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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Université de Sherbrooke
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Exclusion rate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dry needling (DN)
Intramuscular insertion
Intervention: Dry needling (Other)
Sham needling (SN)
Intradermal insertion
Intervention: Sham needling (SN) (Other)
Outcomes
Primary Outcomes
Exclusion rate
Time Frame: Through study completion, an average of 10 months
Number of participants excluded from the study due to eligibility criteria (e.g. too narrow, are they clear)
Recruitment rate
Time Frame: Through study completion, an average of 10 months
Average number of participants recruited per month
Refusal rate
Time Frame: Through study completion, an average of 10 months
Number of participants who refused to participate (e.g. fear of needle, fear of transcranial magnetic stimulation)
Retention rate
Time Frame: Baseline, immediately after and 24 hours post-treatment evaluation
Number of loss at follow-up
Length of time of the procedure
Time Frame: Baseline, immediately after and 24 hours post-treatment evaluation
Average time needed per participant (testing and intervention)
Safety of the procedure: adverse effects
Time Frame: Immediately after intervention to 24 hours post-treatment
Listing of any adverse effects
Secondary Outcomes
- Pressure pain perceived(At baseline, immediately after intervention, 24 hours after the intervention)
- Corticospinal excitability of the infraspinatus(At baseline, immediately after intervention, 24 hours after the intervention)
- Glenohumeral arthrokinematics(At baseline, immediately after intervention, 24 hours after the intervention)
Investigators
Nathaly Gaudreault
Full Professor
Université de Sherbrooke