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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Exclusion rate
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Exclusion rate
时间窗: 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
时间窗: Through study completion, an average of 10 months
Average number of participants recruited per month
Refusal rate
时间窗: 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
时间窗: Baseline, immediately after and 24 hours post-treatment evaluation
Number of loss at follow-up
Length of time of the procedure
时间窗: Baseline, immediately after and 24 hours post-treatment evaluation
Average time needed per participant (testing and intervention)
Safety of the procedure: adverse effects
时间窗: Immediately after intervention to 24 hours post-treatment
Listing of any adverse effects
次要结局
- 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)
研究者
Nathaly Gaudreault
Full Professor
Université de Sherbrooke