinatus muscles.	Three interventions during 40 days.	The limits of number of local twitch response are established in each technique to study.

Secondary Outcome Measures

Name	Time	Method
Feeling of shoulder pain	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)
Life quality related to health shoulder.	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)"
Active joint range of motion	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.
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.	Check with quantitative elastography, the presence or not of fibrosis and / or repair of the myofascial tissue.
Pressure pain threshold	Four interventions during 40 days.	This dependent variable is measured before and after each intervention. We use the electronic algometer as a measurement tool.

Trial Locations

Locations (1)

Physiotherapy Centre FISIOARABA; 🇪🇸 Vitoria, Alava, Spain