An interventional study of Dry needling and Sham needling (SN) in Trigger Point Pain, Myofascial and Chronic Shoulder Pain, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-20.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment
Up to 77% of patients with chronic shoulder pain have a trigger point (TrP) in the infraspinatus muscle. These TrPs can lead to pain, limitation of activities and reduced quality of life. Dry needling (DN) is gaining popularity as a treatment for TrPs in physiotherapy. However, its clinical effects remain poorly understood mechanistically and its neurophysiological effects little studied.
The primary objective of this study is to determine the feasibility of a larger scale study.
The secondary objective of this study is to to explore the immediate neurophysiological, biomechanical and clinical effects of DN and sham needling when applied to TrP of the infraspinatus muscle in people with chronic non-traumatic shoulder pain.
Methodology
In this randomized, double-blind, parallel-group trial, twenty adults with chronic non-traumatic shoulder pain and with a infraspinatus TrP will be recruited according to established criteria. Participants will be randomized into two groups: one group (n = 10) receiving a DN in the infraspinatus TrP and another group (n = 10) receiving a sham needling.
Recruitment strategies
Recruitment will be done through posters that will be posted on bulletin boards of the Faculty of Medicine and Health Sciences of the University of Sherbrooke and in physiotherapy clinics in the region. The persons interested will be invited to contact the research assistant in charge of the study to verify their eligibility to participate.
Data collection procedure
The experimental procedure will take place in a laboratory located at the Research Center on Aging in Sherbrooke, Quebec, Canada. Upon arrival, individuals will be greeted by a research assistant. Verification of the presence of TrP in the infraspinatus to confirm eligibility to participate will be carried out by a physiotherapist with more than 20 years of experience in the identification of TrPs and with the application of DN, according to the following procedure: Participants will be asked to lie in a decubitus lateral position on a treatment table and on the asymptomatic side. The upper arm will be supported on a box placed in front of them, so that the muscles can be relaxed, but the arm will be positioned in a and have a slight horizontal adduction to slightly stretch the fibers of the infraspinatus muscle. Manual palpation with flat fingers and perpendicular to the fibers will be used to identify the tight muscle band. Once a tight muscle band has been identified, the physiotherapist will search within this band for a contraction node, namely the TrP. Once she had identified this TrP with a non-toxic black Sharpie pencil, she will validate with the patient that the compression of this TrP reproduces local or referred pain. This pain should correspond to the pain patterns known to the infraspinatus according to Simons and Travell, 1999 and reproduce the pain known by the patient. This pain should be at least a 1/10 intensity on the visual analog scale (VAS). Ineligible participants will receive advices from the physiotherapist as well as a prescription for exercises related to their condition and a list of physiotherapists they can consult.
The research assistant will explain the nature of the project to the selected participants, he will make sure that the participants have no contraindications to receive DN and/or for transcranial magnetic stimulation (TMS) examination, and he will obtain written informed consent. Participants will then complete a questionnaire used to collect baseline medical information.
Intervention (DN and Sham)
DN will be performed by a certified clinician, experienced with the technique. She will explain the purpose of the intervention and she will review the contraindications and precautions for DN to ensure that the procedure is safe. The technique used is recommended by l'Ordre professionnel de la physiothérapie du Québec (OPPQ). The clinician will insert a sterile disposable acupuncture needle, OPTIMED (non-silicone), 40 mm x 0.30 caliber. The direction of the needle will be slightly oblique, directly in the TrP and in the direction of the muscle fibers. The production of a twitch is expected, gliding and rotation of the needle may be performed to produce this effect, if necessary. The needle will be removed after the twitch. The same procedure will be used for the sham group, except that the needle will be inserted at the subcutaneous level, at the depth of the superficial adipous tissues
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion (TMS security):
Intramuscular insertion
Other: Dry needling
Intradermal insertion
Other: Sham needling (SN)
Intramuscular insertion of an OPTIMED 40mm x 0.3mm acupuncture needle in a trigger point of the infraspinatus muscle
Intradermal insertion of an OPTIMED 40mm x 0.3mm acupuncture needle over the infraspinatus region
Recruitment rate
Average number of participants recruited per month
Time frame: Through study completion, an average of 10 months
Exclusion rate
Number of participants excluded from the study due to eligibility criteria (e.g. too narrow, are they clear)
Time frame: Through study completion, an average of 10 months
Refusal rate
Number of participants who refused to participate (e.g. fear of needle, fear of transcranial magnetic stimulation)
Time frame: Through study completion, an average of 10 months
Retention rate
Number of loss at follow-up
Time frame: Baseline, immediately after and 24 hours post-treatment evaluation
Length of time of the procedure
Average time needed per participant (testing and intervention)
Time frame: Baseline, immediately after and 24 hours post-treatment evaluation
Safety of the procedure: adverse effects
Listing of any adverse effects
Time frame: Immediately after intervention to 24 hours post-treatment
Corticospinal excitability of the infraspinatus
Tested with transcranial magnetic stimulation (TMS) connected to a neuronavigation device, characterized by the active motor threshold and expressed in stimulator maximum power percentage
Time frame: At baseline, immediately after intervention, 24 hours after the intervention
Glenohumeral arthrokinematics
Captured images are taken using ultrasound imaging (GE Logiq-e; linear array 5-12MHz) at 0° and 30° of external rotation. Measurements in cm included: 1) subacromial space (position of the humeral head relative to the acromion); 2) anteroposterior position of the humeral head relative to the glenoid.
Time frame: At baseline, immediately after intervention, 24 hours after the intervention
Pressure pain perceived
Obtained using an algometer (directly applied on the TrP; average of three measurements taken at 30 sec. interval), characterized by the threshold of discomfort and expressed in kg.
Time frame: At baseline, immediately after intervention, 24 hours after the intervention
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Université de Sherbrooke