An interventional study of High Intensity Dry Needling and Low intensity Dry Needling in Myofascial Pain Syndromes, Dry Needling, Technique for the Treatment of the Myofascial Trigger Points and Elastography, sponsored by University of the Basque Country (UPV/EHU). Completed at 1 site in Spain. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by University of the Basque Country (UPV/EHU) · Not applicable, Interventional, and Treatment
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".
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:
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.
1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.
This study's enrollment of 77 is above the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →University of the Basque Country (UPV/EHU) is the lead sponsor of 37 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Maneuver of Input-Output with the acupuncture needle, until the disappearance of local twitch responses or patient tolerance.
Other: High 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
Maneuver of input, screwing and pulling out of the needle acupuncture.
Other: Fascial Mechanotransduction Dry Needling
Technique is performed with the "Park´s Sham device".
Other: Technique Placebo of 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.
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.
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 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
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.
Time frame: 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.
Time frame: Three interventions during 40 days.
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.
Time frame: Four interventions during 40 days.
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)
Time frame: Four interventions during 40 days.
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)"
Time frame: Two interventions during 40 days.
Pressure pain threshold
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.
Quality of the myofascial tissue by elastography
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.
Laterality
Indicate which is the injured shoulder (Left or right)
Time frame: One intervention during 40 days.
Age
Indicate patient´s years old
Time frame: One intervention during 40 days.
Sex
Indicate patient´s sex (Male/Female)
Time frame: One intervention during 40 days.
Chronicity of pain
Indicate how long the patient suffers shoulder pain.
Time frame: One intervention during 40 days.
Presence of referred pain pattern in the infraspinatus muscle
Indicate the presence of referred pain pattern (Yes or No)
Time frame: Two interventions during 40 days.
Myofascial trigger points related to shoulder pain
Indicate which are the muscles related to shoulder pain.
Time frame: Two interventions during 40 days.
Practice sport?
Indicate if patient practices sport (Yes or No)
Time frame: One intervention during 40 days.
Sport discipline
Indicate which sport discipline practices the patient.
Time frame: One intervention during 40 days.
Sporty feature
Indicate if the patient uses the shoulder in the sport (Yes or No).
Time frame: One intervention during 40 days.
Years of sport practice
Indicate the number of years practising the sport.
Time frame: One intervention during 40 days.
Hours per week
Indicate how many hours per week does the patient practises the sport.
Time frame: One intervention during 40 days.
Professional activity
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.
Accident during the treatment
Indicate if the patient has suffer any accident during the treatment (Yes or No)
Time frame: One intervention during 40 days.
Plan to share: No
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University of the Basque Country (UPV/EHU)