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临床试验/NCT05368649
NCT05368649已完成不适用

Sensory Processing and Pain Modulatory Mechanisms Associated With Characteristics of the Infraspinatus Muscle in Individuals With and Without Shoulder Pain

University of Gran Rosario2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
Conditioned pain modulation (CPM)

研究概览

简要总结

The development of chronic pain is a common complication in shoulder pain conditions. Half of these type of patients exhibit persistent pain even after a period of six to twelve months from the start of their pain treatment. Persistent pain is most likely a result of different biological alterations, including but not limited to tissue damage. Another potential cause is neurogenic inflammation, which can be triggered by applying excessive mechanical stress to a structure or region. Neurogenic inflammation can lead to peripheral sensitization and sensitizing the musculoskeletal tissues in the process, and this sensitization will last until the input is removed. Nevertheless, even though peripheral factors are sufficient to perpetuate pain, the role of central mechanisms cannot be excluded as a potential cause of sensitization. Moreover, the evidence is not conclusive about deficiencies in pain modulation processes and presence of central mechanisms in chronic pain conditions.

It is well known that chronic shoulder pain presents a multi-factorial nature. Hypersensitivity in this condition has been linked to persistent activation of peripheral nerves, which can result in an increased excitability of the sensory input and reduced inhibitory effect of pain modulatory mechanisms. On the other hand, the role the central sensitization plays is not completely clear in this type of patients, but could also contribute to the hypersensitivity in some patients.However, it has been shown that there is a remarkable variability in the presence of central effects among chronic patients. The aim of this study is to evaluate changes in sensory processing and in pain modulatory mechanisms in individuals with and without shoulder pain.

详细描述

This quasi-experimental study comprise a sample of 64 volunteers with and without unilateral shoulder pain (32 volunteers for each group). Patients of both genders, aged between 18 and 35 years old will be potential candidates for participating in the study. To be included, they must meet inclusion and exclusion criteria. Inclusion criteria for the patient group requires volunteers to report unilateral shoulder pain for more than 6 weeks and to be symptomatic at the time of evaluation.

The study will be conducted in two experimental sessions on different days, at least 48 to 72 hours apart each other in order to avoid carryover effects. In each experimental session, several measurements will be performed to assess different physiological parameters, including: visual analog scale (VAS), pressure pain thresholds (PPT), temperature thresholds, specific and generic self-report questionnaire, shoulder joint position sense, and muscle activity. In order to test change induced by transient muscle pain, healthy participants will receive shortwave diathermy (SWD) applications. Volunteers will be invited to participate in the study through social networks and e-mail.

In the first session, participants will be interviewed to collect anthropometric data and health history. Basic upper quadrant physical examination will be performed to check inclusion or exclusion criteria. Then, VAS, shoulder joint position sensation, American Shoulder and Elbow Surgeons (ASES) score, and Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) will be assessed. Heat and cold perception threshold as well as heat pain threshold will be assessed using a controlled thermode. Finally, to conclude the first session, conditioned pain modulation (CPM) will be performed to asses inhibitory descendent mechanisms. The CPM protocol will use a cold water bath as the conditioned stimulus, and pressure pain thresholds will be quantify in the belly of the infraspinatus muscle of both shoulders before and after immersion of the hand in cold bath.

In the second session, shortwave diathermy (SWD) will be apply to the healthy participants in order to induce a transient muscle pain. The stimulation will be performed using a CEC M-8 shortwave thermotherapy unit. Before and after the SWD, infraspinatus muscle and deltoid muscle myoelectric activity will be recorded. A multichannel array (6 channels) will be distributed over the infraspinatus muscle to evaluate changes in the distribution of the muscle activity due to pain, whereas monopolar recording will be performed in the medial and posterior deltoid muscle to assess potential crosstalk between recordings. The volunteers will position the arm in 90 degree elevation in the scapular plane (arm flexion), maintaining this position for 8 seconds. This block will be completed in 5 repetitions with 15 seconds of rest between for each trial. Finally, a fatigue task will be executed. For this, flexion and extension of the arm will be executed dynamically in a range of motion between 30 and 90 degree in the scapular plane using a additional weight calculated according to the volunteer body mass (1.25 kg in participants under 68 kg and 2.5 kg in participants over 68 kg). The flexion and extension speed will be guided using a 60 beats/s metronome. In this session, unilateral shoulder pain volunteers will only performed the motor tasks, i.e., they will not received any type of intervention. The healthy and unilateral shoulder pain volunteers will draw their pain distribution on a digital body chart (following the physiotherapist's instructions). Pain drawings will be performed using a PC screen. A modified self-report Likert scale and will be used to follow the temporal progression of muscle pain/soreness, and the McGill questionnaires will be used to describe the sensation.

Sample size considerations:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

PPT measurements and data analysis will be conducted by assessors blind to group allocation.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers with unilateral shoulder pain and mechanosensitivity in the infraspinatus muscle
  • pain lasting more than 6 weeks
  • Healthy volunteers

排除标准

  • Previous surgery/trauma in the upper limb
  • Previous physiotherapy treatments in the shoulder
  • Pain intensity ≤ 2 and > 9 (VAS)
  • History of neurologic disorders
  • Systemic disorders
  • Cervical spine injuries or postural deformities
  • Cortisone injections within the last 6 months
  • Unusually strenuous activity 48 h before the testing session
  • Glenohumeral instability
  • Articular Hyperlaxitude (Beighton > 4)

结局指标

主要结局

Conditioned pain modulation (CPM)

时间窗: At baseline and immediately after the cold-water immersion in the first session.

CPM will be assessed by immersing the hand up to the wrist in a cold water bath (0.6-0.8°) with a circulating water pump. The dominant arm for healthy and the symptomatic side for unilateral shoulder pain volunteers will be immerse in the cold-water bath. In general, the conditioning stimulus will be applied for 2 min or maximum tolerance (whichever comes first). A computerized, custom-made visual analog scale (VAS) will be used to continuously track the response profile to conditional stimuli across participants during the application of CPM. A numeric rating scale ranging from 0 to 100, where 0 represents no perception, 30 represents pain threshold (defined as the time to reach a painful sensation at the predefined stimulation intensity) and 100 represents the tolerance threshold (defined as the sensation of pain when becomes intolerable). Before and immediately after the immersion, PPT measurements will be assessed on both infraspinatus muscles.

Pressure pain threshold (PPT)

时间窗: At baseline and 30 - 60 minutes after the short-wave diathermia in the second session.

Change in the PPT (kPa) will be assessed bilaterally over the medial portion of the infraspinatus muscle using a digital algometer (Somedic SenseLab AB, Sweden) with a 1-cm2 round tip. Pressure will be gradually increased from 0 kPa at a rate of approximately 50 kPa/s (maximal achievable pressure: 2,000 kPa). The volunteers will be asked to press the button when they perceive that the pressure changes to pain, stopping the estimation at this point. The assessment will be repeated 3 times for each sides, alternating sides between measurements. Each measure will be performed at 30-second intervals.

次要结局

  • Thermal sensitivity thresholds(At baseline in the first session.)
  • Pain intensity(At baseline in the first session.)
  • Myoelectrical activity (EMG)(At 10 minutes before and 30 - 60 minutes after the application of SWD for control in the second session.)
  • Örebro Musculoskeletal Pain Questionnaire (ÖMPQ)(At baseline in the first session.)
  • American Shoulder and Elbow Surgeons score (ASES)(At baseline in the first session.)
  • Shoulder joint position sensation(At baseline in the first session.)
  • Pain distribution(At 15 - 30 minutes before recording of muscle activity for chronic patients and 30 - 60 minutes after the application of SWD for control in the second session.)
  • Modified Likert scale(At 15 - 30 minutes before recording of muscle activity for chronic patients and 30 - 60 minutes after the application of SWD for control in the second session.)
  • McGill questionnaires(At 15 - 30 minutes before recording of muscle activity for chronic patients and 30 - 60 minutes after the application of SWD for control in the second session.)

研究者

发起方
University of Gran Rosario
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Intelangelo

Head of the University Center for Assistance, Teaching and Research

University of Gran Rosario

研究点 (2)

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