The Importance of Pectoralis Minor Syndrome in Hemiplegic Shoulder Pain

Not Applicable

Active, not recruiting

• Conditions: Hemiplegic Shoulder Pain; Pectoralis Minor Syndrome
• Interventions: Procedure: Ultrasound-guided injection of the subacromial bursa and pectoralis minor; Drug: Lidocaine (drug)

• Registration Number: NCT06613646
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

Hemiplegic shoulder pain, common in stroke patients, often arises from muscle weakness, imbalance, or joint and nerve issues. Previous case reports in literature suggest that pectoralis minor syndrome may play a significant role in this pain. In current study, the investigators aimed to evaluate the role of the pectoralis minor muscle in patients with hemiplegic shoulder pain and to reveal the contribution of pectoralis minor syndrome to hemiplegic shoulder pain. Additionally, this study may provide fundamental information to improve clinical practice in determining rehabilitation and treatment strategies, contribute to the development of new approaches in managing hemiplegic shoulder pain, and assist in optimizing rehabilitation programs.

Detailed Description

Hemiplegic shoulder pain is a common complication following a stroke, with a prevalence ranging from 22% to 47%, typically occurring two to three months post-stroke. This pain can lead to withdrawal from rehabilitation programs, longer hospital stays, reduced joint mobility, and impaired quality of life. Various factors contribute to its development, including decreased muscle tone, shoulder subluxation, increased muscle tone, impingement syndrome, frozen shoulder, brachial plexus injury, and thalamic syndrome. Among these, subacromial/subdeltoid bursitis is the most frequently reported cause of pain, and significant pain relief following local anesthetic injections into the subacromial/subdeltoid bursa is diagnostic of subacromial impingement syndrome.

Treatment goals for hemiplegic shoulder pain include pain reduction, restoring shoulder mobility, improving functional activities, and preventing degenerative changes. Treatment options range from conservative methods like shoulder slings, range-of-motion exercises, pain relievers, physical therapy, and various injection therapies, to surgical interventions for cases unresponsive to conservative measures.

Pectoralis minor syndrome, associated with hemiplegic shoulder pain, can occur in stroke patients. The pectoralis minor muscle plays a crucial role in shoulder stability and movement. Compression or irritation of neurovascular structures in the retropectoral space by this muscle leads to pectoralis minor syndrome, often diagnosed through clinical evaluation rather than specific radiological or electrophysiological tests. Ultrasound-guided pectoralis minor muscle blocks have become significant in both diagnosis and treatment, demonstrating marked pain reduction in affected patients. Research on pectoralis minor syndrome aims to enhance understanding of its causes, effects, and treatment strategies, contributing to the development of more effective and specific approaches for managing hemiplegic shoulder pain.

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26
• Primary Completion: 2025-05-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Development of spastic hemiplegia due to stroke
• Presence of shoulder pain on the hemiplegic side

Exclusion Criteria

• Lack of medical stability
• Inability to communicate verbally
• History of severe sensitivity to lidocaine injections
• Surgical history related to the hemiplegic shoulder
• Presence of a prosthesis in the hemiplegic shoulder
• Malignancy in the hemiplegic shoulder
• Severe psychiatric illness
• History of injections to the hemiplegic shoulder within the last 6 months
• Pregnancy
• History of inflammatory rheumatic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Lidocaine (drug)	Patients presenting to the outpatient clinic with shoulder pain on the hemiplegic side will first undergo a diagnostic subacromial bursa injection, followed by a pectoralis minor muscle block.
Intervention Arm	Ultrasound-guided injection of the subacromial bursa and pectoralis minor	Patients presenting to the outpatient clinic with shoulder pain on the hemiplegic side will first undergo a diagnostic subacromial bursa injection, followed by a pectoralis minor muscle block.

Primary Outcome Measures

Name	Time	Method
Pain Relief	Baseline, one hour after subacromial bursa injection, one hour after pectoralis minor injection, one week, and one month	Pain will be assessed using the Numerical Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst pain imaginable), at rest, during movement, at night, and overall, both before and after injections into the subacromial bursa and the pectoralis minor muscle. Higher scores indicate worse pain outcomes.
Passive Range of Motion of Shoulder	Baseline, one hour after subacromial bursa injection, one hour after pectoralis minor injection, one week, and one month	Passive shoulder flexion, abduction, and external rotation will be measured with a goniometer. Flexion and abduction will be measured from 0° (no range of motion) to 180° (full range of motion), while external rotation will be measured from 0° to 90°. Higher scores indicate better outcomes in terms of range of motion.

Secondary Outcome Measures

Name	Time	Method
Brunnstrom Stages of Recovery for Upper Extremity Motor Function and Hand Function	Baseline	Upper extremity motor function and hand function will be assessed using the Brunnstrom Stages of Recovery. This scale ranges from Stage 1 (flaccidity, no voluntary movement) to Stage 6 (normal motor function). For both upper extremity motor function and hand function, higher scores indicate better recovery and motor outcomes.
Functional Ambulation Scale	Baseline	Ambulation will be assessed using the Functional Ambulation Scale, which ranges from 0 to 5. A score of 0 indicates the inability to walk or requiring maximal assistance, while a score of 5 indicates independent ambulation on all surfaces without assistance. Higher scores indicate better ambulation outcomes.
Subluxation in the glenohumeral joint	Baseline	It will be assessed by placing the ultrasound probe along the long axis of the humerus over the lateral edge of the acromion. The distance is defined as the relative lateral distance between the lateral edge of the acromion and the nearest edge of the superior part of the greater tuberosity of the humerus. A difference greater than 0.4 cm indicates the presence of subluxation.
Overall Improvement	One hour after subacromial bursa injection, one hour after pectoralis minor injection, one week, one month	Overall improvement will be assessed as a self-reported percentage, ranging from 0% (no improvement) to 100% (complete improvement). Higher percentages indicate better outcomes, with 100% representing full recovery as perceived by the patient.
Modified Ashworth Scale	Baseline	Spasticity in upper extremity muscles will be assessed using the Modified Ashworth Scale (MAS), which ranges from 0 to 4. A score of 0 indicates no increase in muscle tone, while a score of 4 indicates the affected part is rigid in flexion or extension. Higher scores on the MAS indicate worse spasticity outcomes.

Trial Locations

Locations (1)

Istanbul University - Cerrahpasa (IUC); 🇹🇷 Istanbul, Turkey