NCT06613646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

September 12, 2024

Last Update Submit

November 18, 2025

Conditions

Keywords

Pectoralis Minor SyndromeUltrasound Guided InjectionsHemiplegiaHemiplegic Shoulder Pain

Outcome Measures

Primary Outcomes (2)

  • Pain Relief

    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.

    Baseline, one hour after subacromial bursa injection, one hour after pectoralis minor injection, one week, and one month

  • Passive Range of Motion of Shoulder

    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.

    Baseline, one hour after subacromial bursa injection, one hour after pectoralis minor injection, one week, and one month

Secondary Outcomes (5)

  • Modified Ashworth Scale

    Baseline

  • Brunnstrom Stages of Recovery for Upper Extremity Motor Function and Hand Function

    Baseline

  • Functional Ambulation Scale

    Baseline

  • Subluxation in the glenohumeral joint

    Baseline

  • Overall Improvement

    One hour after subacromial bursa injection, one hour after pectoralis minor injection, one week, one month

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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.

Procedure: Ultrasound-guided injection of the subacromial bursa and pectoralis minorDrug: Lidocaine (drug)

Interventions

Patients will first receive an ultrasound-guided injection of the subacromial bursa. After the subacromial bursa injection, patients will be monitored for 1 hour, after which the level of relief in their complaints will be assessed using the Numeric Rating Scale (NRS), and passive range of motion will be measured. Following the subacromial bursa injection, patients will receive an ultrasound-guided injection of the pectoralis minor muscle. After the pectoralis minor muscle injection, patients will again be monitored for 1 hour, after which the level of relief in their complaints will be assessed using the NRS, and passive range of motion will be measured.

Intervention Arm

5 mL of 2% lidocaine will be used as a local anesthetic for the subacromial bursa injection, and 4 mL of 2% lidocaine will be used for the pectoralis minor muscle injection.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa (IUC)

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (10)

  • Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.

  • Aktas I, Kaya E, Akpinar P, Atici A, Unlu Ozkan F, Palamar D, Akgun K. Spasticity-induced Pectoralis minor syndrome: a case-report. Top Stroke Rehabil. 2020 May;27(4):316-319. doi: 10.1080/10749357.2019.1691807. Epub 2019 Nov 27.

  • Lin PH. Sonographic findings of painful hemiplegic shoulder after stroke. J Chin Med Assoc. 2018 Jul;81(7):657-661. doi: 10.1016/j.jcma.2017.07.018. Epub 2017 Dec 6.

  • Sanders RJ, Annest SJ. Thoracic outlet and pectoralis minor syndromes. Semin Vasc Surg. 2014 Jun;27(2):86-117. doi: 10.1053/j.semvascsurg.2015.02.001. Epub 2015 Feb 18.

  • Lee KW, Choi YJ, Lee HJ, Gil YC, Kim HJ, Tansatit T, Hu KS. Classification of unusual insertion of the pectoralis minor muscle. Surg Radiol Anat. 2018 Dec;40(12):1357-1361. doi: 10.1007/s00276-018-2107-0. Epub 2018 Oct 10.

  • Murie-Fernandez M, Carmona Iragui M, Gnanakumar V, Meyer M, Foley N, Teasell R. [Painful hemiplegic shoulder in stroke patients: causes and management]. Neurologia. 2012 May;27(4):234-44. doi: 10.1016/j.nrl.2011.02.010. Epub 2011 Apr 22. Spanish.

  • Adey-Wakeling Z, Arima H, Crotty M, Leyden J, Kleinig T, Anderson CS, Newbury J; SEARCH Study Collaborative. Incidence and associations of hemiplegic shoulder pain poststroke: prospective population-based study. Arch Phys Med Rehabil. 2015 Feb;96(2):241-247.e1. doi: 10.1016/j.apmr.2014.09.007. Epub 2014 Sep 28.

  • Lindgren I, Jonsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. doi: 10.1161/01.STR.0000254598.16739.4e. Epub 2006 Dec 21.

  • Griffin JW. Hemiplegic shoulder pain. Phys Ther. 1986 Dec;66(12):1884-93. doi: 10.1093/ptj/66.12.1884.

  • Bender L, McKenna K. Hemiplegic shoulder pain: defining the problem and its management. Disabil Rehabil. 2001 Nov 10;23(16):698-705. doi: 10.1080/09638280110062149.

MeSH Terms

Conditions

Hemiplegia

Interventions

LidocainePharmaceutical Preparations

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 26, 2024

Study Start

May 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations