Effects of Dry Needling When Applied to the Infraspinatus Muscle in People With Chronic Shoulder Pain
Primary Purpose
Trigger Point Pain, Myofascial, Chronic Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dry needling
Sham needling (SN)
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Point Pain, Myofascial focused on measuring Dry needling, Infraspinatus, Neurophysiological effects
Eligibility Criteria
Inclusion Criteria:
- Unilateral, chronic non-traumatic shoulder pain (VAS ≥ 2/10; >3 months)
- Localized pain in the shoulder region or referred according to the territory of the infraspinatus (Travell and Simons, 1999)
- Presence of a palpable nodule inside a tight muscle band reproducing the patient's pain
Exclusion Criteria:
- Cancer or metastasis in organs or tissues above the pelvis (< 5 years)
- Shoulder capsulitis
- Shoulder, thorax or mastectomy surgeries
- Shoulder bone fracture (< 6 months)
- C4-C5 or C6 radiculopathy
- Osteoporosis or excessive atrophy of the infraspinous fossa (infraspinatus <10 mm)
- Body mass index (BMI) > 28
Exclusion (TMS security):
- Pregnant woman
- Neurological, psychiatric or epilepsy conditions
- Implants (e.g. Neurostimulator, pacemaker, cerebral aneurysm clip, screw or plate), metallic foreign body in the eye
- Head trauma with loss of consciousness
Sites / Locations
- Centre de Recherche sur le Vieillissement
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Dry needling (DN)
Sham needling (SN)
Arm Description
Intramuscular insertion
Intradermal insertion
Outcomes
Primary Outcome Measures
Recruitment rate
Average number of participants recruited per month
Exclusion rate
Number of participants excluded from the study due to eligibility criteria (e.g. too narrow, are they clear)
Refusal rate
Number of participants who refused to participate (e.g. fear of needle, fear of transcranial magnetic stimulation)
Retention rate
Number of loss at follow-up
Length of time of the procedure
Average time needed per participant (testing and intervention)
Safety of the procedure: adverse effects
Listing of any adverse effects
Secondary Outcome Measures
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
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.
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.
Full Information
NCT ID
NCT04316793
First Posted
March 11, 2020
Last Updated
March 18, 2020
Sponsor
Université de Sherbrooke
Collaborators
Ordre Professionnel de la Physiothérapie du Québec (OPPQ), Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT04316793
Brief Title
Effects of Dry Needling When Applied to the Infraspinatus Muscle in People With Chronic Shoulder Pain
Official Title
Neurophysiological, Biomechanical and Clinical Effects of Dry Needling Versus Sham Needling When Applied to the Infraspinatus Muscle in People With Chronic Shoulder Pain: a Randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 3, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Ordre Professionnel de la Physiothérapie du Québec (OPPQ), Centre de recherche du Centre hospitalier universitaire de Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial, Chronic Shoulder Pain
Keywords
Dry needling, Infraspinatus, Neurophysiological effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry needling (DN)
Arm Type
Experimental
Arm Description
Intramuscular insertion
Arm Title
Sham needling (SN)
Arm Type
Sham Comparator
Arm Description
Intradermal insertion
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Intramuscular insertion of an OPTIMED 40mm x 0.3mm acupuncture needle in a trigger point of the infraspinatus muscle
Intervention Type
Other
Intervention Name(s)
Sham needling (SN)
Intervention Description
Intradermal insertion of an OPTIMED 40mm x 0.3mm acupuncture needle over the infraspinatus region
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Average number of participants recruited per month
Time Frame
Through study completion, an average of 10 months
Title
Exclusion rate
Description
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
Title
Refusal rate
Description
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
Title
Retention rate
Description
Number of loss at follow-up
Time Frame
Baseline, immediately after and 24 hours post-treatment evaluation
Title
Length of time of the procedure
Description
Average time needed per participant (testing and intervention)
Time Frame
Baseline, immediately after and 24 hours post-treatment evaluation
Title
Safety of the procedure: adverse effects
Description
Listing of any adverse effects
Time Frame
Immediately after intervention to 24 hours post-treatment
Secondary Outcome Measure Information:
Title
Corticospinal excitability of the infraspinatus
Description
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
Title
Glenohumeral arthrokinematics
Description
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
Title
Pressure pain perceived
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral, chronic non-traumatic shoulder pain (VAS ≥ 2/10; >3 months)
Localized pain in the shoulder region or referred according to the territory of the infraspinatus (Travell and Simons, 1999)
Presence of a palpable nodule inside a tight muscle band reproducing the patient's pain
Exclusion Criteria:
Cancer or metastasis in organs or tissues above the pelvis (< 5 years)
Shoulder capsulitis
Shoulder, thorax or mastectomy surgeries
Shoulder bone fracture (< 6 months)
C4-C5 or C6 radiculopathy
Osteoporosis or excessive atrophy of the infraspinous fossa (infraspinatus <10 mm)
Body mass index (BMI) > 28
Exclusion (TMS security):
Pregnant woman
Neurological, psychiatric or epilepsy conditions
Implants (e.g. Neurostimulator, pacemaker, cerebral aneurysm clip, screw or plate), metallic foreign body in the eye
Head trauma with loss of consciousness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaly Gaudreault, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mélanie Morin, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Guillaume Léonard, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Director
Facility Information:
Facility Name
Centre de Recherche sur le Vieillissement
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Dry Needling When Applied to the Infraspinatus Muscle in People With Chronic Shoulder Pain
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