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临床试验/NCT06635759
NCT06635759尚未招募不适用

The Effect of Low-load Endurance Training of Upper Trapezius on Pain, Pressure Pain and Muscle Stiffness in Chronic Neck-shoulder Pain Compared to Stretching Exercise: a Randomized Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1
主要终点
Pain

研究概览

简要总结

This study aims to investigate the effectiveness of low-load endurance exercise as compared to stretching exercise on upper trapezius on pain, pressure pain and muscle stiffness in patients with chronic neck-shoulder pain. The hypothesis is that endurance exercise of the upper trapezius should result in significantly better improvement in terms of neck-shoulder pain, pressure pain threshold and muscle stiffness than stretching exercise.

Participants with unilateral neck-shoulder pain will either perform low-load endurance exercise or stretching exercise of the upper trapezius muscle of the affected side in a 5-week period. Before and after the 5-week training, outcomes will be assessed by investigators in order to compare the effectiveness of two exercises on pain, pressure pain, muscle stiffness, and muscle endurance. Secondary outcomes include Neck Disability Index (NDI) to assess various aspects of daily living impacted by neck pain, and Disabilities of Shoulder, Arm and Hand (DASH) Questionnaire to evaluate the ability to perform various upper limb activities.

Findings to be obtained from this study will help inform the clinical management in particular for self-care of this chronic neck pain group of participants, by refining the exercise prescription for promoting the clinical outcomes for individuals suffering from neck-shoulder pain. In addition, results of this study will also inform physiotherapists the possible mechanisms underlying the improvement of neck-shoulder pain by examination of the relationship between biomechanical properties of muscles, such as muscle endurance or muscle stiffness, and neck-shoulder pain.

详细描述

  1. Introduction:

Neck-shoulder pain, also known as the proxy for neck or shoulder pain in research of global burden of diseases, is one of the leading causes of disability and is a common work-related musculoskeletal disorder in workers performing static or repetitive work, leading to huge socio-economic burdens worldwide. It was revealed that about 203 million people suffered from neck-shoulder pain globally. Owing to factors such as aging population and increasing prevalence of sedentary lifestyle, the related burden of neck-shoulder pain on the individuals and health care system is expected to be increasing. Therefore, effective intervention, particularly the active and self-care approach, is needed to address this issue.

Exercise therapy is one of the widely used interventions for chronic neck-shoulder pain because exercise is relatively safe with temporary and benign side effects. Examples of active exercises for neck-shoulder pain include but are not limited to specific neck and shoulder stretching, strengthening and endurance training, cervico-scapulothoracic stabilization exercises, neuromuscular exercises with eye-neck coordination and proprioceptive training, and mindfulness exercises. Evidence has shown that strengthening exercises, when combined with either endurance or stretching exercise, has been shown to be beneficial for neck-shoulder pain. Nevertheless, when either stretching or endurance exercise is incorporated as the only intervention, it appears to have minimal effect on pain and function. Due to the lack of high quality evidence, there is still uncertainty concerning the effectiveness of these specified types of exercise for management of neck-shoulder pain.

Muscle stiffness refers to the tissue resistance during passive stretching and it would depend on the type of external force applied and the deformation of the structure caused. Thus, muscles can be stretched without tearing for flexibility and joint range of motion, demonstrating extensibility, and they can return to their original form after being stretched or contracted, demonstrating elasticity. These mechanical properties allow muscles to function effectively for generating movement, stabilizing joints, and maintaining postures. Some evidence has shown that neck-shoulder pain is related to increased stiffness of the upper trapezius muscle. Recent studies have also demonstrated the association between the myofascial stiffness, elasticity and chronic neck-shoulder pain. However, the precise association between upper trapezius 'tightness' and neck-shoulder pain remains unclear. A possible explanation is that altered tissue morphology of the myofascia leads to altered muscle imbalance between prevertebral and spinal extensor muscles. On the contrary, another possible mechanism is that increased muscle tone in upper trapezius is a protective strategy to limit painful neck movements, which mimics the phenomenon that increased stiffness in trunk extensor muscles among low back pain patients.

If muscle stiffness of upper trapezius is associated with neck-shoulder pain, it is expected that lengthening or releasing its muscle tone should induce long-term improvement in terms of pain. Yet, neck muscle stretching and acupuncture, addressing the myofascial stiffness and trigger point, has been associated with short-term relief from neck-shoulder pain only. Accordingly, active trigger points appear in the upper trapezius among 40% of mechanical neck-shoulder pain. Hence, stretching exercise might alleviate short-term pain only by targeting trigger points rather than addressing muscle stiffness by inhibiting dorsal horn of nociception. As a result, neck-shoulder pain will still be present in the long term due to the nociceptive input resulting in the formation of new trigger points.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •(1) are between 20 and 60 years of age;
  • •(2) have worked with Display Screen Equipment (DSE) for a minimum of 20 hours per week;
  • •(3) are presenting persistent, non-specific pain over unilateral neck-shoulder region for more than 3 months, with at least 30 days of pain during the last year;
  • •(4) have average pain rating of Visual Analogue Scale (VAS) larger than 3.4 centimeter out of 10 (moderate level of pain) during the week before data collection;
  • •(5) possess the range of motion of cervical rotation to the symptomatic side more than that of cervical rotation to the asymptomatic side with at least 10° difference as measured by placing a goniometric measurement sensor on the external occipital tuberosity (the lower edge of the upper sensor) and the spinous process of C7 vertebrae (the upper edge of the lower sensor), which may indicate "pseudo-tightness" of upper trapezius over the symptomatic side.

排除标准

  • •(1) have regular strength training of the neck and upper limbs during the year before the study;
  • •(2) have neck-shoulder pain with specific diagnosis or known cause, for instance cervical radiculopathy, prolapse of intervertebral disc or disc herniation, or with neurological deficits and symptoms;
  • •(3) have previous cervical spine or upper limb surgery;
  • •(4) have comorbidity which includes but is not limited to neurological disease such as stroke, Parkinson's disease or spinal cord injury, mental illness, heart disease, diagnosis of carpal tunnel syndrome or fibromyalgia; or
  • •(5) contraindicated for electrical stimulation which will be involved during assessment, such as impaired skin sensation and/or conditions, pregnancy, local malignancy or recently radiated tissue, electronic implant or metal implant, actively bleeding tissue.

研究组 & 干预措施

Experimental Group: Upper trapezius low-load endurance exercise (EE) group

Experimental

Participants in the EE group will perform the overhead shrug exercise for the affected side using a green Thera-Band Elastic Band. To perform this exercise, the subject will stand and place one arm of the affected side in an overhead position against the wall. The middle portion of the theraband will be placed on the floor, and the subject will stand on the middle portion of the theraband to fixate it in place with both feet shoulder-width apart. Then, the subject grasp both tails of the theraband and perform the shoulder shrug movement for the affected side with a 3-second elevation, hold at the end range for 5 seconds, and then return back to the starting position with a 3-second depression. The subject will perform this exercise for 20 repetitions per set, 3 sets a day with 1-minute rest between sets, 3 alternate days a week, for 5 weeks. They will be instructed to record all training sessions in a diary.

干预措施: Upper trapezius low-load endurance exercise (Other)

Comparison Group: Upper trapezius stretching exercise (SE) group

Active Comparator

Participants in the SE group will perform static upper trapezius stretching exercise for the affected side. To perform the stretch, participants will be asked to sit upright on a chair and look straight ahead. To reduce scapular elevation and upward rotation, the ipsilateral hand should be placed below the buttock. The subject will then be asked to perform deep neck flexion, neck rotation towards the affected side, and contralateral side flexion using the opposite hand in a diagonal direction until the position of 'mild discomfort' is attained. They should maintain the deep neck flexion when performing the stretch. The stretch will be held for 30 seconds each set, 3 sets a day, daily for 5 weeks.

干预措施: Upper trapezius stretching exercise (Other)

结局指标

主要结局

Pain

时间窗: From enrollment to the end of treatment at 5 weeks

The average neck-shoulder pain will be indicated by a mark on a 10-cm VAS scale with the leftmost value representing 'no pain (0)' and rightmost value representing 'the worst pain (10)'. The VAS is the most commonly used method to assess neck-shoulder pain intensity, and its test-retest reliability for neck pain is very high, with an intraclass correlation coefficient (ICC) of 0.97.

Muscle stiffness of upper trapezius

时间窗: From enrollment to the end of treatment at 5 weeks

Muscle stiffness of the upper trapezius will be measured using a handheld myotonometer device, MyotonPRO. MyotonPRO is a non-invasive, portable device that uses superficial mechanical deformation to assess the biomechanical characteristics of soft tissues. The subject will be tested in a seated position in a chair with back support. The myotonometer will be positioned vertically on the 2 designated points of the upper trapezius. The probe will apply a compression force of 0.18 N, followed by a 5-time mechanical impulse (0.4 N for 15 ms). Stiffness (N/m) will be measured. The measurement will be done on each spot for 3 times in order to obtain an average stiffness (N/m). The stiffness of upper trapezius on both sides will be measured.

Pressure Pain Threshold (PPT)

时间窗: From enrollment to the end of treatment at 5 weeks

PPT, the minimum pressure force (kPa) required to evoke pain, will be assessed using a handheld electronic pressure algometer over the upper trapezius. Pressure algometry is a reliable tool for assessing chronic neck pain, with an ICC ranging from 0.78 to 0.93. After the myotonometry measurement is completed, the subject will lie prone on a plinth for the PPT measurement. The same 2 designated points used for the myotonometry measurement will be assessed. During the test, the algometer will be placed perpendicular to the skin and apply an increasing pressure at a constant rate. The subject will press a handheld button when the pressure exerted turns to pain. The measurement will be done on each spot for 3 times in order to obtain an average (N/cm square), and it will be performed on both sides.

Upper Trapezius Endurance

时间窗: From enrollment to the end of treatment at 5 weeks

The muscle endurance of upper trapezius will be measured objectively utilizing a 5-minute electrical stimulation protocol, which was adopted in a previous study. Two silicon electrodes will be placed at two points: one point just lateral to C7 spinous process and the other point medial to acromion, with ultrasound gel applied underneath the electrodes. A tri-axial accelerometer will be positioned between the two electrodes. The upper trapezius will be stimulated with a current level that produces a visually noticeable and comfortable contraction in the subject. Then, the intensity will be adjusted to achieve a vigorous contraction ranging from 25mA to 30mA, with a pulse duration of 200μs. The electrical stimulation will last for 5 minutes at a frequency of 5Hz. The endurance index (EI) will be calculated by dividing the peak twitches at the end of the acceleration by the peak twitches at the start, expressed as a percentage.

次要结局

  • Neck Disability Index (NDI)(From enrollment to the end of treatment at 5 weeks)
  • Disabilities of Shoulder, Arm and Hand (DASH) Questionnaire(From enrollment to the end of treatment at 5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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