Effects of Suprascapular Nerve Block on Proprioception in Hemiplegic Shoulder Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Laser pointer-assisted joint position sense test
研究概览
简要总结
The purpose of this prospective randomized controlled clinical trial is to evaluate the effect of suprascapular nerve block on shoulder joint proprioception in stroke patients with hemiplegic shoulder pain.
Fourteen patients aged 18-80 years with hemiplegic shoulder pain will be randomized into two groups. One group will receive suprascapular nerve block followed by a standardized physical therapy program, while the control group will receive the same physical therapy program alone.
The primary outcome is shoulder joint proprioception. Secondary outcomes include pain intensity, shoulder range of motion, motor recovery, stroke-specific quality of life, and upper extremity functional outcomes.
The results of this study are expected to clarify the role of suprascapular nerve block on proprioception and rehabilitation outcomes in patients with hemiplegic shoulder pain.
详细描述
Hemiplegic shoulder pain is one of the most common painful complications following stroke, with a reported prevalence ranging from 16% to 84%. Its etiology is multifactorial and primarily includes musculoskeletal pathologies such as adhesive capsulitis, bicipital tendinitis, subacromial bursitis, shoulder subluxation, and rotator cuff disorders. Pain that may be present even at rest or during passive movement, along with reduced shoulder range of motion, represents the leading clinical complaint. Therefore, the main goal of treatment is to reduce pain, increase joint range of motion, and consequently enhance participation in rehabilitation and functional capacity.
Suprascapular nerve block is a widely used intervention to reduce pain and improve shoulder range of motion in patients with hemiplegic shoulder pain. Proprioceptive and nociceptive receptors embedded in the glenohumeral joint capsule and surrounding ligaments play a crucial role in joint stability, and the suprascapular nerve provides major innervation to these structures. Despite its widespread use to facilitate rehabilitation and improve outcomes, the effects of suprascapular nerve block on shoulder joint proprioception and the subsequent impact of potential proprioceptive changes on rehabilitation outcomes have not yet been investigated.
This study is designed as a prospective, controlled, investigator-blinded, parallel-group clinical trial. Fourteen stroke patients aged 18-80 years with hemiplegic shoulder pain will be enrolled and randomized into two groups. After baseline assessment (T0), one group will receive a suprascapular nerve block followed by a standardized physical therapy program, while the control group will receive the same physical therapy program alone. Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3).
The primary objective of this study is to evaluate the effect of suprascapular nerve block on shoulder joint proprioception in stroke patients with hemiplegic shoulder pain. Secondary objectives include assessing its effects on pain intensity, shoulder range of motion, post-stroke motor recovery, stroke-specific quality of life, and upper extremity physical function and symptoms.
The null hypothesis is that suprascapular nerve block does not impair shoulder joint proprioception in patients with post-stroke hemiplegic shoulder pain.
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
- Single (Investigator)
盲法说明
The study is planned as an investigators-blinded study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •Presence of shoulder pain on the hemiplegic side with a Numeric Rating Scale (NRS) score > 3
- •At least 1 month since the cerebrovascular event (subacute and chronic stroke patients)
- •Active shoulder flexion range of motion > 90 degrees (required for the application of the laser pointer-assisted joint position sense test)
- •First-ever, unilateral hemiplegia
排除标准
- •Mini-Mental State Examination score < 24 indicating cognitive impairment
- •Presence of aphasia
- •Shoulder spasticity with a Modified Ashworth Scale score > 2
- •Brunnstrom upper extremity motor stage < 3
- •Botulinum toxin type A injection within the last 3 months to muscles affecting shoulder joint movement (trapezius, levator scapulae, pectoralis major, deltoid, serratus anterior, latissimus dorsi, rhomboids, teres major, biceps, coracobrachialis, triceps, supraspinatus, subscapularis, infraspinatus, and teres minor)
- •Pre-existing shoulder pathology causing pain in the hemiplegic shoulder
- •Presence of neglect syndrome
- •Complex regional pain syndrome, central pain, traumatic brachial plexus injury
- •Change in pain medication during the study period
- •Hypersensitivity to the medication used for suprascapular nerve block (lidocaine)
- •Adhesive capsulitis (frozen shoulder)
- •Other shoulder pathologies such as fractures or joint replacement
研究组 & 干预措施
Suprascapular Nerve Block
Participants in this arm will receive a suprascapular nerve block administered by an experienced physician, followed by a standardized physical therapy and rehabilitation program. The nerve block will be performed using local anesthetic to reduce shoulder pain and facilitate participation in rehabilitation.
干预措施: suprascapular nerve block (Procedure)
Suprascapular Nerve Block
Participants in this arm will receive a suprascapular nerve block administered by an experienced physician, followed by a standardized physical therapy and rehabilitation program. The nerve block will be performed using local anesthetic to reduce shoulder pain and facilitate participation in rehabilitation.
干预措施: physical therapy (Other)
Control
Participants in this arm will receive a standardized physical therapy and rehabilitation program alone, without suprascapular nerve block. The program will be identical to that provided to the experimental arm and will follow routine clinical practice for hemiplegic shoulder pain.
干预措施: physical therapy (Other)
结局指标
主要结局
Laser pointer-assisted joint position sense test
时间窗: This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3)
The validity and reliability of the laser pointer-assisted joint position sense test in patients with shoulder instability were established by Amir K. Vafadar et al., with inter-observer and intra-observer correlation coefficients of 0.78 and 0.86, respectively. In this test, a laser pointer is secured to the patient's arm using a Velcro strap positioned 5 cm proximal to the elbow. With eyes open, the patient is asked to raise the hemiplegic arm to 90 degrees. The laser point is marked on millimeter paper fixed 1 meter in front of the shoulder joint. The patient is then asked, with eyes open, to relocate the same point to learn the joint position. Subsequently, with eyes closed, the patient is asked to identify the same point again. This second point is marked, and the distance from the initial point is measured along the x- and y-axes. The angular deviation of the shoulder joint position is calculated using the tangent formula.
Thumb localization test
时间窗: This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3)
For the assessment of proprioception, the thumb localization test will be performed. The validity and reliability of this test in patients with hemiplegia were established by Otaka et al., with a weighted kappa value of 0.84 for inter-observer measurements, indicating high agreement. With the patient's eyes closed, the patient is asked to locate and grasp the thumb of the affected hand using the fingers of the unaffected hand
次要结局
- Numeric Rating Scale (NRS)(This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3))
- Goniometric measurement(This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3))
- Goal Attainment Scale (GAS)(This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3))
- Fugl-Meyer Assessment - Upper Extremity(This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3))
- Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire(This test will be assessed at baseline (T0). Follow-up assessments will be performed at the end of the 3-week rehabilitation program (T2), and at week 7 (T3))
- Stroke Impact Scale (SIS)(This test will be assessed at baseline (T0). Follow-up assessments will be performed at the end of the 3-week rehabilitation program (T2), and at week 7 (T3))
- Modified Ashworth Scale(This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3))
研究者
merve kocibar
Medical Doctor
Fatih Sultan Mehmet Training and Research Hospital